CATROP-2007: Local Anesthesia Versus Saline Serum in Surgical Incision of Colorectal or Hepatic Surgery
Sponsor
Hospital Universitari de Bellvitge (Other)
Overall Status
Completed
CT.gov ID
NCT01075646
Collaborator
(none)
225
1
2
63
3.6
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether a continuous infusion of local anesthesia with a catheter in the surgical wound reduces patient consumption of opiates by 30% in the 48-hour postoperative period following surgery for colorectal neoplasm and hepatic surgery versus the continuous infusion of physiological serum.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Postoperative analgesia in major abdominal surgery is managed with intravenous PCA (patient controlled analgesia) with morphine associated to non-steroidal anti-inflammatories drugs (NSAD) and paracetamol in the first 48 hours of the postoperative phase. With this multimodal approach patients undergoing colorectal surgery have a median pain score on the verbal scale (0-10) of 3 (range 0-8) with a mean of morphine consumption of 54 mg (SD 24 mg) and patients undergoing hepatic surgery have a median pain score of 2(range 0-7) with a mean of morphine consumption of 28 mg (SD 17 mg).
Although opiates are very potent analgesics they also produce side effects and numerous studies have demonstrated a significant reduction in morbidity when patients received lower dose of opiates during anesthesia and in postoperative period. Continuous infusion of local anesthetics in the surgical wound has been used for pain control in different types of surgeries. However, controversial reports has been reported in abdominal surgery.
We are conducting prospective, randomised and double-blind placebo control trials in two surgical models (colo-rectal oncologic surgery and hepatic resection) using continuous perfusion of ropivacaine 0.38% in the surgical wound versus saline.
Anesthetic protocol is the same for all patients.
Patients undergoing colo-rectal surgery can be operated either in laparotomy or laparoscopic technique therefore patients are stratified into four groups once surgical closure has begun:
-
Group A1 ropivacaine and laparotomy
-
Group A2 ropivacaine and laparoscopy
-
Group B1 saline and laparotomy
-
Group B2 saline and laparoscopy
In the preanesthesia visit patients who match inclusion criteria are invited to participate in the study and they signed the informed consent. When the patient is in the theatre a nurse not involved in the management of patients opens a closed envelope which indicates the solution to be prepared according to the assigned group.
The surgeon inserts a multiperforated catheter at the subfascial level of surgical wound , just below the suture of the muscular fascia (between the peritoneum and the muscular fascia) and after that surgeons finish the subcutaneous plane and the skin. After the closure a bolus of 5 ml (laparoscopy colon surgery)or 10 ml (laparotomy colon and hepatic surgery) of the solution is given through the catheter and subsequently an elastomer filled with ropivacaine or saline is connected. The catheter is fixed to the skin with steri-strip and sterile dressing.
During the procedure we administer in a protocol basis the NSAD and thirty minutes before the end of the surgery we administer morphine. In the postoperative period the patient receives a NSAD regime and a PCA morphine treatment.
The catheter is withdrawn after 48 hours and also the PCA and the analgesic treatment is with NSAD.
Study Design
Study Type:
Interventional
Actual Enrollment
:
225 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Randomised and Double-blind Clinical Trial on Post-operative Analgesic Efficacy in Colorectal Surgery and Hepatic Surgery With Continuous Infusion of Local Anesthesia vs Saline Serum in the Surgical Incision.
Study Start Date
:
Mar 1, 2009
Actual Primary Completion Date
:
Jun 1, 2014
Actual Study Completion Date
:
Jun 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ropivacaine After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours |
Drug: ropivacaine
Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.
Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h.
Hepatic surgery: 10 ml de ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
Other Names:
|
| Placebo Comparator: saline solution After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours |
Drug: saline solution
Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.
Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h.
Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System [48 hours]
Secondary Outcome Measures
- Intensity of Pain Measured by Verbal Pain Scale. [At interval periods during 48 hours]
Verbal pain scale is a numeric measure of intensity pain, values range from 0 (no pain) to 10 (excruciating pain), Each patient rate the paín that feel with a number from 0 to 10.
