Oblique Subcostal Tap Block Efficacy in Laparoscopic Cholecystectomy

Pain Clinical Trial

Official title:

Oblique Subcostal Transverses Abdominal Plane Block in Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02707250
• Other study ID #: IuliuHatieganuU
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: February 19, 2016
• Last updated: March 8, 2016
• Start date: March 2015
• Est. completion date: June 2016

Study information

• Verified date: March 2016
• Source: Iuliu Hatieganu University of Medicine and Pharmacy
• Contact: Caius M Breazu, MD
• Phone: +40743010012
• Email: csbreazu[@]yahoo.com
• Is FDA regulated: No
• Health authority: Romania: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Placebo
Tap Block performed with normal sterile saline 20 ml on the right side and 20 ml on the left side
• Bupivacaine
Tap Block performed with Bupivacaine 0,25% 20 ml on the right side and 20 ml on the left side.
• Pethidine
Tap Block performed with pethidine 1% 10 ml on the right side and 10 ml on the left side
• 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%

Locations

Country	Name	City	State
Romania	Regional Institute of Gastroenterology and Hepatology "Prof.dr.Octavian Fodor"	Cluj-Napoca	Cluj

Sponsors (1)

Lead Sponsor	Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Intraoperative fentanyl consumption	Recording total amount of intraoperative fentanyl consumption	0-4 hours	No
Secondary	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	No
Secondary	Cumulative opioid consumption	Recording total amount of opioids used in postoperative period	Recorded in the first 24 hours perioperative period	No
Secondary	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	No