EVA: Epidural Analgesia (EDA) Versus Patient Controlled Analgesia (PCA) in Laparoscopic Colon Surgery

• Sponsor: University of Lausanne Hospitals (Other)
• Overall Status: Completed
• CT.gov ID: NCT00508300
• Collaborator: (none)
• Enrollment: 128
• Location: 1
• Arms: 2
• Duration (Months): 45
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether a epidural analgesia versus patient controlled analgesia reduces the medical recovery in patients undergoing elective laparoscopic colon surgery.

Condition or Disease	Intervention/Treatment	Phase
Laparoscopic Colectomy	Procedure: Epidural analgesia; Procedure: Patient controlled analgesia	N/A

Detailed Description

Allocation by individual random number generated by a computer program to either EDA or PCA for 48h after laparoscopic colonic surgery.

Short, both groups are treated according to a recent Fast track protocol. Group A will preoperatively receive a mid thoracic EDA (th 8-9; naropine 0,1%) while group B will receive a PCA (morphine) postoperatively. Both EDA and PCA are removed the afternoon at day 2. Patients with a non-functioning EDA within the first 24h will be crossed over to the PCA group.

Study Design

• Study Type: Interventional
• Actual Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Epidural Analgesia (EDA) Versus Patient Controlled Analgesia (PCA) in Laparoscopic Colon Surgery: A Monocentric Controlled Non-blinded Randomized Superiority Trial
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: A Epidural Analgesia (EDA) An epidural catheter was inserted at thoracic level (Th8-Th10) before induction of anesthesia. A bolus of 5 mL of bupivacaine 0.5% was started as soon as the epidural catheter was in place, and a continuous perfusion of bupivacaine 0.5% at 5 mL/hr was initiated until the end of surgical procedure.	Procedure: Epidural analgesia; Thoracic epidural analgesia until day 2
Other: B Patient controlled analgesia (PCA) was assured by fentanyl (morphine-based) as needed.	Procedure: Patient controlled analgesia; Patient controlled analgesia (morphine-based)

Outcome Measures

Primary Outcome Measures

1. Medical Recovery (Defined as Pain Sufficient Controlled by Oral Analgesia, Fully Mobile Patients or at Least as Mobile as at Admission and Tolerance of the Patient of Oral Food Intake (More Than 2/3 of Daily Meal)) [30 days]

   Medical recovery was chosen as primary end point and was defined as the fulfillment of all the 3 following criteria: (1) sufficient pain control by oral analgesics, (2) fully mobilized or at least comparable with preoperative status, and (3) tolerance of oral food that was defined as two thirds or more of normal meal (hospital portion).23 Medical recovery was considered as more specific outcome parameter than hospital stay because social and logistic factors were not interfering.24,25

Secondary Outcome Measures

1. Complication Rate, Peridural Analgesia Failure Rate, Patient Comfort [30 days]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• All patients admitted for elective laparoscopic colonic surgery

Exclusion Criteria:

• Age < 18y

• No informed consent

• Emergency situation

• Contraindication for EDA (according to local Anesthesia guidelines)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Visceral Surgery, University Hospital CHUV, Lausanne	Lausanne		Switzerland	1011

Sponsors and Collaborators

• University of Lausanne Hospitals

Investigators

• Study Chair: Nicolas Demartines, MD, Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nicolas DEMARTINES, professor of surgery, University of Lausanne Hospitals
• ClinicalTrials.gov Identifier: NCT00508300
• Other Study ID Numbers: P166/07
• First Posted: Jul 27, 2007
• Last Update Posted: Aug 11, 2020
• Last Verified: Jul 1, 2020

• Keywords provided by Nicolas DEMARTINES, professor of surgery, University of Lausanne Hospitals: laparoscopic; colectomy; Fast Track; epidural

