Effect of Paracervical Block on Post Operative Pain in Laparoscopic Gynecologic Surgery

• Sponsor: Icahn School of Medicine at Mount Sinai (Other)
• Overall Status: Completed
• CT.gov ID: NCT01534416
• Collaborator: (none)
• Enrollment: 132
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 5.5

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effectiveness of placing numbing medication around the cervix prior to performing laparoscopic gynecologic surgery in decreasing pain after surgery. The study focuses on laparoscopic hysterectomies and robotic-assisted myomectomies. It will assess whether patients who receive the medication experience less pain and require less pain medication post operatively and if it helps reduce the number of patients who require hospitalization for pain control following surgery.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain; Paracervical Block; Laparoscopic Gynecologic Surgery	Drug: Bupivacaine; Drug: Normal Saline	N/A

Detailed Description

A variety of traditionally open surgical procedures have recently become minimally invasive through the use of laparoscopic technology. Gynecologic surgeries are no exception. However, some gynecologic laparoscopic procedures are associated with significant post-operative pain, necessitating prolonged hospitalization, use of post-operative opioids, and in some cases, the development of chronic post-operative pain. Prolonged hospitalization and use of opioids pose important patient safety concerns, such as increased risk of hospital borne illnesses and medication errors; in addition, opioids may cause respiratory depression and addiction. Given the rising cost of health care there is also an economic incentive to eliminate the need for hospital admission due to post-operative pain.

Preemptive analgesia involves nerve blockade or administration of pain medication systemically prior to incision to reduce post-procedure pain. Paracervical blockade is a form of preemptive analgesia. Paracervical blocks have been demonstrated to be safe and effective for obstetrical procedures in reducing post-operative pain since the 1970s. Recently they have also been shown to be efficacious for reducing post-operative pain in vaginal hysterectomy (Long et al, Int Urogynecol J (2009) 20:5-10).

For the present investigation, we intend to study the effectiveness of paracervical blockade for laparoscopic and robotic-assisted laparoscopic gynecological surgery. We hypothesize that paracervical blockade prior to surgical incision will lessen levels of post-operative pain, reduce use of opioids, and decrease the number of patients requiring hospitalization for pain control. We also hypothesize that the effects may be longer lasting than the immediate post-operative period and may decrease the amount of time to return to normal activity after surgery.

Using anecdotal evidence from the primary investigator, Dr. Ascher-Walsh the rate of hospitalization for laparoscopic hysterectomy (laparoscopic-assisted vaginal hysterectomy, total laparoscopic hysterectomy, laparoscopic assisted supracervical hysterectomy) is approximately 67%. In this study, we wish to decrease hospitalization with the paracervical block by 50%, thus obtaining an overall post-operative hospitalization rate of 33%. For robotic-assisted laparoscopic myomectomy, the rate of hospitalization is 50%. We wish to decrease this by 50% as well. Overall we are aiming to achieve a rate of 30% for post-operative hospitalization for pain control for laparoscopic hysterectomies and robotic myomectomies combined.

Study Design

• Study Type: Interventional
• Actual Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Use of Paracervical Block in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bupivacaine Subjects receive paracervical block with bupivacaine-epinephrine	Drug: Bupivacaine; Subjects are injected paracervically with 10 ml of 0.5% bupivacaine with 1:200000 units epinephrine prior to surgical incision.; Other Names: Marcaine
Placebo Comparator: Saline Subjects receive paracervical injection of normal saline	Drug: Normal Saline; Subjects are injected paracervically with 10 ml of normal saline prior to surgical incision.; Other Names: Saline

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Hospital Admission for Postoperative Pain Control [Four hours after conclusion of surgery]

   Unplanned hospital admissions and the hospital admissions at the request of the patients for pain management

Secondary Outcome Measures

1. Postoperative Pain Score [1and 2 hour postoperatively]

   Postoperative pain levels assessed using the visual analogue pain scale. This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain. In the PACU pain assessed using this scale by the nursing staff.

2. Postoperative Pain Score [1, 2, 4 hour postoperatively, Day 1 post operatively, Day 2 postoperative]

   Postoperative pain levels assessed using the visual analogue pain scale. This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain. In the PACU pain assessed using this scale by the nursing staff. On postoperative days 1 and 2 the subjects self-reported their pain level.

3. Postoperative Day Pain Medication Use [Postoperative days 0-10]

   Numbers of Patients Using Pain Medication on Postoperative Days 1-10. The subjects recorded at home the type and amount of pain medication they use for 10 days postoperatively.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Female

• Age 18 or older

• Scheduled for robotic-assisted laparoscopic myomectomy or laparoscopic hysterectomy, including total and supracervical hysterectomy, laparoscopic-assisted vaginal hysterectomy

• Surgery being performed for benign disease

Exclusion Criteria:

• Male

• Women under 18 years old

• Pregnancy

• Suspected or known malignant disease

• Immunocompromised

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

• Icahn School of Medicine at Mount Sinai

Investigators

• Principal Investigator: Charles Ascher-Walsh, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

• Long JB, Eiland RJ, Hentz JG, Mergens PA, Magtibay PM, Kho RM, Magrina JF, Cornella JL. Randomized trial of preemptive local analgesia in vaginal surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jan;20(1):5-10. doi: 10.1007/s00192-008-0716-6. Epub 2008 Oct 2.

