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

Abdominal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04920994
• Other study ID #: Modified TAPA Block
• Status: Completed
• Phase: N/A
• Start date: August 13, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2022
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Surgery

Intervention

Procedure:
• 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.
• 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.

Drug:
• Bupivacaine Hydrochloride
20 ml 0.25% bupivacaine will be injected after the negative aspiration test.

Locations

Country	Name	City	State
Egypt	Department of Anesthesia, Mansoura University Hospitals	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Sameh Fathy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total analgesic requirements of morphine	The amount of morphine consumption in milligrams given as a rescue analgesia	Up to 24 hours after the procedure
Secondary	Improvement in pain scores by Visual analogue scale (VAS)	VAS score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) will be assessed postoperatively at 1, 2, 4, 8, 12, 24 hours	Up to 24 hours after the procedure
Secondary	Duration for the first analgesic request	The time of the first analgesic request for morphine in minutes will be recorded.	Up to 24 hours after the procedure
Secondary	Changes in heart rate	Heart rate (beat/min) will be recorded at baseline, intraoperative fifteen-minute intervals, 1, 2, 4, 8, 12, 24 hours postoperatively	Up to 24 hours after the procedure
Secondary	Changes in mean arterial blood pressure	Blood pressure (mmHg) will be recorded at baseline,intraoperative fifteen-minute intervals,1, 2, 4, 8, 12, 24 hours postoperatively	Up to 24 hours after the procedure
Secondary	Incidence of adverse effects	Any adverse effects like pneumothorax, respiratory depression, nausea, vomiting, pruritus, hematoma, or allergic reactions will be recorded.	Up to 24 hours after the procedure