Comparison of SE-TAP, M-TAPA, and Rectus Sheath Block in Abdominal Surgeries

NCT05259345 | Unknown

• 1 other identifier: ESOGU anaesthesia
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomised controlled study is to compare the effects of three different fascial plane block \[subcostal exterior semilunaris transverses abdominis plane (SE-TAP) block, modified thoracoabdominal nerves block through perichondrial approach (M-TAPA), and rectus sheath block (RSB)\] on postoperative pain levels and opioid consumption in patients undergoing major abdominal surgeries with midline incision.

Conditions

Postoperative Pain

Keywords

fascial plane blocks; postoperative pain; opioid consumption; quality of recovery; abdominal surgery

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery

  Quality of Recovery-40 (QoR-40), a 40-item questionnaire that provides a global score and subscores across five dimensions; patient support, comfort, emotions, physical independence, and pain (minimum score of 40 and maximum of 200).

  At postoperative 24th hours

Secondary Outcomes (2)

• Postoperative pain

  At postoperative 48 hours (2.,6.,12.,18.,24.,48.hours)

• Opioid consumption

  At postoperative 48 hours (2.,6.,12.,18.,24.,48.hours)

Study Arms (3)

Group SE-TAP block

ACTIVE COMPARATOR

Bilateral subcostal exterior semilunaris transverses abdominis plane (SE-TAP) block will be performed with 20 mL of local anesthetic solution (10 mL of 5% bupivacaine + 5 mL of 2% lidocaine + 5 mL of saline)

Procedure: Bilateral SE-TAP

Group M-TAPA block

ACTIVE COMPARATOR

Bilateral modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) will be performed with 20 mL of local anesthetic solution (10 mL of 5% bupivacaine + 5 mL of 2% lidocaine + 5 mL of saline)

Procedure: Bilateral M-TAPA

Group RS block

ACTIVE COMPARATOR

Bilateral rectus sheath block will be performed with 20 mL of local anesthetic solution (10 mL of 5% bupivacaine + 5 mL of 2% lidocaine + 5 mL of saline)

Procedure: Bilateral RSB

Interventions

Bilateral SE-TAP PROCEDURE

A 20 mL of local anesthetic solution (10 mL of 5% bupivacaine + 5 mL of 2% lidocaine + 5 mL of saline) will be given between the internal oblique and transversus abdominis muscles toward the lateral border of the semilunar along the costal margin.

Also known as: Ultrasound guided bilateral subcostal exterior semilunaris transversus abdomens plane block

Group SE-TAP block

Bilateral M-TAPA PROCEDURE

A 20 mL of local anesthetic solution (10 mL of 5% bupivacaine + 5 mL of 2% lidocaine + 5 mL of saline) will be given into the layer between the transverse abdominal muscle and the inferior plane of the costal cartilage at the midclavicular line, in the sagittal plane.

Also known as: Ultrasound guided bilateral modified thoracoabdominal nerves block through perichondrial approach (M-TAPA)

Group M-TAPA block

Bilateral RSB PROCEDURE

A 20 mL of local anesthetic solution (10 mL of 5% bupivacaine + 5 mL of 2% lidocaine + 5 mL of saline) will be given between the rectus muscle and posterior rectus sheath bilaterally.

Also known as: Ultrasound guided bilateral rectus sheath block

Group RS block

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiology physical classification I-III
• Scheduled for elective laparotomy with a midline incision

You may not qualify if:

• Not agree to participate in the study
• Have mental status disorders
• Inability to communicate
• Known bleeding and/or coagulation disorders
• Infection at injection site
• Chronic opioid intake

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Eskisehir Osmangazi University Faculty of Medicine

Eskişehir, 26040, Turkey (Türkiye)

Location

Related Publications (1)

• Bakshi SG, Mapari A, Shylasree TS. REctus Sheath block for postoperative analgesia in gynecological ONcology Surgery (RESONS): a randomized-controlled trial. Can J Anaesth. 2016 Dec;63(12):1335-1344. doi: 10.1007/s12630-016-0732-9. Epub 2016 Sep 14.

  PMID: 27638294 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Gulay Erdogan Kayhan, Professor

  Eskisehir Osmangazi University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 28, 2022
• Study Start: February 28, 2022
• Primary Completion: February 28, 2024
• Study Completion: March 15, 2024
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)