• Responsible Party: Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT01534416
• Other Study ID Numbers: GCO 11-0021; HS# 11-00013
• First Posted: Feb 16, 2012
• Last Update Posted: Dec 20, 2017
• Last Verified: Dec 1, 2017

• Keywords provided by Icahn School of Medicine at Mount Sinai: Paracervical Block; Laparoscopic Surgery; Postoperative Pain; Bupivacaine; Hysterectomy; Myomectomy; Randomized Trial
• Additional relevant MeSH terms: Pain, Postoperative; Bupivacaine

Study Results

Participant Flow

Recruitment Details	Patients undergoing laparoscopic surgery for benign indications were enrolled between 2011 and 2013

Arm/Group Title	Bupivacaine	Saline
Arm/Group Description	Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision.	Subjects injected paracervically with 10 ml of normal saline prior to surgical incision.
Period Title: Overall Study
STARTED	68	64
COMPLETED	68	64
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Bupivacaine	Saline	Total
Arm/Group Description	Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision.	Subjects injected paracervically with 10 ml of normal saline prior to surgical incision.	Total of all reporting groups
Overall Participants	68	64	132
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.4 (9.2)	47.8 (9.3)	48.1 (9.2)
Sex: Female, Male (Count of Participants)
Female	68 100%	64 100%	132 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	36 52.9%	28 43.8%	64 48.5%
Black	12 17.6%	20 31.3%	32 24.2%
Hispanic	13 19.1%	10 15.6%	23 17.4%
Asian	4 5.9%	3 4.7%	7 5.3%
Other	2 2.9%	2 3.1%	4 3%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	27.2 (5.7)	29.1 (6.9)	28.1 (6.4)
Parity (Count of Participants)
0	21 30.9%	38 59.4%	59 44.7%
1	10 14.7%	10 15.6%	20 15.2%
2	22 32.4%	19 29.7%	41 31.1%
≥3	15 22.1%	11 17.2%	26 19.7%
Surgical Indication (Count of Participants)
Fibroids	7 10.3%	9 14.1%	16 12.1%
Bleeding	2 2.9%	1 1.6%	3 2.3%
Prolapse	14 20.6%	8 12.5%	22 16.7%
Pain	4 5.9%	1 1.6%	5 3.8%
Other	0 0%	3 4.7%	3 2.3%
Fibroids & bleeding	19 27.9%	14 21.9%	33 25%
Fibroids, bleeding & pain	18 26.5%	23 35.9%	41 31.1%
Bleeding & pain	4 5.9%	5 7.8%	9 6.8%
Uterine Size (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	13.7 (5.5)	14.2 (4.6)	14.0 (5.1)
Preoperative Hematocrit (% of cells) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [% of cells]	36.8 (4.0)	36.6 (4.2)	36.7 (4.1)
Admission Planned (admissions) [Number]
Number [admissions]	5	1	6

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Hospital Admission for Postoperative Pain Control
Description	Unplanned hospital admissions and the hospital admissions at the request of the patients for pain management
Time Frame	Four hours after conclusion of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine	Saline
Arm/Group Description	Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision.	Subjects injected paracervically with 10 ml of normal saline prior to surgical incision.
Measure Participants	68	64
Unplanned admission	23 33.8%	17 26.6%
Unplanned admission for pain	10 14.7%	11 17.2%

2. Secondary Outcome

Title	Postoperative Pain Score
Description	Postoperative pain levels assessed using the visual analogue pain scale. This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain. In the PACU pain assessed using this scale by the nursing staff.
Time Frame	1and 2 hour postoperatively

Outcome Measure Data

Analysis Population Description

This doesn't include hospitalization for reasons other than pain management.

