Continuous Preperitoneal Infusion of Local Anesthetic (CPA) Versus Epidural Infusion of Local Anesthetic (EA) in Fast-Track Open Colorectal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2018-10-31

Brief Summary

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The purpose of this study is to compare the continuous preperitoneal infusion of local anesthetic and continuous epidural analgesia for postoperative pain management in fast-track open colorectal surgery.

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Detailed Description

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Optimized pain relief allowing early mobilization is a prerequisite for enhanced recovery after surgery. Open colorectal surgery is associated with severe and prolonged postoperative pain, especially during mobilization. No analgesic technique has fulfilled all requirements of optimal efficacy: no side effects, low costs, high patient compliance, and improvement in outcome, and consequently, multimodal analgesic techniques have been introduced with a focus on opioid sparing to improve analgesia and recovery. Epidural analgesia (EA) has shown a marked benefit in controlling pain at mobilization, and significantly improves pain management when compared with systemic patient-controlled morphine analgesia. However, eligible patients may not benefit from it because of technical problems or failure of efficiency. Recently, continuous preperitoneal infusion of local anesthetic (CPA) has been shown to be an effective method to relief pain after open colorectal surgery, to reduced morphine consumption and accelerated postoperative recovery. However, this technique has never been evaluated in a fast-track program (ERAS protocol). Moreover, continuous preperitoneal infusions of local anesthetic and epidural analgesia have never been compared.

The purpose of this randomized and double-blinded study is to compare these two techniques on pain control during mobilization, as a prerequisite for enhanced recovery after open colorectal surgery: 1- CPA group: continuous preperitoneal administration of 0.2% ropivacaine using a multilobed catheter positioned between the previously closed parietal peritoneum and the underside of the transversalis fascia + intravenous morphine (patient-controlled analgesia, PCA) as a rescue; 2- EA group: epidural infusion of 0.2% ropivacaine (patient-controlled epidural analgesia, PCEA) + continuous preperitoneal administration of 0.9% saline.

Conditions

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Open Colorectal Surgery Early Rehabilitation After Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Multilobed catheter (group CPA)

\- CPA group: continuous preperitoneal administration of 0.2% ropivacaine using a multilobed catheter positioned between the previously closed parietal peritoneum and the underside of the transversalis fascia

Intervention Type OTHER

Multilobed catheter (group EA)

EA group : thoracic epidural infusion of 0.2 % ropivacaine

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Open colorectal surgery through a midline incision with a primary anastomosis
* American Society of Anesthesiologists (ASA) physical status I to III

Exclusion Criteria

* Obesity (body mass index \> 35 kg/m2)
* Pregnancy
* Inflammatory bowel diseases
* Contraindication for epidural analgesia (patient refusal, active sepsis, coagulopathy)
* Chronic renal failure (with creatinin clearance \< 30 ml/min)
* Significant hepatic failure (prothrombin ratio \< 50%, factor V \< 50%)
* Chronic pain
* Preoperative opioid consumption
* Preoperative cognitive dysfunction
* Preoperative psychiatric disorders

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No