Comparison of the Quadratus Lumborum Block With the Transversus Abdominis Plan Block
NCT ID: NCT03112915
Last Updated: 2017-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2017-04-20
2018-09-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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 %
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
TAP: transversus abdominis plan block
TAP: Transversus abdominis plane block (TAP)
patients will receive a bilateral TAP block using Bupivicaine 0.25%
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* elective Laparoscopic cholecystectomy
* 19-65 years
* Written informed consent
Exclusion Criteria
* 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
19 Years
65 Years
ALL
No
Sponsors
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Kecioren Education and Training Hospital
OTHER
Responsible Party
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Merve Kacan
Assistant doctor
Locations
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Kecioren ETH
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Related Info
Other Identifiers
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02
Identifier Type: -
Identifier Source: org_study_id