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Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) in Major Abdominal Surgeries

S

Sameh Fathy

Status

Completed

Conditions

Abdominal Surgery

Treatments

Drug: Bupivacaine Hydrochloride
Procedure: SCTAP block
Procedure: M-TAPA block

Study type

Interventional

Funder types

Other

Identifiers

NCT04920994
Modified TAPA Block

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups

Group A (M-TAPA )
Active Comparator group
Description:
Ultrasound-guided M-TAPA block will be performed under strict aseptic conditions with the patient in the supine position, and bupivacaine will be administered.
Treatment:
Procedure: M-TAPA block
Drug: Bupivacaine Hydrochloride
Group B (SCTAP)
Active Comparator group
Description:
Ultrasound-guided SCTAP block will be performed under strict aseptic conditions with the patient in the supine position, and bupivacaine will be administered.
Treatment:
Drug: Bupivacaine Hydrochloride
Procedure: SCTAP block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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