TAP Block Versus Conventional Systemic Analgesia (TAPLAP)

Ministry of Scientific Research, Tunisia

Status: Active, not recruiting

Conditions: Analgesia

Treatments: Procedure: Transverse Abdominal Plan block (TAP block)

Study type: Interventional

Funder types: Other

Identifiers

NCT06058715

TAP1-LAP2

Details and patient eligibility

About

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.

Full description

Laparoscopic cholecystectomy constitutes a routinely performed procedure world-wide. Analgesia accounts for one of the major keys for success especially in enhanced recovery after surgery pathway and ambulatory surgery. Hence, controlling opioid consumption used in conventional systemic analgesia is mandatory while reliving pain. The TAP block is integrated within a multimodal analgesia. It corresponds to a locoregional analgesia.

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.

Enrollment: 380 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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380 participants in 2 patient groups

TAP block

Experimental group

Description:

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.

Treatment:

Procedure: Transverse Abdominal Plan block (TAP block)

Conventional analgesia

Active Comparator group

Description:

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.

Treatment:

Procedure: Transverse Abdominal Plan block (TAP block)