Effectiveness Of Modified-Thoracoabdominal Nerve Block Perichondrial Approach (M-TAPA) In Laparoscopic Cholecystectomy

NCT06652581 | Recruiting

• 1 other identifier: 2176/UN14.2.2.VII.14/LT/2024
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The Goal of this clinical trial is to determine the advantages of using Peripheral Nerve Block by injecting drugs under the skin on both sides of the abdomen in the upper abdominal area in patients undergoing laparoscopic Cholecystectomy. Study participants will be divided into 2 groups, namely group P1 receiving Modified Thoracoabdominal Perichondrial Approach (M-TAPA) block anesthesia after laparoscopic cholecystectomy and group P2 only receiving intravenous opioids postoperatively. Peripheral nerve blocks on both sides of the upper abdomen are expected to be able to prolong the duration of pain relief, reduce the pain scale, and the total dose of pain medication needed postoperatively. The injection of this peripheral nerve block drug will be carried out by an anesthesiologist. Researchers will continue to anticipate the occurrence of side effects that can occur with strict monitoring and emergency care standards. This study will last up to 24 hours after surgery. The main question it aims to answer is: To prove that the amount of postoperative intravenous opioid consumption with M-TAPA block is lower than the control group.

Conditions

Laparoscopic Cholecystectomy; Peripheral Nerve Block

Keywords

Analgesia; Laparoscopy Cholecystectomy; Peripheral Nerve Block; Pain management; Ultrasound; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Proving the effectiveness of postoperative analgesia with Modified-Thoracoabdominal Nerve Block Perichondrial Approach (M-TAPA) in laparoscopic cholecystectomy patients at Prof. I.G.N.G. Ngoerah General Hospital.

  Evaluate total PCA Intravena opioid consumption (morphin in mg) delivered dose.

  24 hours

Secondary Outcomes (2)

• Numeric rating Scale

  24 hours

• QoR 40

  24 hours

Study Arms (2)

Modified Thorachoabdominal Nerve Block Perichondrial Approach(M-TAPA)

EXPERIMENTAL

USG Guided Bilateral Modified Thorachoabdominal Nerve Block Perichondrial Approach (M-TAPA) using 20 ml Bupivacaine 0,25%.

Procedure: Modified Thorachoabdominal Nerve Block Perichondrial Approach(M-TAPA

Opioid Intravena

ACTIVE COMPARATOR

This Group receive opioid intravena post surgery without M-TAPA Block

Device: Opioid Intravena

Interventions

Modified Thorachoabdominal Nerve Block Perichondrial Approach(M-TAPA PROCEDURE

USG Guided Bilateral Modified Thorachoabdominal Nerve Block Perichondrial Approach (M-TAPA) using 20 ml Bupivacaine 0,25%.

Also known as: P1

Modified Thorachoabdominal Nerve Block Perichondrial Approach(M-TAPA)

Opioid Intravena DEVICE

Opioid Intravenous post Surgery without M-TAPA Block delivered with PCA Machine

Also known as: P2

Opioid Intravena

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient 18-65 yeasr old
• IMT 17.5-30 kg/m2
• Patient with ASA I-II

You may not qualify if:

• Patient Refusal
• Local Infection
• Chronic Analgesia drug user

Sponsors & Collaborators

• Udayana University: lead

Study Sites (1)

Prof I.G.N.G Ngoerah General Hospital

Denpasar, Bali, 80113, Indonesia

RECRUITING

Related Publications (9)

• Blythe J, Herrmann E, Faust D, Falk S, Edwards-Lehr T, Stockhausen F, Hanisch E, Buia A. Acute cholecystitis - a cohort study in a real-world clinical setting (REWO study, NCT02796443). Pragmat Obs Res. 2018 Oct 25;9:69-75. doi: 10.2147/POR.S169255. eCollection 2018.

  PMID: 30498388 BACKGROUND

• Castillo-Davila LF, Torres-Anaya CJ, Vazquez-Apodaca R, Borboa-Olivares H, Espino-Y-Sosa S, Torres-Torres J. Modified thoracoabdominal nerve block via perichondral approach: an alternative for perioperative pain management in laparoscopic cholecystectomy in a middle-income country. BMC Anesthesiol. 2024 Aug 31;24(1):304. doi: 10.1186/s12871-024-02690-8.

  PMID: 39217281 BACKGROUND

• El-Boghdadly K, Pawa A, Chin KJ. Local anesthetic systemic toxicity: current perspectives. Local Reg Anesth. 2018 Aug 8;11:35-44. doi: 10.2147/LRA.S154512. eCollection 2018.

  PMID: 30122981 BACKGROUND

• Erbabacan E, Kendigelen P, Koksal GM, Tutuncu C, Ekici BB, Seker TB, Kaya G, Altindas F. Comparison of Transversus Abdominis Plane Block and IV Patient-Controlled Analgesia after Lower Abdominal Surgery. Turk J Anaesthesiol Reanim. 2015 Feb;43(1):24-8. doi: 10.5152/TJAR.2014.82788. Epub 2014 Dec 9.

  PMID: 27366460 BACKGROUND

• Fakhoury HMA, Yousef Z, Tamim H, Daher S, Attasi AA, Al Ajlan A, Hajeer AH. Combined effect of age and body mass index on postoperative mortality and morbidity in laparoscopic cholecystectomy patients. Front Surg. 2023 Nov 23;10:1243915. doi: 10.3389/fsurg.2023.1243915. eCollection 2023.

  PMID: 38074287 BACKGROUND

• Gungor H, Ciftci B, Alver S, Golboyu BE, Ozdenkaya Y, Tulgar S. Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) vs local infiltration for pain management after laparoscopic cholecystectomy surgery: a randomized study. J Anesth. 2023 Apr;37(2):254-260. doi: 10.1007/s00540-022-03158-0. Epub 2022 Dec 28.

  PMID: 36575362 BACKGROUND

• 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: 30639940 BACKGROUND

• Bilge A, Basaran B, Et T, Korkusuz M, Yarimoglu R, Toprak H, Kumru N. Ultrasound-guided bilateral modified-thoracoabdominal nerve block through a perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy: a randomized double-blind controlled trial. BMC Anesthesiol. 2022 Oct 28;22(1):329. doi: 10.1186/s12871-022-01866-4.

  PMID: 36307755 RESULT

• Erten E, Kara U, Simsek F, Oztas M, Suzer MA, Kamburoglu H, Eskin MB, Senkal S, Cosar A. Modified thoracoabdominal nerves block through perichondrial approach for laparoscopic cholecystectomy. Rev Assoc Med Bras (1992). 2024 Apr 22;70(3):e20230962. doi: 10.1590/1806-9282.20230962. eCollection 2024.

  PMID: 38655995 RESULT

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Study Officials

• WHO WHO

  World Health Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amelia Christiana, MD

CONTACT

+6282398565260; ameliachristiana@student.unud.ac.id

Ita Indriani, MD

CONTACT

+6281284847887; indriani.ita@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 22, 2024
• Study Start: September 12, 2024
• Primary Completion: November 12, 2024
• Study Completion: November 13, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)