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

Surgery Clinical Trial

— Tapas  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03971513
• Other study ID #: RBHP 2019 VIGNAUD - Tapas
• Secondary ID: 2019-001022-95
• Status: Completed
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: April 17, 2023

Study information

• Verified date: April 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

The patient will arrive in the department the day before the surgical intervention (D-1). During this preoperative visit (D-1), the investigator

• will preselect potentially eligible patients

• will offer to participate to this study

• will give the notice form to the patients

• will present the research: objectives, benefits and constraints for the patients

The intervention day (D0):

The investigator will collect the signed consent form after having ascertained the understanding of the notice form by the patient and checking the inclusion and non-inclusion criteria.

The randomization will be done via the eCRF module (allocation group and number) and the preoperative data registration in the eCRF.

Surgical Intervention (D1):

All patients will receive standard anaesthesia using sufentanyl, propopol, cisatracurium and sevoflurane. Prevention of nausea and vomiting is performing using Apfel score. Anti microbial prophylaxis is performed according recommendations.

All patients will receive post operative multimodal analgesia using, acetaminophene, ketaminophene (if no contra indication), nefopam, and morphine if NRS (numerating rating scale) > 3 At the end of the surgery, patients in the experimental group will receive a ultrasound guided trans abdominal plane block with 20 ml of 5 mg/mg of ropivacaine. Patients in the control group will not receive the block

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: April 17, 2023
• Est. primary completion date: April 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Stoma Ileostomy
• Surgery

Intervention

Procedure:
• Trans abdominal plane
Trans abdominal plane block is performed with ultra sound guidance. - 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). - 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.

Locations

Country	Name	City	State
France	CHU	Clermont-Ferrand
France	CHU Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	NRS (Numeric rating scale)	Numerating rating score variating from 0 to 10, done by nurses in operating room and in post operative surgical service	Day 1 : At the entrance of recovery room
Secondary	NRS (Numeric rating scale)	Numerating rating score variating from 0 to 10, done by nurses in operating room and in post operative surgical service	Day 1
Secondary	NRS (Numeric rating scale)	Numerating rating score variating from 0 to 10, done by nurses in operating room and in post operative surgical service	Day 2
Secondary	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 15
Secondary	Time spent in recovery room	Assessment of time spent in recovery room (ie: entrance in recovery room until Aldrede score is >9) performed by nurses (Until 6 hours).	At the output of recovery room ie until 6 hours after intervention