- Time Spent Sitting in a Chair, Deambulation, Solid Ingestion. [7 Days (from Day 8-15)]
- Secondary Effects Due to Morphine: Nausea and Vomiting [during 48 hours]
- Local Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection) [During 8-15 days]
- Contamination of the Catheter (Microbiologist Analysis) [at 48 hours]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
ASA I-III
-
Undergoing scheduled colorectal cancer and hepatic surgery
-
Patients must be able to understand the PCA (the self administration system)
Exclusion Criteria:
-
Background of allergic reaction or contraindication for local anesthesia or non steroid anti-inflammatory drugs.
-
Patient with epidural catheter or receiving combined analgesia during surgery (age above 80, moderate-severe respiratory dysfunction, patients who prior presented complex postoperative pain management.
-
Emergency surgery
-
Patients with risk of hepatic insufficiency (Klatskin's tumor, extended right hepatectomy, right hepatectomy in patients with steatosis, hepatic resection in patients over 70 years of age who have been given chemotherapy).
-
Inflammatory bowel disease: ulcerative colitis, Crohn's disease.
-
Major psychiatric condition.
-
Patients with active drug addiction or on chronic treatment with opiates.
-
Morbid obesity (BMI > 35 kg/m2)
-
Patients with heart disease (myocardiopathy, conduction alterations, antiarrhythmic treatment) and severe liver disease (alteration synthesis, histolysis and or cholestasis).
-
Patients with kidney failure.
-
Patients treated with fluvoxamine (antidepressant) and enoxacin (antibiotic) both are potent inhibitors of CYPIA2.
-
Septic patients
-
Patients that do not wish to participate.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Anesthesiology Service of Univeritary Hospital of Bellvitge | Hospitalet . Barcelona | Barcelona | Spain | 08907 |
Sponsors and Collaborators
- Hospital Universitari de Bellvitge
Investigators
- Study Director: Antònia Dalmau Llitjós, Physical D, Univeritary Hospital of Bellvitge. IDIBELL
Study Documents (Full-Text)
None provided.More Information
Publications
- Baig MK, Zmora O, Derdemezi J, Weiss EG, Nogueras JJ, Wexner SD. Use of the ON-Q pain management system is associated with decreased postoperative analgesic requirement: double blind randomized placebo pilot study. J Am Coll Surg. 2006 Feb;202(2):297-305.
- Beaussier M, El'Ayoubi H, Schiffer E, Rollin M, Parc Y, Mazoit JX, Azizi L, Gervaz P, Rohr S, Biermann C, Lienhart A, Eledjam JJ. Continuous preperitoneal infusion of ropivacaine provides effective analgesia and accelerates recovery after colorectal surgery: a randomized, double-blind, placebo-controlled study. Anesthesiology. 2007 Sep;107(3):461-8.
- Chester JF, Ravindranath K, White BD, Shanahan D, Taylor RS, Lloyd-Williams K. Wound perfusion with bupivacaine: objective evidence for efficacy in postoperative pain relief. Ann R Coll Surg Engl. 1989 Nov;71(6):394-6.
- Fredman B, Zohar E, Tarabykin A, Shapiro A, Mayo A, Klein E, Jedeikin R. Bupivacaine wound instillation via an electronic patient-controlled analgesia device and a double-catheter system does not decrease postoperative pain or opioid requirements after major abdominal surgery. Anesth Analg. 2001 Jan;92(1):189-93.
- Gupta A, Perniola A, Axelsson K, Thörn SE, Crafoord K, Rawal N. Postoperative pain after abdominal hysterectomy: a double-blind comparison between placebo and local anesthetic infused intraperitoneally. Anesth Analg. 2004 Oct;99(4):1173-1179. doi: 10.1213/01.ANE.0000130260.24433.A2.
- Liu SS, Richman JM, Thirlby RC, Wu CL. Efficacy of continuous wound catheters delivering local anesthetic for postoperative analgesia: a quantitative and qualitative systematic review of randomized controlled trials. J Am Coll Surg. 2006 Dec;203(6):914-32. Epub 2006 Oct 25. Review.
