Continuous Preperitoneal Infusion of Local Anesthetic (CPA) Versus Epidural Infusion of Local Anesthetic (EA) in Fast-Track Open Colorectal Surgery
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Open Colorectal Surgery Early Rehabilitation After Surgery |
Other: Multilobed catheter (group CPA) Other: Multilobed catheter (group EA) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Continuous Preperitoneal Versus Epidural Infusion of Local Anesthetic for Enhanced Postoperative Recovery Following Open Colorectal Surgery |
- Pain measured at mobilization (defined as pain experienced during transition from supine to the sitting position) using the visual analogue pain scale (VAS) from 0 (no pain) to 10 (worst pain imaginable), at 24 hour after tracheal extubation (H0) [ Time Frame: at 24 hour after tracheal extubation (H0) ] [ Designated as safety issue: Yes ]
- Duration of Post-Anesthesia Care Unit (PACU) stay [ Time Frame: in the post-anesthesia care unit ] [ Designated as safety issue: Yes ]
| Enrollment: | 100 |
| Study Start Date: | October 2009 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
-
Other: Multilobed catheter (group CPA)
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| France | |
| CHU Clermont-Ferrand | |
| Clermont-Ferrand, France, 63003 | |
| Principal Investigator: | Emmanuel FUTIER, MD | University Hospital, Clermont-Ferrand |
More Information
No publications provided by University Hospital, Clermont-Ferrand
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Hospital, Clermont-Ferrand |
| ClinicalTrials.gov Identifier: | NCT00915265 History of Changes |
| Other Study ID Numbers: | CHU-0052 |
| Study First Received: | June 5, 2009 |
| Last Updated: | May 15, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Clermont-Ferrand:
|
Epidural analgesia Continuous preperitoneal analgesia Surgery |
Open colorectal surgery Fast-track surgery ERAS |
Additional relevant MeSH terms:
|
Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013