Continuous Preperitoneal Infusion of Local Anesthetic (CPA) Versus Epidural Infusion of Local Anesthetic (EA) in Fast-Track Open Colorectal Surgery
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|ClinicalTrials.gov Identifier: NCT00915265|
Recruitment Status : Unknown
Verified January 2018 by University Hospital, Clermont-Ferrand.
Recruitment status was: Recruiting
First Posted : June 8, 2009
Last Update Posted : January 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Open Colorectal Surgery Early Rehabilitation After Surgery||Other: Multilobed catheter (group CPA) Other: Multilobed catheter (group EA)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Continuous Preperitoneal Versus Epidural Infusion of Local Anesthetic for Enhanced Postoperative Recovery Following Open Colorectal Surgery|
|Study Start Date :||October 2009|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||October 2018|
- Other: 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
- Other: Multilobed catheter (group EA)
EA group : thoracic epidural infusion of 0.2 % ropivacaine
- 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) ]
- Duration of Post-Anesthesia Care Unit (PACU) stay [ Time Frame: in the post-anesthesia care unit ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915265
|Contact: Patrick Lacarinemail@example.com|
|Clermont-Ferrand, France, 63003|
|Contact: Patrick Lacarin 0473751195 firstname.lastname@example.org|
|Principal Investigator:||Emmanuel FUTIER, MD||University Hospital, Clermont-Ferrand|