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

Sponsor

Kecioren Education and Training Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03112915

Collaborator

(none)

Enrollment

Location

Arms

16.8

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Procedure: quadratus lumborum block Procedure: Transversus abdominis plan block	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double-blind randomized controlled trailDouble-blind randomized controlled trail

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

Double-blind randomized controlled trail

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 20, 2017

Anticipated Primary Completion Date :

Aug 1, 2018

Anticipated Study Completion Date :

Sep 12, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: QLB: Quadratus lumborum block QLB: Quadratus lumborum block :Quadratus Lumborum block group (QL) patients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.25 %	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 Other Names: QLB
Active Comparator: TAP: transversus abdominis plan block TAP: Transversus abdominis plane block (TAP) patients will receive a bilateral TAP block using Bupivicaine 0.25%	Procedure: 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 Other Names: TAP block

Arm

Intervention/Treatment

Active Comparator: QLB: Quadratus lumborum block

QLB: Quadratus lumborum block :Quadratus Lumborum block group (QL) patients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.25 %

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

Other Names:

QLB

Active Comparator: TAP: transversus abdominis plan block

TAP: Transversus abdominis plane block (TAP) patients will receive a bilateral TAP block using Bupivicaine 0.25%

Procedure: 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

Other Names:

TAP block

Outcome Measures

Primary Outcome Measures

Total cumulative morphine consumption [24 hour]
Total cumulative morphine dose in mg used in the first 24 hours after surgery

Secondary Outcome Measures

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
Nausea or vomiting [24 hour]
0 = No Nausea = Mild Nausea. = Moderate 3 = Severe Nausea or Vomiting

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kecioren ETH	Ankara		Turkey

Sponsors and Collaborators

Kecioren Education and Training Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Merve Kacan, Assistant doctor, Kecioren Education and Training Hospital

ClinicalTrials.gov Identifier:

NCT03112915

Other Study ID Numbers:

First Posted:

Apr 13, 2017

Last Update Posted:

Sep 26, 2017

Last Verified:

Sep 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Merve Kacan, Assistant doctor, Kecioren Education and Training Hospital

postoperative pain

Laparoscopic cholecystectomy

Quadratus lumborum block

transversus abdominis plan block

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Sep 26, 2017