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Clinical Trials/NCT06178757
NCT06178757
Completed
N/A

Comparison of Ultrasound-Guided Transversus Abdominis Plane Block (TAP) and External Oblique Plan Block (EOIB) for Postoperative Recovery and Pain Scores After Laparoscopic Cholecystectomy Surgery

Medipol University1 site in 1 country60 target enrollmentDecember 20, 2023

Overview

Phase
N/A
Intervention
TAPB
Conditions
Cholecystitis
Sponsor
Medipol University
Enrollment
60
Locations
1
Primary Endpoint
Global recovery scoring system (patient satisfaction scale)
Status
Completed
Last Updated
last year

Overview

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).

Detailed Description

Cholecystectomy is the most common abdominal surgery performed in developed countries and is usually performed laparoscopically. The etiology of pain after laparoscopic cholecystectomy is multifactorial and is generally considered visceral pain. Diaphragmatic nerve irritation due to CO2 insufflation into the peritoneal cavity, abdominal distension, tissue damage, damage due to dissection of the gallbladder, sociocultural situation, and individual factors play a role in the occurrence of this pain.. Postoperative pain is an acute pain that is accompanied by inflammation caused by surgical stress and decreases over time with tissue healing. Pain in the postoperative period in patients undergoing laparoscopic cholecystectomy surgery is a serious problem that reduces patient comfort and delays the patient's return to work after surgery (4). Successful postoperative analgesia management prevents many of the complications such as respiratory problems and delayed mobilization (5). Transverse Abdominis Plane Block (TAPB), performed under ultrasound (US) guidance, is a block that 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 surgery. Ultrasound-guided TAPB is commonly used. TAPB provides analgesia in the abdominal region in T6-L1 dermatomes. Sonoanatomy is easy to visualize on US and the spread of local anesthetic can be seen. Analgesia occurs in several dermatomes with the cephalo-caudal spread of the local anesthetic solution. Studies are proving that TAP block is effective in some abdominal surgeries such as hysterectomy, cesarean section, cholecystectomy, inguinal hernia and prostatectomy. Sensory block areas formed by TAPB are highly variable and may result in insufficient blocks. External oblique block (EOIB) performed under US guidance is a block performed by injection of local anesthetic between the external and internal oblique muscles. This block provides abdominal analgesia covering the T6-T10 dermatomes. There are studies in the literature proving that it provides effective analgesia (12-14). However, no study comparing TAPB and EOIP has been published 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).

Registry
clinicaltrials.gov
Start Date
December 20, 2023
End Date
July 25, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Medipol University
Responsible Party
Principal Investigator
Principal Investigator

Bahadir Ciftci

Principal Investigator

Medipol University

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologists (ASA) classification I-II
  • Scheduled for laparoscopic cholecystectomy surgery under general anesthesia

Exclusion Criteria

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

Arms & Interventions

Group TAPB = Transversus abdominis plane block group

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

Intervention: TAPB

Group EOIB = External oblique intercostal plane block group

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

Intervention: EOIB

Outcomes

Primary Outcomes

Global recovery scoring system (patient satisfaction scale)

Time Frame: Change from baseline score at postoperative 24 hour

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

Secondary Outcomes

  • 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 Sites (1)

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