TAP Block Versus Conventional Systemic Analgesia

NCT06058715 | Unknown DMC

• 1 other identifier: TAP1-LAP2
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare TAP block to conventional systemic analgesia for postoperative pain management in patients undergoing elective laparoscopic cholecystectomy. As the adverse effects of pain management is related to size of opioid dose use, opioid consumption is chosen as the primary outcome and a decrease of at least 20% in the TAP block compared with the conventional systemic analgesia is considered to be clinically significant. Written informed consent has to obtained from all study patients. This trial is a prospective parallel group randomized superiority trial comparing TAP block to classic systemic analgesia in patients undergoing elective laparoscopic surgery in the department of surgery, Mahmoud El Matri Hospital, Ariana, with a 1:1 allocation ratio.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• Opioid consumption during the first 48 h postoperatively.

  Opioids are given only on request based on pain numerical rating scale (pain NRS) varying from 0 to10. For pain NRS \> 3 at rest or for pain NRS \> 5 on exercise, oxycodone is administrated intravenously at the recovery room at the dose of 0.05 mg/kg. Then, it is used intramuscularly at the dose of 0.1 mg/kg up to 24 hours after surgery and orally at the dose of 0.15 mg/kg between 24 and 48 hours after surgery. At 2 to 4 weeks postoperatively, all patients are contacted either by phone or at the outpatient clinic during a follow-up visit and asked to complete a form with questions evaluating pain sensations, pain intensity, need for pain medication, performance of daily activities, and any limitations of these due to postoperative abdominal pain.

  Every six hours

Secondary Outcomes (2)

• Pain intensity on a numerical rating scale (pain NRS, 0-10)

  Every six hours

• Postoperative evaluation at 4 weeks

  At 4 weeks after surgery

Study Arms (2)

TAP block

EXPERIMENTAL

Bilateral TAP block is administered intraoperatively at laparoscopy, directly after insufflation and insertion of the first trocar and camera. The ultrasound probe is placed longitudinally on the midaxillary line near umbilicus, and the transversus abdominis and internal oblique muscles are scanned and observed. The needle (22-gauge 90 mm disposable spinal needle) is inserted in plane. After placing the needle-tip into the fascia between transversus abdominis and internal oblique muscles, Ropivacaine 0.25% (Naropin) is injected bilaterally at the dose of 0.5 mg/kg. It is all done by one Anesthetist which is expert in that area and is not in charge of collecting the data. No additional regional anesthesia, including epidural or spinal anesthesia, is given. The patients are mobilized in the recovery room 2 h after surgery.

Procedure: Transverse Abdominal Plan block (TAP block)

Conventional analgesia

ACTIVE COMPARATOR

No additional regional anesthesia, including epidural or spinal anesthesia, is given. For postoperative analgesia, all patients receive paracetamol intravenously at the dose of 1 g three times up to 24 hours, starting immediately after surgery. Complementary opioids are given on request when pain numerical rating scale (pain NRS) : NRS \> 3 at rest or for pain NRS \> 5 on exercise. Oxycodone is given intravenously at the dose of 0.05 mg/kg only in the recovery room up to two hours after the surgery. It is administrated intramuscularly at the dose of 0.1 mg/kg up to 24 hours after surgery. Then, it is given orally at the dose of 0.2 mg/kg from 24 to 48 hours after surgery.

Procedure: Transverse Abdominal Plan block (TAP block)

Interventions

Transverse Abdominal Plan block (TAP block) PROCEDURE

Bilateral TAP block is administered intraoperatively at laparoscopy, directly after insufflation and insertion of the first trocar and camera. The ultrasound probe is placed longitudinally on the midaxillary line near umbilicus, and the transversus abdominis and internal oblique muscles are scanned and observed. The needle (22-gauge 90 mm disposable spinal needle) is inserted in plane and after placing the needle-tip into the fascia between transversus abdominis and internal oblique muscles, 20 ml of ropivacaine 0.25% is injected bilaterally. It is all done by one Anesthetist which is expert in that area and is not in charge of collecting the data.

Conventional analgesia; TAP block

Eligibility Criteria

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

You may qualify if:

• All patients scheduled for elective laparoscopic cholecystectomy at the department of surgery, Mahmoud El Matri Hospital, Ariana

You may not qualify if:

• Severe renal insufficiency (GFR \< 30 ml/min)
• Severe hepatic insufficiency (TT ≤ 50%)
• Severe COPD (FEV1 \> 30%)
• Metastatic malignancy
• Hematologic disease or a congenital clotting disorder
• Preoperative opioid use
• Age under 18 years
• Pregnancy or breast-feeding
• Hyper-reactivity toward ropivacaine
• Estimated risk for conversion to open surgery \> 50%

Sponsors & Collaborators

• Ministry of Scientific Research, Tunisia: lead

Study Sites (1)

Department of surgery, Mahmoud El Matri hospital, Ariana, Tunisia

Aryanah, Tunisia

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor in general surgery, University Tunis El Manar, Faculty of medicine of Tunis, Department of surgery, Mahmoud El Matri hospital, Ariana, Tunisia

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: September 28, 2023
• Study Start: September 15, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)