Oblique Subcostal Tap Block Efficacy in Laparoscopic Cholecystectomy

NCT02707250 | Unknown Phase 2 DMC

• 1 other identifier: IuliuHatieganuU
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Keywords

pethidine; laparoscopic cholecystectomy; bupivacaine

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Intraoperative fentanyl consumption

  0-4 hours

• Time to first opioid administration in Post Anesthetic Care Unit

  0-4 hours postoperative

• Cumulative opioid consumption

  Recorded in the first 24 hours perioperative period

• Side effects

  Recorded in the first 24 hours postoperative

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Oblique subcostal tap block with normal sterile saline ,20 ml, bilateral, single shot,24h

Drug: Placebo

Bupivacaine

ACTIVE COMPARATOR

Oblique subcostal tap block with bupivacaine 0,25% ,20 ml, bilateral, single shot,24h

Drug: Bupivacaine

Pethidine

ACTIVE COMPARATOR

Oblique subcostal tap block with pethidine 1% ,10 ml,bilateral,single shot,24h

Drug: Pethidine

Pethidine Local Infiltration (L.I.)

ACTIVE COMPARATOR

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)

Interventions

Placebo DRUG

Tap Block performed with normal sterile saline 20 ml on the right side and 20 ml on the left side

Also known as: Tap Block Placebo

Placebo

Bupivacaine DRUG

Tap Block performed with Bupivacaine 0,25% 20 ml on the right side and 20 ml on the left side.

Also known as: Tap Block Bupivacaine

Bupivacaine

Pethidine DRUG

Tap Block performed with pethidine 1% 10 ml on the right side and 10 ml on the left side

Also known as: Tap Block Pethidine

Pethidine

Pethidine Local Infiltration (L.I) DRUG

Local infiltration of port sites (trocar insertion sites) with pethidine 1% 5ml each port (trocar site) ,4 ports total 20 ml pethidine 1%

Also known as: Pethidine Local Infiltration

Pethidine Local Infiltration (L.I.)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead

Study Sites (1)

Regional Institute of Gastroenterology and Hepatology "Prof.dr.Octavian Fodor"

Cluj-Napoca, Cluj, 400162, Romania

RECRUITING

Related Publications (1)

• 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.

  PMID: 36318686 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Bupivacaine; Meperidine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Isonipecotic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Daniela Ionescu, MD

  University of Medicine and Pharmacy "Iuliu Hatieganu" Cluj-Napoca,Romania

  STUDY DIRECTOR

Central Study Contacts

Caius M Breazu, MD

CONTACT

+40743010012; csbreazu@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Breazu Caius Mihai MD

Study Record Dates

• First Submitted: February 19, 2016
• First Posted: March 14, 2016
• Study Start: March 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 14, 2016

Record last verified: 2016-03

Locations

RO (1)