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

Primary Purpose

Postoperative Pain

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bilateral SE-TAP
Bilateral M-TAPA
Bilateral RSB
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring fascial plane blocks, postoperative pain, opioid consumption, quality of recovery, abdominal surgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eskisehir Osmangazi University Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group SE-TAP block

Group M-TAPA block

Group RS block

Arm Description

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)

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)

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)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Postoperative pain
Numeric rating scale pain from 0 (no pain) to 10 (worst pain).
Opioid consumption
Morphine consumption

Full Information

First Posted
February 14, 2022
Last Updated
April 6, 2023
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT05259345
Brief Title
Comparison of SE-TAP, M-TAPA, and Rectus Sheath Block in Abdominal Surgeries
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
March 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
fascial plane blocks, postoperative pain, opioid consumption, quality of recovery, abdominal surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group SE-TAP block
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Group M-TAPA block
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Group RS block
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
Bilateral SE-TAP
Other Intervention Name(s)
Ultrasound guided bilateral subcostal exterior semilunaris transversus abdomens plane block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bilateral M-TAPA
Other Intervention Name(s)
Ultrasound guided bilateral modified thoracoabdominal nerves block through perichondrial approach (M-TAPA)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bilateral RSB
Other Intervention Name(s)
Ultrasound guided bilateral rectus sheath block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of Recovery
Description
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).
Time Frame
At postoperative 24th hours
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
Numeric rating scale pain from 0 (no pain) to 10 (worst pain).
Time Frame
At postoperative 48 hours (2.,6.,12.,18.,24.,48.hours)
Title
Opioid consumption
Description
Morphine consumption
Time Frame
At postoperative 48 hours (2.,6.,12.,18.,24.,48.hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gulay Erdogan Kayhan, Professor
Organizational Affiliation
Eskisehir Osmangazi University Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eskisehir Osmangazi University Faculty of Medicine
City
Eskisehir
ZIP/Postal Code
26040
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27638294
Citation
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.
Results Reference
result

Learn more about this trial

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

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