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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
Sponsor:
Information provided by (Responsible Party):
Merve Kacan, Kecioren Education and Training Hospital

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
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
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 : April 20, 2017
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : September 12, 2018

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 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




Primary Outcome Measures :
  1. Total cumulative morphine consumption [ Time Frame: 24 hour ]
    Total cumulative morphine dose in mg used in the first 24 hours after surgery


Secondary Outcome Measures :
  1. 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

  2. Nausea or vomiting [ Time Frame: 24 hour ]

    0 = No Nausea

    1. = Mild Nausea.
    2. = Moderate 3 = Severe Nausea or Vomiting



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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: merve kacan +90 05532529902 drmervekacan@gmail.com

Locations
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Turkey
Kecioren ETH Recruiting
Ankara, Turkey
Contact: merve kacan    +9005532529902    drmervekacan@gmail.com   
Sub-Investigator: handan gulec         
Sub-Investigator: berrin kosar         
Sub-Investigator: eyup horasanli         
Principal Investigator: merve kacan         
Sponsors and Collaborators
Kecioren Education and Training Hospital

Additional Information:
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Responsible Party: Merve Kacan, Assistant doctor, Kecioren Education and Training Hospital
ClinicalTrials.gov Identifier: NCT03112915     History of Changes
Other Study ID Numbers: 02
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Merve Kacan, Kecioren Education and Training Hospital:
postoperative pain
Laparoscopic cholecystectomy
Quadratus lumborum block
transversus abdominis plan block

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents