TAP Block Versus Conventional Systemic Analgesia

NCT ID: NCT06058715

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2024-10-31

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.

Detailed 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.

Conditions

Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TAP block

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.

Group Type: EXPERIMENTAL

Transverse Abdominal Plan block (TAP block)

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Transverse Abdominal Plan block (TAP block)

Intervention Type: 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.

Interventions

Transverse Abdominal Plan block (TAP block)

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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%

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Scientific Research, Tunisia

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sana Landolsi

Associate professor in general surgery, University Tunis El Manar, Faculty of medicine of Tunis, Department of surgery, Mahmoud El Matri hospital, Ariana, Tunisia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Aryanah, , Tunisia

Countries

Tunisia

Other Identifiers

TAP1-LAP2

Identifier Type: -

Identifier Source: org_study_id