- Wu CL, Partin AW, Rowlingson AJ, Kalish MA, Walsh PC, Fleisher LA. Efficacy of continuous local anesthetic infusion for postoperative pain after radical retropubic prostatectomy. Urology. 2005 Aug;66(2):366-70.
- Zohar E, Fredman B, Phillipov A, Jedeikin R, Shapiro A. The analgesic efficacy of patient-controlled bupivacaine wound instillation after total abdominal hysterectomy with bilateral salpingo-oophorectomy. Anesth Analg. 2001 Aug;93(2):482-7, 4th contents page.
Responsible Party:
antonia dalmau llitjos,
MD PhD,
Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT01075646
Other Study ID Numbers:
- ANESTHESIA SERVICE HUB
First Posted:
Feb 25, 2010
Last Update Posted:
Mar 27, 2017
Last Verified:
Feb 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by antonia dalmau llitjos,
MD PhD,
Hospital Universitari de Bellvitge
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Study recruitment took place at the hospital Universitari de Bellvitge in Barcelona, Spain, from April 2010 to April 2012 in the case of colorrectal surgery. In hepatic surgery the study recruitment took place at the same hospital, from April 2010 to June 2014. |
|---|---|
| Pre-assignment Detail | In colorrectal surgery 117 patients were assessed for elegibility. Of these 50 patients were excluded before randomization including 23 with exclusion criteria and 18 with a surgical or organization reason. In hepatic surgery 108 patients were assesed for eligibility, 9 patients were excluded with a surgical reason. |
| Arm/Group Title | Ropivacaine Colorectal Surgery | Saline Solution Colorectal Surgery | Ropivacaine Hepatic Surgery | Saline Solution Hepatic Surgery |
|---|---|---|---|---|
| Arm/Group Description | After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h. Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h. | After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h. Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h. | After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h. | After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h |
| Period Title: Overall Study | ||||
| STARTED | 33 | 34 | 53 | 46 |
| COMPLETED | 29 | 31 | 52 | 44 |
| NOT COMPLETED | 4 | 3 | 1 | 2 |
Baseline Characteristics
| Arm/Group Title | Ropivacaine Colorectal Surgery | Saline Solution Colorectal Surgery | Ropivacaine Hepatic Surgery | Saline Solution Hepatic Surgery | Total |
|---|---|---|---|---|---|
| Arm/Group Description | After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h. Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h. | After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h. Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h. | After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h. | After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h | Total of all reporting groups |
| Overall Participants | 33 | 34 | 53 | 46 | 166 |
| Age (years) [Median (Inter-Quartile Range) ] | |||||
| Median (Inter-Quartile Range) [years] |
64
|
64.5
|
63.62
|
59.73
|
62.96
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
13
39.4%
|
8
23.5%
|
14
26.4%
|
17
37%
|
52
31.3%
|
| Male |
20
60.6%
|
26
76.5%
|
39
73.6%
|
29
63%
|
114
68.7%
|
| Hypertension (participants) [Number] | |||||
| Yes |
15
45.5%
|
17
50%
|
23
43.4%
|
15
32.6%
|
70
42.2%
|
| No |
18
54.5%
|
17
50%
|
30
56.6%
|
31
67.4%
|
96
57.8%
|
| Diabetes (participants) [Number] | |||||
| Yes |
10
30.3%
|
7
20.6%
|
10
18.9%
|
11
23.9%
|
38
22.9%
|
| No |
23
69.7%
|
27
79.4%
|
43
81.1%
|
35
76.1%
|
128
77.1%
|
| Antiplatelet drugs (participants) [Number] | |||||
| Yes |
5
15.2%
|
4
11.8%
|
3
5.7%
|
1
2.2%
|
13
7.8%
|
| No |
28
84.8%
|
30
88.2%
|
50
94.3%
|
45
97.8%
|
153
92.2%
|
| Anemia (participants) [Number] | |||||
| Yes |
3
9.1%
|
2
5.9%
|
2
3.8%
|
2
4.3%
|
9
5.4%
|
| No |
30
90.9%
|
32
94.1%
|
51
96.2%
|
44
95.7%
|
157
94.6%
|
| Stroke (participants) [Number] | |||||
| Yes |
3
9.1%
|
1
2.9%
|
2
3.8%
|
2
4.3%
|
8
4.8%
|
| No |
30
90.9%
|
33
97.1%
|
51
96.2%
|
44
95.7%
|
158
95.2%
|
| Myocardial disease (participants) [Number] | |||||
| Yes |
1
3%
|
0
0%
|
2
3.8%
|
2
4.3%
|
5
3%
|
| No |
32
97%
|
34
100%
|
51
96.2%
|
44
95.7%
|
161
97%
|
| Chronic respiratory insuficiency (participants) [Number] | |||||
| Yes |
6
18.2%
|
0
0%
