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
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2009
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2009
CompletedFirst Posted
Study publicly available on registry
June 8, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedJanuary 31, 2018
January 1, 2018
8.8 years
June 5, 2009
January 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Duration of Post-Anesthesia Care Unit (PACU) stay
in the post-anesthesia care unit
Interventions
\- 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
EA group : thoracic epidural infusion of 0.2 % ropivacaine
Eligibility Criteria
You may qualify if:
- Age \> 18 years
- Open colorectal surgery through a midline incision with a primary anastomosis
- American Society of Anesthesiologists (ASA) physical status I to III
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
Related Publications (1)
Jouve P, Bazin JE, Petit A, Minville V, Gerard A, Buc E, Dupre A, Kwiatkowski F, Constantin JM, Futier E. Epidural versus continuous preperitoneal analgesia during fast-track open colorectal surgery: a randomized controlled trial. Anesthesiology. 2013 Mar;118(3):622-30. doi: 10.1097/ALN.0b013e3182800d94.
PMID: 23426208DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Emmanuel FUTIER, MD
University Hospital, Clermont-Ferrand
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2009
First Posted
June 8, 2009
Study Start
October 1, 2009
Primary Completion
July 1, 2018
Study Completion
October 1, 2018
Last Updated
January 31, 2018
Record last verified: 2018-01