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

NCT ID: NCT00508300

Last Updated: 2020-08-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Laparoscopic Colectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type OTHER

Epidural analgesia

Intervention Type PROCEDURE

Thoracic epidural analgesia until day 2

B

Patient controlled analgesia (PCA) was assured by fentanyl (morphine-based) as needed.

Group Type OTHER

Patient controlled analgesia

Intervention Type PROCEDURE

Patient controlled analgesia (morphine-based)

Interventions

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Epidural analgesia

Thoracic epidural analgesia until day 2

Intervention Type PROCEDURE

Patient controlled analgesia

Patient controlled analgesia (morphine-based)

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lausanne Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Nicolas DEMARTINES

professor of surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicolas Demartines, MD

Role: STUDY_CHAIR

Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland

Locations

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Department of Visceral Surgery, University Hospital CHUV, Lausanne

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

References

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Hubner M, Blanc C, Roulin D, Winiker M, Gander S, Demartines N. Randomized clinical trial on epidural versus patient-controlled analgesia for laparoscopic colorectal surgery within an enhanced recovery pathway. Ann Surg. 2015 Apr;261(4):648-53. doi: 10.1097/SLA.0000000000000838.

Reference Type DERIVED
PMID: 25119117 (View on PubMed)

Other Identifiers

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P166/07

Identifier Type: -

Identifier Source: org_study_id

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