Skip to content

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

Continuous Preperitoneal Versus Epidural Infusion of Local Anesthetic for Enhanced Postoperative Recovery Following Open Colorectal Surgery

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00915265
Enrollment
100
Registered
2009-06-08
Start date
2009-10-31
Completion date
2018-10-31
Last updated
2018-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Rehabilitation After Surgery, Open Colorectal Surgery

Keywords

Epidural analgesia, Continuous preperitoneal analgesia, Surgery, Open colorectal surgery, Fast-track surgery, ERAS

Brief summary

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.

Detailed description

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.

Interventions

OTHERMultilobed 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

OTHERMultilobed catheter (group EA)

EA group : thoracic epidural infusion of 0.2 % ropivacaine

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
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)at 24 hour after tracheal extubation (H0)

Secondary

MeasureTime frame
Duration of Post-Anesthesia Care Unit (PACU) stayin the post-anesthesia care unit

Countries

France

Contacts

Primary ContactPatrick Lacarin
placarin@chu-clermontferrand.fr04.73.75.11.95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026