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

Not Applicable

• Conditions: Postoperative Pain
• Interventions: Procedure: Bilateral SE-TAP; Procedure: Bilateral M-TAPA; Procedure: Bilateral RSB

• Registration Number: NCT05259345
• Lead Sponsor: Inonu University

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.

Detailed Description

In last decade,ultrasound guided truncal fascial plane blocks such as transverses abdominis plane (TAP) block and rectus sheath block (RSB) have become popular as a part of postoperative multimodal analgesia for abdominal surgeries as the techniques are simple and the target sites are easily identify. Furthermore, the number of newly defined block techniques is daily increasing like M-TAPA and SE-TAP block.

The rectus sheath block (RSB) is an old technique that suite midline incisions and provides analgesia for somatic pain. The local anesthetic is injected into the space between the posterior wall of the rectus abdominis muscle and its sheath, to block the anterior branches of the thoracoabdominal nerves. It has been suggested that both anterior and lateral branches of the T5-T12 thoracoabdominal nerves are blockade in M-TAPA and SE-TAP blocks. So, they may provide better analgesia and quality of recovery for major abdominal surgeries due to presence of drains. However, the extent of the local anaesthetic diffusion and the dermatomal levels are not clear, and there is no randomised clinical trial about these new techniques, to our knowledge.

Patients and Methods: This is a prospective, randomised, double-blind clinical study; carry out on 120 patients schedule for elective major abdominal surgery with midline incision. While the fascia is closed, 1 g paracetamol and 1 mg/kg tramadol will be administered routinely to all patients for postoperative multimodal analgesia. At the end of surgery, patients will be randomly allocated into three groups (40 patients each); bilateral SE-TAP block in Group S, bilateral RSB in Group R, and bilateral M-TAPA block in Group M will be performed under ultrasound guidance. Patient controlled analgesia with intravenous morphine will be started at the recovery room. Postoperative pain levels, opioid consumption, and quality of recovery will be questioned and recorded at the first postoperative day.

Study Timeline

• Study First Submitted: 2022-02-14
• Study First Submitted QC: 2022-02-25
• Study Start: 2022-02-28
• Study First Posted: 2022-02-28
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-07
• Primary Completion: 2024-02-28
• Study Completion: 2024-03-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group SE-TAP block	Bilateral SE-TAP	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)
Group M-TAPA block	Bilateral M-TAPA	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)
Group RS block	Bilateral RSB	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)

Primary Outcome Measures

Name	Time	Method
Quality of Recovery	At postoperative 24th hours	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).

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	At postoperative 48 hours (2.,6.,12.,18.,24.,48.hours)	Numeric rating scale pain from 0 (no pain) to 10 (worst pain).
Opioid consumption	At postoperative 48 hours (2.,6.,12.,18.,24.,48.hours)	Morphine consumption

Trial Locations

Locations (1)

Eskisehir Osmangazi University Faculty of Medicine; 🇹🇷 Eskisehir, Turkey