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

Comparison of Subcostal Exterior Semilunaris Transverses Abdomens, Modified Thoracoabdominal Nerves Block Through Perichondrial Approach, and Rectus Sheath Block in Patients Undergoing Major Abdominal Surgeries

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Bilateral SE-TAP; Procedure: Bilateral M-TAPA; Procedure: Bilateral RSB

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Eskisehir, Turkey, 26040
    • Eskisehir Osmangazi University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group SE-TAP block; 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; 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.; Other Names: Ultrasound guided bilateral subcostal exterior semilunaris transversus abdomens plane block
Active Comparator: Group M-TAPA block; 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; 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.; Other Names: Ultrasound guided bilateral modified thoracoabdominal nerves block through perichondrial approach (M-TAPA)
Active Comparator: Group RS block; 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; 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.; Other Names: Ultrasound guided bilateral rectus sheath block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Inonu University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Anticipated): February 28, 2024
• Study Completion (Anticipated): March 15, 2024

Study Registration Dates

• First Submitted: February 14, 2022
• First Submitted That Met QC Criteria: February 25, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: quality of recovery; postoperative pain; opioid consumption; abdominal surgery; fascial plane blocks
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: ESOGU anaesthesia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No