|
1
1.9%
|
0
0%
|
7
4.2%
|
| No |
27
81.8%
|
34
100%
|
52
98.1%
|
46
100%
|
159
95.8%
|
| Surgical procedure (participants) [Number] | |||||
| Right hemicolectomy |
7
21.2%
|
5
14.7%
|
0
0%
|
0
0%
|
12
7.2%
|
| Left hemicolectomy |
14
42.4%
|
15
44.1%
|
0
0%
|
0
0%
|
29
17.5%
|
| Total colectomy |
1
3%
|
4
11.8%
|
0
0%
|
0
0%
|
5
3%
|
| Rectal resections |
11
33.3%
|
10
29.4%
|
0
0%
|
0
0%
|
21
12.7%
|
| mayor hepatectomy |
0
0%
|
0
0%
|
22
41.5%
|
17
37%
|
39
23.5%
|
| minor hepatectomy |
0
0%
|
0
0%
|
30
56.6%
|
29
63%
|
59
35.5%
|
| radiofrequency |
0
0%
|
0
0%
|
1
1.9%
|
0
0%
|
1
0.6%
|
| Duration of surgery (minutes) [Median (Inter-Quartile Range) ] | |||||
| Median (Inter-Quartile Range) [minutes] |
205
|
225
|
274.26
|
263.57
|
241.95
|
| Size of incision (cm) [Median (Inter-Quartile Range) ] | |||||
| Median (Inter-Quartile Range) [cm] |
16.5
|
17.5
|
31.5
|
29.67
|
23.79
|
Outcome Measures
| Title | Mg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System |
|---|---|
| Description | |
| Time Frame | 48 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ropivacaine Colorectal Surgery | Saline Solution Colorectal Surgery | Ropivacaine Hepatic Surgery | Saline Solution Hepatic Surgery |
|---|---|---|---|---|
| Arm/Group Description | After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h. Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h. | After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h. Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h. | After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h. | After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h |
| Measure Participants | 29 | 31 | 52 | 44 |
| Median (Inter-Quartile Range) [mg] |
23
|
52
|
24.63
|
26.78
|
| Title | Intensity of Pain Measured by Verbal Pain Scale. |
|---|---|
| Description | Verbal pain scale is a numeric measure of intensity pain, values range from 0 (no pain) to 10 (excruciating pain), Each patient rate the paín that feel with a number from 0 to 10. |
| Time Frame | At interval periods during 48 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ropivacaine Colorectal Surgery | Saline Solution Colorectal Surgery | Ropivacaine Hepatic Surgery | Saline Solution Hepatic Surgery |
|---|---|---|---|---|
| Arm/Group Description | After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h. Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h. | After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h. Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h. | After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h. | After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h |
| Measure Participants | 33 | 34 | 53 | 46 |
| Verbal numeric scale 0h after surgery |
1
|
2.5
|
2.75
|
2.5
|
| Verbal numeric scale 6h after surgery |
2
|
3
|
1.72
|
2.38
|
| Verbal numeric scale 12h after surgery |
2
|
2
|
1.45
|
1.8
|
| Verbal numeric scale 24h after surgery |
2
|
2
|
1.64
|
2
|
| Verbal numeric scale 48h after surgery |
2
|
2
|
1.62
|
2.14
|
| Title | Time Spent Sitting in a Chair, Deambulation, Solid Ingestion. |
|---|---|
| Description | |
| Time Frame | 7 Days (from Day 8-15) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ropivacaine Colorectal Surgery | Saline Solution Colorectal Surgery | Ropivacaine Hepatic Surgery | Saline Solution Hepatic Surgery |
|---|---|---|---|---|
| Arm/Group Description | After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h. Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h. | After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h. Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h. | After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h. | After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h |
| Measure Participants | 33 | 34 | 53 | 46 |
| Sitting in the chair |
46
|
48
|
51.75
|
43.2
|
| Deambulation |
72
|
72
|
81.2
|
87.37
|
| Solid food intake |
96
|
120
|
88
|
79.79
|
| Title | Secondary Effects Due to Morphine: Nausea and Vomiting |
|---|---|
| Description | |
| Time Frame | during 48 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ropivacaine Colorectal Surgery | Saline Solution Colorectal Surgery | Ropivacaine Hepatic Surgery | Saline Solution Hepatic Surgery |
|---|---|---|---|---|
