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Completed

NCT Number: NCT04920994

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

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.

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Key information

Conditions

Abdominal Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

m-TAPA block

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.

Other names: Ultrasound guided block

SCTAP block

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.

Other names: Ultrasound guided block

Bupivacaine Hydrochloride

Drug

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

Other names: Marcaine

Primary outcomes

  1. 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

  1. Improvement in pain scores by Visual analogue scale (VAS)

    Time frame: Up to 24 hours after the procedure

    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

  2. Duration for the first analgesic request

    Time frame: Up to 24 hours after the procedure

    The time of the first analgesic request for morphine in minutes will be recorded.

  3. Changes in heart rate

    Time frame: Up to 24 hours after the procedure

    Heart rate (beat/min) will be recorded at baseline, intraoperative fifteen-minute intervals, 1, 2, 4, 8, 12, 24 hours postoperatively

  4. Changes in mean arterial blood pressure

    Time frame: Up to 24 hours after the procedure

    Blood pressure (mmHg) will be recorded at baseline,intraoperative fifteen-minute intervals,1, 2, 4, 8, 12, 24 hours postoperatively

  5. Incidence of adverse effects

    Time frame: Up to 24 hours after the procedure

    Any adverse effects like pneumothorax, respiratory depression, nausea, vomiting, pruritus, hematoma, or allergic reactions will be recorded.

Sponsors and collaborators

Lead sponsor

Sameh Fathy

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 10, 2021
Registry last updated
Jul 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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