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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05259345
• Other study ID #: ESOGU anaesthesia
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 28, 2022
• Est. completion date: March 15, 2024

Study information

• Verified date: April 2023
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: March 15, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Eskisehir Osmangazi University Faculty of Medicine	Eskisehir

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Opioid consumption	Morphine consumption	At postoperative 48 hours (2.,6.,12.,18.,24.,48.hours)