NCT06540586

Brief Summary

Comparison of Postoperative Analgesic Effects of M-TAPA and Anterior Quadratus Lumborum Blocks in Laparoscopic Cholecystectomies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

August 2, 2024

Last Update Submit

July 9, 2025

Conditions

Keywords

postoperative painlaparoscopic cholecystectomyquadratus lumborum blockm-tapa blockabdominal wall blockspostoperative analgesia

Outcome Measures

Primary Outcomes (1)

  • Total amount of opioid requirements

    The total tramadol use of the patients in 24 hours will be recorded.

    within 24 hours after the surgery

Secondary Outcomes (1)

  • rescue analgesia

    within 24 hours after the surgery

Other Outcomes (3)

  • intraoperative remifentanil consumption

    during operation procedure]

  • Visual Analogue Scale values

    at 1st, 4th,8th 12th and 24th hours after the surgery]

  • side effects such as nausea, vomiting and shoulder pain

    within 24 hours after the surgery

Study Arms (2)

Quadratus lumborum block group

ACTIVE COMPARATOR

Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected. The same is done to the opposite side.

Procedure: anterior Quadratus lumborum block

m-tapa block

ACTIVE COMPARATOR

In the M-TAPA block group, with the patient in the supine position, a linear high-frequency linear ultrasound (USG) probe is angled to visualize the inferior surface of the costochondral junction at the level of the 10th costochondral cartilage. Under sterile conditions, using the in-plane technique with a 22G 80 mm peripheral block needle, the needle is advanced posterior to the 10th costal cartilage by taking the lower edge of the cartilage in the sagittal plane as the midline. After hydrodissection with 2-3 ml isotonic saline to confirm the site, 20 ml of 0.25% Bupivacaine is administered under USG guidance. The same procedure is performed on the contralateral side as well.

Procedure: M-TAPA BLOCK

Interventions

Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected. The same is done to the opposite side.

Quadratus lumborum block group
M-TAPA BLOCKPROCEDURE

In the M-TAPA block group, with the patient in the supine position, a linear high-frequency linear ultrasound (USG) probe is angled to visualize the inferior surface of the costochondral junction at the level of the 10th costochondral cartilage. Under sterile conditions, using the in-plane technique with a 22G 80 mm peripheral block needle, the needle is advanced posterior to the 10th costal cartilage by taking the lower edge of the cartilage in the sagittal plane as the midline. After hydrodissection with 2-3 ml isotonic saline to confirm the site, 20 ml of 0.25% Bupivacaine is administered under USG guidance. The same procedure is performed on the contralateral side as well.

m-tapa block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • scheduled for elective Laparoscopic chplecystectomy
  • Patients aged ≥18 years
  • American Society of Anesthesiologists physical status (ASA) Ⅰ-II

You may not qualify if:

  • ASA III-IV patient
  • local anesthetic allergy
  • Infection at the procedure site Body Mass Index \>35 kg/m2 Anticoagulant use with bleeding disorder Chronic analgesia and opioid use with mental and psychiatric disorders Contraindications to regional anesthesia several lung and heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa Research and Education Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (3)

  • Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. doi: 10.1097/ALN.0000000000002524. No abstract available.

    PMID: 30688787BACKGROUND
  • Aygun H, Kavrut Ozturk N, Pamukcu AS, Inal A, Kiziloglu I, Thomas DT, Tulgar S, Nart A. Comparison of ultrasound guided Erector Spinae Plane Block and quadratus lumborum block for postoperative analgesia in laparoscopic cholecystectomy patients; a prospective randomized study. J Clin Anesth. 2020 Jun;62:109696. doi: 10.1016/j.jclinane.2019.109696. Epub 2019 Dec 18.

    PMID: 31862217BACKGROUND
  • Tulgar S, Selvi O, Thomas DT, Deveci U, Ozer Z. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides effective analgesia in abdominal surgery and is a choice for opioid sparing anesthesia. J Clin Anesth. 2019 Aug;55:109. doi: 10.1016/j.jclinane.2019.01.003. Epub 2019 Jan 9. No abstract available.

    PMID: 30639940BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • serpil sehirlioglu, MD

    Gaziosmanpasa Research and Education Hospital

    PRINCIPAL INVESTIGATOR
  • turan aydemir, MD

    Gaziosmanpasa Research and Education Hospital

    STUDY DIRECTOR
  • döndü moralar, MD

    Gaziosmanpasa Research and Education Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 2, 2024

First Posted

August 6, 2024

Study Start

May 1, 2024

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations