Oblique Subcostal Tap Block Efficacy in Laparoscopic Cholecystectomy

Oblique Subcostal Transverses Abdominal Plane Block in Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy although a minimally invasive procedure, may be accompanied by considerable pain after surgery. More recently transversus abdominis plane (TAP) block was extensively studied as a potential analgesic maneuver after laparoscopic cholecystectomy. The subcostal approach (OSTAP block) is a variation on the TAP block that produces reliable supraumbilical analgesia.

Study Overview

• Status: Unknown
• Conditions: Pain
• Intervention / Treatment: Drug: Placebo; Drug: Bupivacaine; Drug: Pethidine; Drug: Pethidine Local Infiltration (L.I)

Detailed Description

Laparoscopic cholecystectomy is a minimally invasive widespread surgical procedure, with postoperative lower pain scores and quick recovery of the patient. However some of patients may complain of considerable pain after surgery . There are several approaches to postoperative pain management after laparoscopic cholecystectomy such as patient-controlled analgesia with opioids (IV-PCA), neuraxial blocks, intraperitoneal injection of local anesthetics, wound infiltration, each being more or less effective, with specific side effects.

The transversus abdominis plane block (TAP-Block) is a regional analgesia technique that comes as an alternative to "classical" procedures of postoperative analgesia. Described by Rafi and McDonnell et al. this technique has undergone some changes over times, which increased its efficiency. Thus, Hebbard et al. described ultrasound subcostal oblique approach (OSTAP) of the block allowing analgesia in both the upper and lower abdomen, with a lower rate of complications due to the direct ultrasound visualization. Different studies confirmed the analgesic efficacy of this technique and the postoperative opioid sparing effect after laparoscopic cholecystectomy .

Traditionally, the transversus abdominis plane block is achieved with classical amino-amides local anesthetics, bupivacaine, levobupivacaine and ropivacaine being the most commonly used .

Based on the local anesthetic properties of pethidine, a synthetic opioid, our study aimed to evaluate prospectively the analgesic efficacy of pethidine in achieving transversus abdominis plane block by ultrasound oblique subcostal approach in patients scheduled for elective laparoscopic cholecystectomy.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Caius M Breazu, MD; Phone Number: +40743010012; Email: csbreazu@yahoo.com

Study Locations

• Romania
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400162
      • Recruiting
      • Regional Institute of Gastroenterology and Hepatology "Prof.dr.Octavian Fodor"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• American Society of Anaesthesiologists (ASA) I-II
• Age over 18years old
• patients scheduled elective laparoscopic cholecystectomy

Exclusion Criteria:

• Open cholecystectomy - excluded due to increased levels of pain in open procedures
• Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
• Coagulopathy or anticoagulation - increased risk of bleeding from nerve block injection
• Allergy or contraindication to any of the study medications or anesthetic agents
• Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
• Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder)
• Pregnancy
• Prisoners
• Patient or surgeon refusal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Oblique subcostal tap block with normal sterile saline ,20 ml, bilateral, single shot,24h	Drug: Placebo; Tap Block performed with normal sterile saline 20 ml on the right side and 20 ml on the left side; Other Names: Tap Block Placebo
Active Comparator: Bupivacaine; Oblique subcostal tap block with bupivacaine 0,25% ,20 ml, bilateral, single shot,24h	Drug: Bupivacaine; Tap Block performed with Bupivacaine 0,25% 20 ml on the right side and 20 ml on the left side.; Other Names: Tap Block Bupivacaine
Active Comparator: Pethidine; Oblique subcostal tap block with pethidine 1% ,10 ml,bilateral,single shot,24h	Drug: Pethidine; Tap Block performed with pethidine 1% 10 ml on the right side and 10 ml on the left side; Other Names: Tap Block Pethidine
Active Comparator: Pethidine Local Infiltration (L.I.); Local infiltration of pethidine 1% at trocar insertion sites, 5ml /site, 24h compared with Tap Block with pethidine 1%	Drug: Pethidine Local Infiltration (L.I); Local infiltration of port sites (trocar insertion sites) with pethidine 1% 5ml each port (trocar site) ,4 ports total 20 ml pethidine 1%; Other Names: Pethidine Local Infiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores	This outcome is measured with a visual analogue scale (VAS, from 0 to 10) at 2 hours postoperative, while the patient is in his bed. This outcome is recorded in and compared between all four groups.	Recorded 2 hours postoperative
Pain Scores	This outcome is measured with a visual analogue scale (VAS, from 0 to 10) at 6 hours postoperative, while the patient is in his bed. This outcome is recorded in and compared between all four groups.	Recorded 6 hours postoperative
Pain Scores	This outcome is measured with a visual analogue scale (VAS, from 0 to 10) at 12 hours postoperative, while the patient is in his bed. This outcome is recorded in and compared between all four groups.	Recorded 12 hours postoperative
Pain Scores	This outcome is measured with a visual analogue scale (VAS, from 0 to 10) at 24 hours postoperative, while the patient is in his bed. This outcome is recorded in and compared between all four groups.	Recorded 24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative fentanyl consumption	Recording total amount of intraoperative fentanyl consumption	0-4 hours
Time to first opioid administration in Post Anesthetic Care Unit	Recording time to first opioid administration in post aesthetic care unit	0-4 hours postoperative
Cumulative opioid consumption	Recording total amount of opioids used in postoperative period	Recorded in the first 24 hours perioperative period
Side effects	nausea, vomiting, pruritus and sedation on a 4 point scale as none, mild, moderate and severe	Recorded in the first 24 hours postoperative

Collaborators and Investigators

• Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
• Investigators: Study Director: Daniela Ionescu, MD, University of Medicine and Pharmacy "Iuliu Hatieganu" Cluj-Napoca,Romania

Publications and helpful links

General Publications

• Breazu C, Margarit S, Bartos A, Ionescu D. Postoperative Analgesia after Laparoscopic Cholecystectomy - Prospective, Randomized, Double Blind, Control Trial. Chirurgia (Bucur). 2022 Oct;117(5):563-571. doi: 10.21614/chirurgia.2769.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: February 19, 2016
• First Submitted That Met QC Criteria: March 8, 2016
• First Posted (Estimate): March 14, 2016

Study Record Updates

• Last Update Posted (Estimate): March 14, 2016
• Last Update Submitted That Met QC Criteria: March 8, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: bupivacaine; laparoscopic cholecystectomy; pethidine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Bupivacaine; Meperidine
• Other Study ID Numbers: IuliuHatieganuU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided