Trans Abdominal Plane Block (TAP Block) in Surgery of Stoma Reversal and Its Effect on Post Operative Recovery: a Prospective, Randomized, Muticenter Study

NCT03971513 | Completed

• 2 other identifiers: RBHP 2019 VIGNAUD - Tapas2019-001022-95
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 2

Brief Summary

The primary purpose of TAPAS study is to demonstrate the superiority of analgesic effect of trans abdominal plane block (TAP block) performed at the beginning of stoma reversal, compared to standard of care. The hypothesize is that a TAP block performed at the beginning of surgery of stoma reversal would improve patient's satisfaction (evaluated by Quo-r40 questionnaire), would reduce the incidence of post operative pain, time spent in recovery room, and reduce hospitalisation time

Conditions

Surgery; Stoma Ileostomy

Keywords

Prospective randomized pilot study; Trans abdominal plane block; Quo R 40 score; Post operative pain

Outcome Measures

Primary Outcomes (1)

• Quo 40 score

  Once the patient is transferred in post operative surgical service, assessment of the primary outcome will be done by the physician in charge of the patient. Quo 40 score is a postoperative recovery score above 200 points validated by Myles et al in 2001.

  Day 1 (

Secondary Outcomes (5)

• NRS (Numeric rating scale)

  Day 1 : At the entrance of recovery room

• NRS (Numeric rating scale)

  Day 1

• NRS (Numeric rating scale)

  Day 2

• Quo 40 score

  Day 15

• Time spent in recovery room

  At the output of recovery room ie until 6 hours after intervention

Study Arms (2)

usual practice

NO INTERVENTION

Control group (usual practice): patients receiving a general anaesthesia with propofol, sufentanyl and cisatracurium for the induction, and sevoflurane, sufentanyl and cisatracurium for the maintenance. Patients receiving a multimodal intravenous analgesia, with acetaminophen, ketoprophen, nefopam and morphine. if necessary. Antimicrobial prophylaxis is performed according to recommendations

TAP block

EXPERIMENTAL

In addition of usual practice, patients receiving a TAP block at the beginning of the surgery

Procedure: Trans abdominal plane

Interventions

Trans abdominal plane PROCEDURE

Trans abdominal plane block is performed with ultra sound guidance. 1. \- The high frequency probe is placed right to the umbilicus, and slips laterally to the side to block. It allows showing the three belts of larges muscles of abdomen (External Oblicum, internal oblicum, and transversal of the abdomen). 2. \- When the needle is visualised in the plan separating the muscle internal oblicum and transversal of the abdomen, 20 ml of ropivacaïne 5mg/ml are injected after aspiration test. If in doubt, hydro localisation car be realised.

TAP block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old
• Patients operated of a scheduled stoma reversal surgery
• Patients having given consent in the mannen described in Article L1122-1-1 of the Public Health Code
• Patients affiliated with asocial security regimen or beneficiary of such a regimen

You may not qualify if:

• Renal insufficiency (ie glomerular filtration output \< 35 ml/min)
• Patients with chronic inflammatory bowel disease
• Body mass index \> 35 kg/m2
• Chronic pain with opiates
• Patients with cognitive troubles
• Coagulation disorders (platelets count \< 80G/L, PT\< 50%, V factor \< 50%)
• Pregnancy
• Breastfeeding
• Local anesthesics (amide class) allergy

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (2)

CHU

Clermont-Ferrand, France

Location

CHU Rennes

Rennes, 35033, France

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Marie Vignaud

  CHU Clermont-Ferrand.fr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Model description: Randomization in 2 groups * Control group (usual practice): patients receiving a general anaesthesia with propofol, sufentanyl and cisatracurium for the induction, and sevoflurane, sufentanyl and cisatracurium for the maintenance. Patients receiving a multimodal intravenous analgesia, with acetaminophen, ketoprophen, nefopam and morphine if necessary Antimicrobial prophylaxis is performed according to recommendations. * Experimental group: patients receiving a general anaesthesia with propofol, sufentanyl and cisatracurium for the induction, and sevoflurane, sufentanyl and cisatracurium for the maintenance. Patients receiving a multimodal intravenous analgesia, with acetaminophen, ketoprophen, nefopan and morphine if necessary Antimicrobial prophylaxis is performed according to recommendations. In this group, a trans abdominal plane block, using 20 ml of ropivacaine 5 mg/ml is performed at the beginning of surgery, using ultrasound guidance.

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: June 3, 2019
• Study Start: June 17, 2019
• Primary Completion: April 17, 2023
• Study Completion: April 17, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

FR (2)