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CholecystitisNCT06198335

Efficacy Of M-TAPA and TAP Block Following Laparoscopic Cholecystectomy

A study testing Modified Perichondral Approach Thoracoabdominal Nerve block and Transversus Abdominal Plane block in people with Cholecystitis, run by Mursel Ekinci at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Cholecystitis
What is being tested?
Modified Perichondral Approach Thoracoabdominal Nerve block and Transversus Abdominal Plane block
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Jan 2024to 10 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Mürsel Ekinci

    Bursa

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison Of Modified Thoracoabdominal Nerve Block Through Perichondrial Approach and Transversus Abdominal Plane Block in Analgesia Efficacy And Recovery Quality Following Laparoscopic Cholecystectomy

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.

Read the detailed description

Cholecystectomy is the most common abdominal surgical procedure in developed countries Laparoscopic cholecystectomy is considered the gold standard surgical technique for gallstones.

Several factors play a role in pain after laparoscopic cholecystectomy. This pain is complex and generally considered to be visceral. These factors are include phrenic nerve irritation caused by CO2 insufflation, abdominal distension, port incisions, the effect of gallbladder removal and individual factors.

Regional analgesia has been widely accepted by both patients and treating physicians and has become an important part of multimodal analgesia techniques. Transversus abdominis plane (TAP) block has been shown to reduce postoperative pain like hysterectomy, cholecystectomy, cesarean section and colorectal surgery.

Ultrasound (US)-guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) is performed by applying local anesthetic only to the underside of the perichondral surface. It provides effective analgesia in the anterior and lateral thoracoabdominal area.

M-TAPA is a good alternative for analgesia of the upper dermatome levels and lateral abdominal region and may be an opioid-sparing strategy that provides better quality recovery in patients undergoing laporoscopic surgery. M-TAPA provides analgesia at the T5-T11 level in the abdomen. Sonoanatomy is easy to visualize and the spread of local anesthetic can be easily seen with US guidance. Cephalo caudal spread of local anesthetic solution produces analgesia in several dermatomes. There are studies investigating the efficacy of M-TAPA for postoperative pain management in bariatric surgery in the literature.

Global recovery score (QoR) 15 is a sensitive, reliable and easy method to measure postoperative recovery quality. This scale, which has become a promising tool for assessing the quality of the recovery period, questions various aspects of recovery in 5 different areas: pain, physical comfort, physical independence, psychological support and emotional state. It may be an important scale to evaluate the outcome of changes in healthcare for quality assurance purposes in perioperative clinical studies. For these reasons, the "Standardized Endpoints in Perioperative Medicine" initiative and the European Society of Anesthesia have recommended the use of the QoR-15 scale in clinical studies investigating patient comfort and pain levels after surgery.

The aim of this study was to compare the efficacy of US-guided M-TAPA block and TAP for postoperative analgesia management after cholecystectomy. The primary outcome is to compare global recovery scores, the secondary outcome is to compare postoperative pain scores (NRS), to evaluate postoperative rescue analgesic (opioid) use and side effects (allergic reaction, nausea, vomiting) associated with opioid use in this study.

Conditions
Cholecystitis
Being tested
Modified Perichondral Approach Thoracoabdominal Nerve block, Transversus Abdominal Plane block
Keywords
Laparoscopic Cholecystectomy, Postoperative Analgesia, Modified Perichondral Approach Thoracoabdominal Nerve Block, Transversus abdominis plane block
Medical subject headings
Cholecystitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified Perichondral Approach Thoracoabdominal Nerve blockOther

    Also called Postoperative analgesia management

    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

  • Transversus Abdominal Plane blockOther

    Also called Postoperative analgesia management

    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

Study groups in NCT06198335
Study groupRoleWhat they receive
Group M-TAPA (Modified Perichondral Approach Thoracoabdominal Nerve block group)Active comparatorPatients 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.
Receives: Other: Modified Perichondral Approach Thoracoabdominal Nerve block
Group TAP (Transversus Abdominal Plane block group)Active comparatorPatients 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.
Receives: Other: Transversus Abdominal Plane block

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)
  1. Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")

    Postoperative 24 hours period. Patients' pain scores will be questioned at 0, 2, 4, 8, 16 and 24 hours.

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

  2. The use of rescue analgesia

    The need for rescue analgesia will be recorded at the first 24 hours period postoperatively.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2024
  2. Study start20 Jan 2024
  3. Primary completion20 Feb 2024
  4. Study completion10 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06198335
Sponsor's protocol ID
Bursa City Hospital 5
Status last verified
Mar 2026
First submitted
27 Dec 2023
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared

Publications

  • 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.

    PubMed 1386505
  • 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.

    PubMed 23340814
  • 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.

    PubMed 34339018
  • 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.

    PubMed 30388604
  • 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.

    PubMed 29576111

Questions about this trial

What is this clinical trial studying?

A study testing Modified Perichondral Approach Thoracoabdominal Nerve block and Transversus Abdominal Plane block in people with Cholecystitis, run by Mursel Ekinci at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global recovery scoring system (patient satisfaction scale) (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06198335, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.

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