| Arm/Group Description | After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h. Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h. | After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h. Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h. | After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h. | After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h |
| Measure Participants | 33 | 34 | 53 | 46 |
| Yes |
5
15.2%
|
6
17.6%
|
2
3.8%
|
6
13%
|
| No |
28
84.8%
|
28
82.4%
|
51
96.2%
|
40
87%
|
| Title | Local Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection) |
|---|---|
| Description | |
| Time Frame | During 8-15 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ropivacaine Colorectal Surgery | Saline Solution Colorectal Surgery | Ropivacaine Hepatic Surgery | Saline Solution Hepatic Surgery |
|---|---|---|---|---|
| Arm/Group Description | After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h. Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h. | After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h. Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h. | After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h. | After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h |
| Measure Participants | 33 | 34 | 53 | 46 |
| Yes |
6
18.2%
|
10
29.4%
|
2
3.8%
|
2
4.3%
|
| No |
27
81.8%
|
24
70.6%
|
51
96.2%
|
44
95.7%
|
| Title | Contamination of the Catheter (Microbiologist Analysis) |
|---|---|
| Description | |
| Time Frame | at 48 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Ropivacaine Colorectal Surgery | Saline Solution Colorectal Surgery | Ropivacaine Hepatic Surgery | Saline Solution Hepatic Surgery |
|---|---|---|---|---|
| Arm/Group Description | After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h. Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h. | After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h. Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h. | After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h. | After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h |
| Measure Participants | 33 | 34 | 53 | 46 |
| Yes |
6
18.2%
|
4
11.8%
|
2
3.8%
|
2
4.3%
|
| No |
27
81.8%
|
30
88.2%
|
51
96.2%
|
44
95.7%
|
Adverse Events
| Time Frame | We collected all adverse events appeared in the hospitalary period | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Ropivacaine Colorectal Surgery | Saline Solution Colorectal Surgery | Ropivacaine Hepatic Surgery | Saline Solution Hepatic Surgery | ||||
| Arm/Group Description | After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h. Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h. | After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h. Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h. | After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h. | After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h | ||||
All Cause Mortality |
||||||||
| Ropivacaine Colorectal Surgery | Saline Solution Colorectal Surgery | Ropivacaine Hepatic Surgery | Saline Solution Hepatic Surgery | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Ropivacaine Colorectal Surgery | Saline Solution Colorectal Surgery | Ropivacaine Hepatic Surgery | Saline Solution Hepatic Surgery | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/33 (0%) | 0/34 (0%) | 0/53 (0%) | 0/46 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Ropivacaine Colorectal Surgery | Saline Solution Colorectal Surgery | Ropivacaine Hepatic Surgery | Saline Solution Hepatic Surgery | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/33 (0%) | 0/34 (0%) | 0/53 (0%) | 0/46 (0%) | ||||
Limitations/Caveats
A limitation of the study is the high number of recruited patients who were excluded before ranodmization.
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Noelia Fustran |
|---|---|
| Organization | Department of Anesthesia, Reanimation Bellvitge University Hospital |
| Phone | 932607323 |
| nfustran@bellvitgehospital.cat |
Responsible Party:
antonia dalmau llitjos,
MD PhD,
Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT01075646
Other Study ID Numbers:
- ANESTHESIA SERVICE HUB
First Posted:
Feb 25, 2010
Last Update Posted:
Mar 27, 2017
Last Verified:
Feb 1, 2017