Analgesic Effect of TAP Block After Laparoscopic Cholecystectomy

NCT03391531 | Completed

• 1 other identifier: TAPLAPCHOL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

TAP block is a locoregional analgesic technique that consists of infiltrating a local anesthetic solution between the muscle layers of the abdominal wall. This block produces prolonged parietal analgesia. The aim of the study is to evaluate whether infiltration of the abdominal wall using TAP block reduces postoperative pain and postoperative analgesic consumption, and improves patient comfort after laparoscopic cholecystectomy. This effect will be clinically relevant only if parietal pain predominates postoperatively.

Conditions

Laparoscopic Cholecystectomy; Postoperative Analgesia

Keywords

surgery: laparoscopic cholecystectomy; analgesia: postoperative; locoregional analgesia: transversus abdominis plane block; opioid: side effects

Outcome Measures

Primary Outcomes (1)

• postoperative opioid consumption

  opioid given as an IV titration in the PACU, and opioid po on the ward

  24 hours

Secondary Outcomes (4)

• postoperative pain intensity

  24 hours

• postoperative nausea and vomiting

  24 hours

• postoperative fatigue

  24 hours

• intraoperative sevoflurane consumption

  2 hours

Study Arms (2)

levobupivacaine

ACTIVE COMPARATOR

Echo-guided bilateral subcostalTAP block will be performed using levobupivacaine \[Chirocaine®\] 0.375% Epi 1/200000.

Procedure: Bilateral subcostal TAP block

Saline

PLACEBO COMPARATOR

Echo-guided bilateral subcostal TAP block will be performed with saline Epi 1/200000 in the control group.

Procedure: Bilateral subcostal TAP block

Interventions

Bilateral subcostal TAP block PROCEDURE

Echo-guided infiltration of a local anesthetic solution in the plane located between the transversus abdominis muscle and the rectus abdominis muscle

Saline; levobupivacaine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- all patients aged 18-75 yo scheduled for laparoscopic cholecystectomy

You may not qualify if:

• Coagulation disorders
• Refusal of participation expressed by the patient
• Fibromyalgia
• Preoperative morphine treatment
• Contraindications to local anesthetics: epilepsy, severe cardiac conduction block (2nd and 3rd degree AVB ), allergy
• Contraindications to NSAIDs: renal failure, allergy, ischemic heart disease, stroke

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

CHU Liege,

Liège, 4000, Belgium

Location

Study Officials

• Jean L Joris, M.D.

  Department of Anesthesiology, CHU Liege, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Person who prepares the study solution is involved neither in any step of the care of the patient neither in the collection of the study parameters
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the department of Anesthesiology

Model Details: two groups : treatment group (TAP block with local anesthestic) compared to control group (TAP block with saline)

Study Record Dates

• First Submitted: December 29, 2017
• First Posted: January 5, 2018
• Study Start: December 27, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: July 17, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)