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

NCT ID: NCT04920994

Last Updated: 2022-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-13
• Study Completion Date: 2022-07-01

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.

Conditions

Abdominal Surgery

Study Design

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

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

M-TAPA block

Intervention Type: PROCEDURE

A high-frequency linear ultrasound probe will be used, probe will be placed on the costochondral angle in the sagittal plane and angled deeply to view the lower aspect of the chondrium in the midline, then using in-plane approach, a 22 Gauge Tuohy needle will be introduced into the lower aspect of the chondrium. The same procedure will be repeated on the contralateral side.

Bupivacaine Hydrochloride

Intervention Type: DRUG

20 ml 0.25% bupivacaine will be injected after the negative aspiration test.

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.

Group Type: ACTIVE_COMPARATOR

SCTAP block

Intervention Type: PROCEDURE

A high-frequency linear ultrasound probe will be placed obliquely on the upper abdominal wall, along the subcostal margin near the midline. After identifying the rectus abdominis muscle, the ultrasound probe will be gradually moved laterally along the subcostal margin until the transversus abdominis muscle will be identified lying posterior to the rectus muscle, then using in-plane approach, a 22 Gauge Tuohy needle will be introduced medially and directed towards the transversus abdominis plane until its tip reaches the fascia between the rectus abdominis and the transverse abdominis muscles on entering the neurofascial plane. The same procedure will be repeated on the contralateral side.

Bupivacaine Hydrochloride

Intervention Type: DRUG

20 ml 0.25% bupivacaine will be injected after the negative aspiration test.

Interventions

M-TAPA block

A high-frequency linear ultrasound probe will be used, probe will be placed on the costochondral angle in the sagittal plane and angled deeply to view the lower aspect of the chondrium in the midline, then using in-plane approach, a 22 Gauge Tuohy needle will be introduced into the lower aspect of the chondrium. The same procedure will be repeated on the contralateral side.

Intervention Type: PROCEDURE

SCTAP block

A high-frequency linear ultrasound probe will be placed obliquely on the upper abdominal wall, along the subcostal margin near the midline. After identifying the rectus abdominis muscle, the ultrasound probe will be gradually moved laterally along the subcostal margin until the transversus abdominis muscle will be identified lying posterior to the rectus muscle, then using in-plane approach, a 22 Gauge Tuohy needle will be introduced medially and directed towards the transversus abdominis plane until its tip reaches the fascia between the rectus abdominis and the transverse abdominis muscles on entering the neurofascial plane. The same procedure will be repeated on the contralateral side.

Intervention Type: PROCEDURE

Bupivacaine Hydrochloride

20 ml 0.25% bupivacaine will be injected after the negative aspiration test.

Intervention Type: DRUG

Other Intervention Names

Ultrasound guided block; Ultrasound guided block; Marcaine

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sameh Fathy

OTHER

Sponsor Role: lead

Responsible Party

Sameh Fathy

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

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sameh M El-Sherbiny, MD

Role: PRINCIPAL_INVESTIGATOR

Mansoura Faculty of Medicine

Locations

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

Modified TAPA Block

Identifier Type: -

Identifier Source: org_study_id