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

Postoperative Pain Clinical Trial

Official title:

Comparison of Quadratus Lumborum Block and Transversus Abdominis Plane Block for Postoperative Pain Control After Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03112915
• Other study ID #: 02
• Status: Recruiting
• Phase: N/A
• First received: February 27, 2017
• Last updated: September 24, 2017
• Start date: April 20, 2017
• Est. completion date: September 12, 2018

Study information

• Verified date: September 2017
• Source: Kecioren Education and Training Hospital
• Contact: merve kacan
• Phone: +90 05532529902
• Email: drmervekacan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 12, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• quadratus lumborum block
QLB: Quadratus lumborum block : 20 mL of 0.25% bupivacaine will be administered between the quadratus lumborum and the psoas major muscle bilaterally in the lateral decubitus position
• Transversus abdominis plan block
TAP: transversus abdominis plan block: 20 mL of 0.25% bupivacaine will be administered between the internal oblique muscle and the transversus abdominis muscle bilaterally in the supine position

Locations

Country	Name	City	State
Turkey	Kecioren ETH	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Kecioren Education and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total cumulative morphine consumption	Total cumulative morphine dose in mg used in the first 24 hours after surgery	24 hour
Secondary	Severity of postoperative pain via visual analogue pain scale (VAS)	VAS range from 0 for no pain to 10 for worst pain imaginable	24 hour
Secondary	Nausea or vomiting	0 = No Nausea; = Mild Nausea.; = Moderate 3 = Severe Nausea or Vomiting	24 hour

External Links

•   Link
•   Link