M-Tapa Block vs External Oblique Intercostal Block for Laparoscopic Cholesistectomy

NCT05502159 | Completed

• 1 other identifier: Medipol Hospital 30
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Ultrasound (US)-guided Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block is a novel block that provides effective analgesia in the anterior and lateral abdominal walls after laparoscopic surgery, and local anesthetic is applied only to the lower side of the perichondral surface. M-TAPA block is a good alternative for analgesia of the upper dermatome levels and the abdominal lateral wall and may be an opioid-sparing strategy with good quality recovery in patients undergoing laparoscopic surgery. US-guided External oblique intercostal block (EOB) is a block performed by injection of local anesthetic between the external and internal oblique muscles. This block provides abdominal analgesia between T6-T10 levels. There are studies in the literature showing that it provides effective analgesia. However, there is no study comparing M-TAPA and EOB yet. In this study, our aim is to compare the effectiveness of US-guided M-TAPA block and EOB for postoperative analgesia management after laparoscopic cholecystectomy surgery. Our primary aim is to compare patient recovery scores (QoR15 Turkish version), our secondary aim is to compare postoperative pain scores (24-hour NRS), postoperative rescue analgesic use (opioid), and opioid-related side effects (allergic reaction, nausea, vomiting).

Conditions

Cholecystitis; Cholecystitis, Acute

Keywords

Laparoscopic Cholesistectomy; Postoperative pain management; M-TAPA block; External oblique intercostal block

Outcome Measures

Primary Outcomes (1)

• Global recovery scoring system (patient satisfaction scale)

  We will use the Turkish version of Quality of Recovery / QoR-15 questionairre

  Change from baseline score at postoperative 24 hour

Secondary Outcomes (2)

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

  Postoperative 24 hours period (0, 2, 4, 8, 16 ve 24 h)

• The use of rescue analgesia

  Postoperative 24 hours period

Study Arms (2)

Group M-TAPA = M-TAPA group

ACTIVE COMPARATOR

Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. Postoperative patient evaluation will be performed by a pain nurse blinded to the procedure. 0,5 mg/kg meperidin will be performed for rescue analgesia.

Drug: M-TAPA

Group EOB = EOB group

ACTIVE COMPARATOR

Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. Postoperative patient evaluation will be performed by a pain nurse blinded to the procedure. 0,5 mg/kg meperidin will be performed for rescue analgesia.

Drug: EOB

Interventions

M-TAPA DRUG

Under aseptic conditions, a high-frequency linear probe will be placed on the costochondral angle in the sagittal plane. Then the probe will be slightly angled deeply to visualize the lower view of the perichondrium. We will perform M-TAPA with total of 40 ml (20 ml for each side) of %0,25 bupivacaine.

Group M-TAPA = M-TAPA group

EOB DRUG

In the supine position, a 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 on the midaxillary line between the spina iliaca anterior superior and the umbilicus. Using the In-Plane technique, 5 ml of saline will be injected under the external oblique muscle of the block needle and the block location will be confirmed. After the block location is confirmed, 20 ml of 0.25% bupivacaine will be administered. The same procedure will be applied to the other side (40 ml of 0.25% bupivacaine in total).

Group EOB = EOB 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
• Scheduled for laparoscopic inguinal hernia repair surgery under general anesthesia

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

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related Publications (6)

• 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

• Altiparmak B, Toker MK, Uysal AI, Turan M, Demirbilek SG. Reply to Tulgar et al.: Perichondral approach for blockage of thoracoabdominal nerves: Anatomical basis and clinical experience in three cases. J Clin Anesth. 2019 May;54:150-151. doi: 10.1016/j.jclinane.2018.12.005. Epub 2018 Dec 12. No abstract available.

  PMID: 30553219 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

• Elsharkawy H, Kolli S, Soliman LM, Seif J, Drake RL, Mariano ER, El-Boghdadly K. The External Oblique Intercostal Block: Anatomic Evaluation and Case Series. Pain Med. 2021 Nov 26;22(11):2436-2442. doi: 10.1093/pm/pnab296.

  PMID: 34626112 BACKGROUND

• Hamilton DL, Manickam BP, Wilson MAJ, Abdel Meguid E. External oblique fascial plane block. Reg Anesth Pain Med. 2019 Jan 11:rapm-2018-100256. doi: 10.1136/rapm-2018-100256. Online ahead of print. No abstract available.

  PMID: 30635518 BACKGROUND

• Tulgar S, Ahiskalioglu A, Selvi O, Thomas DT, Ozer Z. Similarities between external oblique fascial plane block and blockage of thoracoabdominal nerves through perichondral approach (TAPA). J Clin Anesth. 2019 Nov;57:91-92. doi: 10.1016/j.jclinane.2019.03.027. Epub 2019 Mar 29. No abstract available.

  PMID: 30933854 BACKGROUND

MeSH Terms

Conditions

Cholecystitis; Cholecystitis, Acute

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: Outcomes Assessor and participant were blinded to the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Sixty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for laparoscopic cholesistectomy surgery will be included in the study. Patients will be randomly divided into two groups (Group M = M-TAPA group, Group EOB = EOB group) including 30 patients each, before entering the operating room.

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 16, 2022
• Study Start: August 23, 2022
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)