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Clinical Trials/NCT04920994
NCT04920994
Completed
N/A

Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) in Comparison to Subcostal Transverse Abdominis Plane Block (TAP) in Major Abdominal Surgeries

Sameh Fathy1 site in 1 country80 target enrollmentAugust 13, 2021

Overview

Phase
N/A
Intervention
M-TAPA block
Conditions
Abdominal Surgery
Sponsor
Sameh Fathy
Enrollment
80
Locations
1
Primary Endpoint
Total analgesic requirements of morphine
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This study will be conducted to evaluate efficacy of ultrasound guided modified thoracoabdominal nerves block via a new perichondrial approach (M-TAPA) for postoperative analgesia in major abdominal surgeries in comparison to subcostal transverse abdominis plane (SCTAP) block.

It is hypothesized that M-TAPA block will be advantageous to SCTAP block as a promising effective alternative for analgesia for major abdominal surgeries with fewer side effects.

Detailed Description

Postoperative pain management for major abdominal surgeries can reduce postoperative respiratory dysfunction and promote early mobilization. Traditionally, opioids have been used to manage postoperative pain. However, an increasing awareness of opioid-related adverse events including respiratory depression, paralytic ileus, and sedation, has led to a shift towards utilizing opioid-sparing techniques for postoperative analgesia. As such, outcomes associated with the transverse abdominis plane block are of increasing interest. A modified thoracoabdominal nerves block via a new perichondrial approach (M-TAPA) is a novel analgesic technique that involves local anesthetic injection into the lower aspect of the chondrium. It can block thoracoabdominal nerves at T5 in cephalic direction and down to T11-T12 in caudal direction and may be an effective analgesic for major abdominal surgeries. The aim of this study is to assess the quality of pain relief in patients who will undergo major abdominal surgery receiving either (M-TAPA) block or (SCTAP) block by comparing and evaluating the differences between the two techniques. This prospective, randomized, comparative clinical study will include 80 patients who will be scheduled for major abdominal surgery under general anesthesia in Mansoura university hospitals. Informed written consent will be obtained from all subjects in the study after ensuring confidentiality. Eligible patients will be randomly assigned to 2 equal groups (M-TAPA group and SCTAP group) according to computer-generated table of random numbers using the permuted block randomization method. The collected data will be coded, processed, and analyzed using SPSS program. All data will be considered statistically significant if P value is ≤ 0.05.

Registry
clinicaltrials.gov
Start Date
August 13, 2021
End Date
July 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Sameh Fathy

Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Mansoura University

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiology (ASA) I and II patients.
  • Scheduled for elective major abdominal surgeries.

Exclusion Criteria

  • Patient's refusal.
  • Altered mental status or un-cooperative patients.
  • History of known sensitivity to the used anesthetics.
  • Bleeding or coagulation diathesis.
  • Infection at the injection site.

Arms & Interventions

Group A (M-TAPA )

Ultrasound-guided M-TAPA block will be performed under strict aseptic conditions with the patient in the supine position, and bupivacaine will be administered.

Intervention: M-TAPA block

Group A (M-TAPA )

Ultrasound-guided M-TAPA block will be performed under strict aseptic conditions with the patient in the supine position, and bupivacaine will be administered.

Intervention: Bupivacaine Hydrochloride

Group B (SCTAP)

Ultrasound-guided SCTAP block will be performed under strict aseptic conditions with the patient in the supine position, and bupivacaine will be administered.

Intervention: SCTAP block

Group B (SCTAP)

Ultrasound-guided SCTAP block will be performed under strict aseptic conditions with the patient in the supine position, and bupivacaine will be administered.

Intervention: Bupivacaine Hydrochloride

Outcomes

Primary Outcomes

Total analgesic requirements of morphine

Time Frame: Up to 24 hours after the procedure

The amount of morphine consumption in milligrams given as a rescue analgesia

Secondary Outcomes

  • Duration for the first analgesic request(Up to 24 hours after the procedure)
  • Improvement in pain scores by Visual analogue scale (VAS)(Up to 24 hours after the procedure)
  • Changes in heart rate(Up to 24 hours after the procedure)
  • Changes in mean arterial blood pressure(Up to 24 hours after the procedure)
  • Incidence of adverse effects(Up to 24 hours after the procedure)

Study Sites (1)

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