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NCT Number: NCT03971513

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

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

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Key information

Conditions

Surgery Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Stoma Ileostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU, Clermont-Ferrand, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trans abdominal plane

Procedure

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.

Primary outcomes

  1. Quo 40 score

    Time frame: Day 1 (

    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.

Secondary outcomes

  1. NRS (Numeric rating scale)

    Time frame: Day 1 : At the entrance of recovery room

    Numerating rating score variating from 0 to 10, done by nurses in operating room and in post operative surgical service

  2. NRS (Numeric rating scale)

    Time frame: Day 1

    Numerating rating score variating from 0 to 10, done by nurses in operating room and in post operative surgical service

  3. NRS (Numeric rating scale)

    Time frame: Day 2

    Numerating rating score variating from 0 to 10, done by nurses in operating room and in post operative surgical service

  4. Quo 40 score

    Time frame: Day 15

    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.

  5. Time spent in recovery room

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

    Assessment of time spent in recovery room (ie: entrance in recovery room until Aldrede score is >9) performed by nurses (Until 6 hours).

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: Tapas

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jun 3, 2019
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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