Efficacy Of M-TAPA and TAP Block Following Laparoscopic Cholecystectomy

NCT06198335 | Completed

• 1 other identifier: Bursa City Hospital 5
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Cholecystectomy is the most common abdominal surgical procedure in developed countries Laparoscopic cholecystectomy is considered the gold standard surgical technique for gallstones. The analgesic effectiveness of TAP block has been demonstrated after laparoscopic cholecystectomy operations. m-TAPA block has been described as an alternative analgesic technique in abdominal surgeries. The aim of this study is to compare these two analgesic methods in terms of effectiveness for postoperative analgesia management after laparoscopic cholecystectomy operations.

Conditions

Cholecystitis

Keywords

Laparoscopic Cholecystectomy; Postoperative Analgesia; Modified Perichondral Approach Thoracoabdominal Nerve Block; Transversus abdominis plane block

Outcome Measures

Primary Outcomes (1)

• Global recovery scoring system (patient satisfaction scale)

  The investigators will use the Turkish version of Quality of Recovery / QoR-15 questionairre PART A How have you been feeling in the last 24 hours? (0 to 10, where: 0 = none of the time \[poor\] and 10 = all of the time \[excellent\]) 1. Able to breathe easily 2. Been able to enjoy food 3. Feeling rested 4. Have had a good sleep 5. Able to look after personal toilet and hygiene unaided 6. Able to communicate with 7. Getting support from hospital doctors and nurses 8. Able to return to work or usual home activities 9. Feeling comfortable and in control 10. Having a feeling of general well-being PART B Have you had any of the following in the last 24 hours? (10 to 0, where: 10 = none of the time \[excellent\] and 0 = all of the time \[poor\]) 11. Moderate pain 12. Severe pain 13. Nausea or vomiting 14. Feeling worried or anxious 15. Feeling sad or depressed

  The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 24th hour.

Secondary Outcomes (2)

• Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")

  Patients will be evaluated at the first 24 hours period postoperatively.

• The use of rescue analgesia

  Meperidine consumption will be recorded at the first 24 hours period postoperatively.(total mg dose)

Study Arms (2)

Group M-TAPA (Modified Perichondral Approach Thoracoabdominal Nerve block group)

ACTIVE COMPARATOR

Patients will be performed to block at the end of the surgery. Patients will be administered paracetamol 1 gr (PERFALGAN® ) IV every 8 hours in the postoperative period.. If the patient's NRS score is ≥ 4 0,5 mg/kg IV meperidine (Aldolan ampul 100 mg/2 ml) will be administered.

Other: Modified Perichondral Approach Thoracoabdominal Nerve block

Group TAP (Transversus Abdominal Plane block group)

ACTIVE COMPARATOR

Patients will be performed to block at the end of the surgery. Patients will be administered paracetamol 1 gr (PERFALGAN® ) IV every 8 hours in the postoperative period.. If the patient's NRS score is ≥ 4 0,5 mg/kg IV meperidine (Aldolan ampul 100 mg/2 ml) will be administered.

Other: Transversus Abdominal Plane block

Interventions

Modified Perichondral Approach Thoracoabdominal Nerve block OTHER

M-TAPA block will be performed to Group M-TAPA at the end of the surgery, using US (Vivid Q) while the patient is in the supine position After providing aseptic conditions, the high frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath, and an 80 mm block needle (Braun 360°) will be used. The US probe will be placed in the sagittal plane where the midclavicular line intersects with the costal cartilage corresponding to the costochondral angle. Using the In Plane technique, the probe is gently pushed to visualize the lower part of the costochondral angle at the central level, advancing the block needle in the caudal-cranio direction, 5 ml of saline will be injected into the layer between the transverse abdominal muscle and the lower plane of the costal cartilage, and the block location will be confirmed. After the block location is confirmed, a total of 20 ml + 20 ml of 0.25% bupivacaine (total 40 ml for both sides) will be injected bilaterally

Also known as: Postoperative analgesia management

Group M-TAPA (Modified Perichondral Approach Thoracoabdominal Nerve block group)

