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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03112915
Enrollment
60
Registered
2017-04-13
Start date
2017-04-20
Completion date
2018-09-12
Last updated
2017-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

postoperative pain, Laparoscopic cholecystectomy, Quadratus lumborum block, transversus abdominis plan block

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.

Interventions

PROCEDUREquadratus 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

PROCEDURETransversus 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

Sponsors

Kecioren Education and Training Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Double-blind randomized controlled trail

Intervention model description

Double-blind randomized controlled trail

Eligibility

Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Total cumulative morphine consumption24 hourTotal cumulative morphine dose in mg used in the first 24 hours after surgery

Secondary

MeasureTime frameDescription
Severity of postoperative pain via visual analogue pain scale (VAS)24 hourVAS range from 0 for no pain to 10 for worst pain imaginable
Nausea or vomiting24 hour0 = No Nausea 1. = Mild Nausea. 2. = Moderate 3 = Severe Nausea or Vomiting

Countries

Turkey (Türkiye)

Contacts

Primary Contactmerve kacan
drmervekacan@gmail.com+90 05532529902

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026