Comparison of the Quadratus Lumborum Block With the Transversus Abdominis Plan Block

Not Applicable

• Conditions: Postoperative Pain

• Registration Number: NCT03112915
• Lead Sponsor: Kecioren Education and Training Hospital

Brief Summary

In this study, investigators aimed to compare the Quadratus Lumborum Block and the Transversus Abdominis Plan Block for postoperative pain control after laparoscopic cholecystectomy

Detailed Description

After ethical committee approval, informed written consent will be obtained from all patients.

A Sample size of 60 patients (30 per group) was calculated based on 15% reduction in morphine consumption with 0.05% significance and a power of 0.8.

Consenting patients scheduled to have elective laparoscopic cholecystectomy under general anesthesia will be randomized to receive bilateral QLB or TAP before the surgery. The dose of local anesthetic in both groups will be 20 ml 0.25% Bupivacaine. Allocation to either group will be done using permuted block randomization method.

Patients will be taken to the block room 1 hour before surgery. ECG, NIBP and SpO2 monitor will be done. The IV access route will be provided. The patient will be given 0.03 mg / kg IV midazolam for routine premedication. Block will be applied by a blind anesthetist to the other data of the study. Under ultrasound guidance a 22 Gauge Sonoplex needle will be used for both techniques. The calculated dose of local anesthetic will be injected bilaterally with intermittent aspiration. The spread of injectate will be seed on ultrasound.

The procedure time for both blocks will be recorded and 30 minutes after the procedure is completed, and the patient will be taken to the operation room. General anesthesia will be applied to the patient in the operation procedure in the standard procedure. Intraoperative heart rate and / or mean arterial pressure is increased to 20% of the basal value and 0.5 mcg / kg IV fentanyl will be added. 30 minutes before the end of operation, 1 mg IV paracetamol and NSAID (dexketoprofen) 50 mg IV will be administered to the patient before extubation. The patient will be infected with IV PCA in the morphine. PC 1 mg IV bolus dose will be adjusted to 10 minutes of locked-out period. In the postoperative period, 4 \* 1 gr / 24 h IV paracetamol will be given to each patient.

All patients will be assessed postoperatively by a blinded investigator: in the post-anesthesia care unit and at 0, 2, 4, 6, 12 and 24 h postoperatively.

Study Timeline

• Study First Submitted: 2017-02-27
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-13
• Study Start: 2017-04-20
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-24
• Last Update Posted: 2017-09-26
• Primary Completion: 2018-08-01
• Study Completion: 2018-09-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• ASA 1-2-3
• elective Laparoscopic cholecystectomy
• 19-65 years
• Written informed consent

Exclusion Criteria

• Patient refusal Local infection at the site of injection
• Allergy to study medications Sepsis Anatomic abnormalities Systemic anticoagulation or coagulopathy - Inability to comprehend or participate in pain scoring system
• Inability to use intravenous patient controlled analgesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total cumulative morphine consumption	24 hour	Total cumulative morphine dose in mg used in the first 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Nausea or vomiting	24 hour	0 = No Nausea; 1. = Mild Nausea.; 2. = Moderate 3 = Severe Nausea or Vomiting
Severity of postoperative pain via visual analogue pain scale (VAS)	24 hour	VAS range from 0 for no pain to 10 for worst pain imaginable

Trial Locations

Locations (1)

Kecioren ETH; 🇹🇷 Ankara, Turkey