Comparison of the Quadratus Lumborum Block With the Transversus Abdominis Plan Block
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|ClinicalTrials.gov Identifier: NCT03112915|
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : September 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Procedure: quadratus lumborum block Procedure: Transversus abdominis plan block||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-blind randomized controlled trail|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||Double-blind randomized controlled trail|
|Official Title:||Comparison of Quadratus Lumborum Block and Transversus Abdominis Plane Block for Postoperative Pain Control After Laparoscopic Cholecystectomy|
|Actual Study Start Date :||April 20, 2017|
|Estimated Primary Completion Date :||August 1, 2018|
|Estimated Study Completion Date :||September 12, 2018|
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 Name: 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 Name: TAP block
- Total cumulative morphine consumption [ Time Frame: 24 hour ]Total cumulative morphine dose in mg used in the first 24 hours after surgery
- Severity of postoperative pain via visual analogue pain scale (VAS) [ Time Frame: 24 hour ]VAS range from 0 for no pain to 10 for worst pain imaginable
- Nausea or vomiting [ Time Frame: 24 hour ]
0 = No Nausea
- = Mild Nausea.
- = Moderate 3 = Severe Nausea or Vomiting
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112915
|Contact: merve kacan||+90 email@example.com|
|Contact: merve kacan +9005532529902 firstname.lastname@example.org|
|Sub-Investigator: handan gulec|
|Sub-Investigator: berrin kosar|
|Sub-Investigator: eyup horasanli|
|Principal Investigator: merve kacan|