Transversus Abdominal Plane block OTHER

TAP block will be performed to Group TAP at the end of the surgery, using US (Vivid Q) while the patient is in the supine position. After providing aseptic conditions, the high frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath, and an 80 mm block needle (Braun 360°) will be used. USG will be placed transversely on the mid-axillary line between the iliac crest and subcostal planes. Using the In Plane technique, the block needle will be advanced into the fascial plane between the internal oblique and transversus abdominis muscles and the location will be confirmed by administering 5 ml of saline. The block needle will be advanced into the fascial plane between the internal oblique and transversus abdominis muscles and the location will be confirmed by administering 5 ml of saline.and than 20 ml of 0.25% bupivacaine (total 40 ml for both sides) will be injected bilaterally

Also known as: Postoperative analgesia management

Group TAP (Transversus Abdominal Plane block group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) classification I-II
• Elective laparoscopic cholecystectomy

You may not qualify if:

• Bleeding diathesis
• Anticoagulant treatment
• Local anesthetics and opioid allergy
• Infection at the site of block
• Patients who do not accept the procedure

Sponsors & Collaborators

• Mursel Ekinci: lead
• Mustafa Dikici: collaborator
• Ahmet Kaciroglu: collaborator

Study Sites (1)

Mürsel Ekinci

Bursa, Turkey (Türkiye)

Location

Related Publications (5)

• Soper NJ, Stockmann PT, Dunnegan DL, Ashley SW. Laparoscopic cholecystectomy. The new 'gold standard'? Arch Surg. 1992 Aug;127(8):917-21; discussion 921-3. doi: 10.1001/archsurg.1992.01420080051008.

  PMID: 1386505 BACKGROUND

• Donatsky AM, Bjerrum F, Gogenur I. Surgical techniques to minimize shoulder pain after laparoscopic cholecystectomy. A systematic review. Surg Endosc. 2013 Jul;27(7):2275-82. doi: 10.1007/s00464-012-2759-5. Epub 2013 Jan 24.

  PMID: 23340814 BACKGROUND

• de Oliveira EJSG, De Lima RC, Sakata RK, Freire TT, de Almeida Lima EL, de Oliveira CMB, Moura ECR, da Cunha Leal P. Modified Thoracoabdominal Nerve Block Through the Perichondral Approach (M-TAPA) in Laparoscopic Sleeve Gastroplasty: A Case Series. Obes Surg. 2022 Jan;32(1):197-201. doi: 10.1007/s11695-021-05612-6. Epub 2021 Aug 2. No abstract available.

  PMID: 34339018 BACKGROUND

• Tulgar S, Senturk O, Selvi O, Balaban O, Ahiskalioglu A, Thomas DT, Ozer Z. Perichondral approach for blockage of thoracoabdominal nerves: Anatomical basis and clinical experience in three cases. J Clin Anesth. 2019 May;54:8-10. doi: 10.1016/j.jclinane.2018.10.015. Epub 2018 Oct 31. No abstract available.

  PMID: 30388604 BACKGROUND

• Myles PS, Boney O, Botti M, Cyna AM, Gan TJ, Jensen MP, Kehlet H, Kurz A, De Oliveira GS Jr, Peyton P, Sessler DI, Tramer MR, Wu CL; StEP-COMPAC Group; Myles P, Grocott M, Biccard B, Blazeby J, Boney O, Chan M, Diouf E, Fleisher L, Kalkman C, Kurz A, Moonesinghe R, Wijeysundera D. Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: patient comfort. Br J Anaesth. 2018 Apr;120(4):705-711. doi: 10.1016/j.bja.2017.12.037. Epub 2018 Feb 2.

  PMID: 29576111 BACKGROUND

MeSH Terms

Conditions

Cholecystitis

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient and the outcomes assessor who performs postoperative pain evaluation will not know the group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc prof

Model Details: There are two models for this study. Modified Perichondral Approach Thoracoabdominal Nerve block (M-TAPA block) group, and Transversus Abdominal Plane Block (TAP block) group

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 10, 2024
• Study Start: January 20, 2024
• Primary Completion: February 20, 2024
• Study Completion: August 10, 2025
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)