Arm/Group Title	Bupivacaine	Bupivacaine Discharged	Saline Group	Saline Discharged Participants
Arm/Group Description	Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision and admitted for pain management. Participants who requested admission specifically for pain management.	Subjects who received bupivacaine and epinephrine and discharged home after surgery. Participants in the Bupivacaine arm who were not admitted.	Subjects injected paracervically with 10 ml of normal saline prior to surgical incision who were admitted for pain management. participants in the Saline arm who requested admission specifically for pain management.	Subjects who received saline and discharged after surgery. Participants in the Saline arm who were discharged after procedure and not admitted.
Measure Participants	10	40	11	46
1 hour postoperative	4.7 (2.9)	3.9 (2.2)	5.1 (2.0)	4.5 (2.4)
2 hours postoperative	4.3 (2.5)	2.7 (1.8)	4.5 (2.4)	3.8 (2.3)

3. Secondary Outcome

Title	Postoperative Pain Score
Description	Postoperative pain levels assessed using the visual analogue pain scale. This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain. In the PACU pain assessed using this scale by the nursing staff. On postoperative days 1 and 2 the subjects self-reported their pain level.
Time Frame	1, 2, 4 hour postoperatively, Day 1 post operatively, Day 2 postoperative

Outcome Measure Data

Analysis Population Description

Only those subjects with pain analyzed

Arm/Group Title	Bupivacaine	Saline Group
Arm/Group Description	Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision and admitted for pain management	Subjects injected paracervically with 10 ml of normal saline prior to surgical incision who were admitted for pain management
Measure Participants	64	59
1 hour postoperative	4.30 (2.55)	4.69 (2.29)
2 hours postoperative	3.37 (2.19)	4.01 (2.32)
4 hours postoperative	3.83 (2.57)	4.35 (2.43)
Day 1 postoperative	3.80 (2.53)	4.35 (2.14)
Day 2 postoperative	3.16 (2.34)	3.37 (2.39)

4. Secondary Outcome

Title	Postoperative Day Pain Medication Use
Description	Numbers of Patients Using Pain Medication on Postoperative Days 1-10. The subjects recorded at home the type and amount of pain medication they use for 10 days postoperatively.
Time Frame	Postoperative days 0-10

Outcome Measure Data

Analysis Population Description

missing data from 5 participants in Bupivacaine Arm and 4 in Saline Arm

Arm/Group Title	Bupivacaine Narcotics Use	Saline Narcotics Use	Bupivacaine OTC Analgesics Use	Saline OTC Analgesics Use
Arm/Group Description	OTC - over-the-counter
Measure Participants	63	60	63	60
Postoperative Day 1	52 76.5%	52 81.3%	17 12.9%	10 NaN
Postoperative Day 2	43 63.2%	39 60.9%	24 18.2%	18 NaN
Postoperative Day 3	28 41.2%	33 51.6%	29 22%	22 NaN
Postoperative Day 4	19 27.9%	26 40.6%	28 21.2%	26 NaN
Postoperative Day 5	13 19.1%	15 23.4%	19 14.4%	28 NaN
Postoperative Day 6	12 17.6%	13 20.3%	15 11.4%	24 NaN
Postoperative Day 7	5 7.4%	11 17.2%	16 12.1%	16 NaN
Postoperative Day 8	3 4.4%	10 15.6%	12 9.1%	12 NaN
Postoperative Day 9	2 2.9%	6 9.4%	9 6.8%	11 NaN
Postoperative Day 10	3 4.4%	7 10.9%	9 6.8%	10 NaN

Adverse Events

Time Frame	Complications were noted up to 6 weeks after surgery using the Clavien-Dindo Classification system.
Adverse Event Reporting Description	Grade I Any deviation from normal postoperative course without need for pharmacological treatment or surgical, endoscopic, & radiological interventions II Require pharmacological treatment with drug other than such allowed for Grade I complications III Require surgical, endoscopic or radiological intervention IIIa Intervention not under general anaesthesia IIIb Intervention under general anaesthesia IV Life-threatening complication IVa Single organ IVb Multiorgan V Death
Arm/Group Title	Bupivacaine		Saline
Arm/Group Description	Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision.		Subjects injected paracervically with 10 ml of normal saline prior to surgical incision.
All Cause Mortality
	Bupivacaine		Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/68 (0%)		0/64 (0%)
Serious Adverse Events
	Bupivacaine		Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/68 (1.5%)		0/64 (0%)
Renal and urinary disorders
Stress Incontinence	1/68 (1.5%)		0/64 (0%)
Other (Not Including Serious) Adverse Events
	Bupivacaine		Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/68 (25%)		16/64 (25%)
General disorders
Seizure	1/68 (1.5%)		0/64 (0%)
Emergency Room Visit	1/68 (1.5%)		0/64 (0%)
Injury, poisoning and procedural complications
Incisional Infection	4/68 (5.9%)		4/64 (6.3%)
Small Bowel Mesenteric Hematoma	0/68 (0%)		1/64 (1.6%)
Skin laceration	1/68 (1.5%)		0/64 (0%)
Retropubic hematoma	1/68 (1.5%)		1/64 (1.6%)
Bladder performation	1/68 (1.5%)		0/64 (0%)
Renal and urinary disorders
Urinary Tract Infection	0/68 (0%)		3/64 (4.7%)
Urinary Retention	6/68 (8.8%)		6/64 (9.4%)
Reproductive system and breast disorders
Cervical infection	2/68 (2.9%)		1/64 (1.6%)

Limitations/Caveats

[Not Specified]

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.