Study Results

Participant Flow

Arm/Group Title	Epidural	Patient-controlled Analgesia
Arm/Group Description	Epidural Analgesia (Th 8-9) Epidural analgesia: Thoracic epidural analgesia until day 2	Patient controlled analgesia (morphine-based) Patient controlled analgesia: Patient controlled analgesia (morphine-based)
Period Title: Overall Study
STARTED	67	61
COMPLETED	65	57
NOT COMPLETED	2	4

Baseline Characteristics

Arm/Group Title	Epidural	Patient-controlled Analgesia	Total
Arm/Group Description	epidural catheter was inserted at thoracic level (Th8-Th10) before induction of anesthesia. A bolus of 5 mL of bupivacaine 0.5% was started as soon as the epidural catheter was in place, and a continuous perfusion of bupivacaine 0.5% at 5 mL/hr was initiated until the end of surgical procedure.	In the PCA group, intravenous PCA was inserted with 1 mg/h. A bolus of 1 mL was allowed at every 5 minutes up to a maximal dose of 40 mg/4h.	Total of all reporting groups
Overall Participants	65	57	122
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.1 (15.1)	61.2 (17.8)	62.5 (16.3)
Sex: Female, Male (Count of Participants)
Female	28 43.1%	23 40.4%	51 41.8%
Male	37 56.9%	34 59.6%	71 58.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Switzerland	65 100%	57 100%	122 100%

Outcome Measures

1. Primary Outcome

Title	Medical Recovery (Defined as Pain Sufficient Controlled by Oral Analgesia, Fully Mobile Patients or at Least as Mobile as at Admission and Tolerance of the Patient of Oral Food Intake (More Than 2/3 of Daily Meal))
Description	Medical recovery was chosen as primary end point and was defined as the fulfillment of all the 3 following criteria: (1) sufficient pain control by oral analgesics, (2) fully mobilized or at least comparable with preoperative status, and (3) tolerance of oral food that was defined as two thirds or more of normal meal (hospital portion).23 Medical recovery was considered as more specific outcome parameter than hospital stay because social and logistic factors were not interfering.24,25
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

accorindg to intention-to-treat principle

Arm/Group Title	Epidural	Patient-controlled Analgesia
Arm/Group Description	epidural catheter was inserted at thoracic level (Th8-Th10) before induction of anesthesia. A bolus of 5 mL of bupivacaine 0.5% was started as soon as the epidural catheter was in place, and a continuous perfusion of bupivacaine 0.5% at 5 mL/hr was initiated until the end of surgical procedure.	In the PCA group, intravenous PCA was inserted with 1 mg/h. A bolus of 1 mL was allowed at every 5 minutes up to a maximal dose of 40 mg/4h.
Measure Participants	65	57
Median (Inter-Quartile Range) [days]	5	4

2. Secondary Outcome

Title	Complication Rate, Peridural Analgesia Failure Rate, Patient Comfort
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Adverse event data were collected until 30 days after surgery.
Arm/Group Title	Epidural		Patient-controlled Analgesia
Arm/Group Description	epidural catheter was inserted at thoracic level (Th8-Th10) before induction of anesthesia. A bolus of 5 mL of bupivacaine 0.5% was started as soon as the epidural catheter was in place, and a continuous perfusion of bupivacaine 0.5% at 5 mL/hr was initiated until the end of surgical procedure.		In the PCA group, intravenous PCA was inserted with 1 mg/h. A bolus of 1 mL was allowed at every 5 minutes up to a maximal dose of 40 mg/4h.
All Cause Mortality
	Epidural		Patient-controlled Analgesia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/65 (3.1%)		0/57 (0%)
Serious Adverse Events
	Epidural		Patient-controlled Analgesia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/65 (20%)		5/57 (8.8%)
Surgical and medical procedures
major complications according to clavien: 3+4	13/65 (20%)	13	5/57 (8.8%)	5
Other (Not Including Serious) Adverse Events
	Epidural		Patient-controlled Analgesia
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/57 (0%)

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.