TAP Block vs External Oblique Plane Block for Laparoscopic Cholecystectomy Surgery

NCT06178757 | Completed

• 1 other identifier: Medipol Hospital 35
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Ultrasound (US) guidedTransversus Abdominis Plane Block (TAPB) is performed by injecting a local anesthetic into the plane between the internal oblique and transverse abdominis muscles and provides analgesia in the anterolateral walls of the abdomen after abdominal surgery. Ultrasound-guided TAPB has been commonly used for many years. US-guided External oblique intercostal block (EOIB) is a novel block performed by injection of local anesthetic between the external and internal oblique muscles at the level of 6th-8th ribs. This block provides abdominal analgesia between T6 and T10 levels. There are studies in the literature showing that it provides effective analgesia. However, there is no study comparing TAPB and EOIB yet. In this study, we aim to compare the effectiveness of US-guided TAPB and EOIB 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/meperidine), and opioid-related side effects (allergic reaction, nausea, vomiting).

Conditions

Cholecystitis; Cholecystitis, Acute; Cholecystitis, Chronic

Keywords

Laparoscopic Cholesistectomy; Postoperative pain management; External oblique intercostal block; Transversus abdominis plane 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

• The use of rescue analgesia

  Postoperative 24 hours period

Study Arms (2)

Group TAPB = Transversus abdominis plane block 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: TAPB

Group EOIB = External oblique intercostal plane block 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: EOIB

Interventions

TAPB DRUG

As soon as the surgical procedure is completed, TAPB will be applied before extubation. After aseptic conditions are ensured, 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 at the level of the anterior axillary line between the 12th rib and the iliac crest, and the external oblique abdominal muscle, internal oblique abdominal muscle, and transverse abdominis muscle will be visualized. Then, using the in-plane technique, the needle will be advanced with the help of ultrasound until the needle tip reaches the space between the internal oblique and transversus abdominis muscles. After negative pressure aspiration, 5ml saline will be injected and the block location will be confirmed. Once the block location is confirmed, 20ml 0.25% bupivacaine (40ml total for each side) will be injected bilaterally.

Group TAPB = Transversus abdominis plane block group

EOIB DRUG

As soon as the surgical procedure is completed, EOIB will be applied before extubation. After aseptic conditions are ensured, the high-frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath in the supine position, and an 80 mm block needle (Braun 360°) will be used. The US probe will be placed on the 6th rib in the mid-axillary line, at the line between the anterior superior iliac spine and the umbilicus. Using the In-Plane technique, 5 ml of saline will be injected between, the external oblique muscle and the rib, and the block location will be confirmed. After confirming the block location, 20 ml 0.25% bupivacaine will be applied to the plane between 6.,7., and 8. ribs and the muscles. The same procedure will be applied to the other side (a total of 40 ml 0.25% bupivacaine).

Group EOIB = External oblique intercostal 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
• Scheduled for laparoscopic cholecystectomy surgery under general anesthesia

You may not qualify if:

• Bleeding diathesis
• anticoagulant treatment
• local anesthetics and opioid allergy
• Infection at the site of the 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 (3)

• 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; Bronchiolitis Obliterans Syndrome

Interventions

1,3-bis(4-amidinophenoxy)-2-(4-amidinophenoxymethyl)ethylpropane

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune 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 cholecystectomy surgery will be included in the study. Patients will be randomly divided into two groups (Group TAPB = TAP group, Group EOIB = EOB group) including 30 patients each, before entering the operating room.

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 21, 2023
• Study Start: December 20, 2023
• Primary Completion: July 22, 2024
• Study Completion: July 25, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)