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Postoperative Effects of TAP Block Versus QLB Type 2 Block

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ClinicalTrials.gov Identifier: NCT03126084
Recruitment Status : Completed
First Posted : April 24, 2017
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Bozyaka Training and Research Hospital

Brief Summary:
This study compares analgesic effectiveness of transversus abdominis plane block and quadratus lumborum block type 2 in open hernia repair surgery. All of the patients will receive routine intravenous analgesic regimen. In addition to that one-third of the patients will receive transversus abdominis plane block, one-third will receive quadratus lumborum block type 2. One-third of the patients will not receive any blocks and will constitute the control group

Condition or disease Intervention/treatment Phase
Inguinal Hernia Postoperative Pain Drug: Acetaminophen Drug: 0.25% Bupivacaine Drug: 0.5% Bupivacaine+Glucose Drug: Tramadol HCl Procedure: Inguinal Hernia Repair Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Postoperative Analgesic Effects of Transversus Abdominis Plane Block and Quadratus Lumborum Block Type 2
Actual Study Start Date : May 2, 2017
Actual Primary Completion Date : November 11, 2017
Actual Study Completion Date : November 11, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Active Comparator: TAP

Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose.

Patients will receive transversus abdominis plane block with 20 ml of 0.25% bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia.

Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.

Drug: Acetaminophen
1000 mg of intravenous acetaminophen will be administered twice a day
Other Name: Postoperative routine analgesia

Drug: 0.25% Bupivacaine
20 ml of 0.25% bupivacaine will be administered to the fascia of the transversus abdominis muscle under ultrasound guidance.
Other Name: Transversus abdominis plane block

Drug: 0.5% Bupivacaine+Glucose
15mg of 0.5% bupivacaine will be administered to subarachnoid space through 25G spinal needle
Other Name: Subarachnoid Block

Drug: Tramadol HCl
50mg of intramuscular tramadol will be administered when pain score is greater than 3 according to NRS
Other Name: Postoperative Salvage Analgesia

Procedure: Inguinal Hernia Repair
Patients will undergo open inguinal hernia repair with one of the tension free mesh techniques

Active Comparator: QLB2

Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose.

Patients will receive quadratus lumborum type 2 block with 20 ml of %0.25 bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia.

Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.

Drug: Acetaminophen
1000 mg of intravenous acetaminophen will be administered twice a day
Other Name: Postoperative routine analgesia

Drug: 0.5% Bupivacaine+Glucose
15mg of 0.5% bupivacaine will be administered to subarachnoid space through 25G spinal needle
Other Name: Subarachnoid Block

Drug: Tramadol HCl
50mg of intramuscular tramadol will be administered when pain score is greater than 3 according to NRS
Other Name: Postoperative Salvage Analgesia

Procedure: Inguinal Hernia Repair
Patients will undergo open inguinal hernia repair with one of the tension free mesh techniques

Drug: 0.25% Bupivacaine
10 ml 0.25% bupivacaine will be administered quadratus lumborum muscle and erector spinae muscle
Other Name: Quadratus lumborum block type 2

Active Comparator: CONT

Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose.

Patients will receive intravenous acetaminophen 1000mg twice a day for postoperative analgesia.

Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.

Drug: Acetaminophen
1000 mg of intravenous acetaminophen will be administered twice a day
Other Name: Postoperative routine analgesia

Drug: 0.5% Bupivacaine+Glucose
15mg of 0.5% bupivacaine will be administered to subarachnoid space through 25G spinal needle
Other Name: Subarachnoid Block

Drug: Tramadol HCl
50mg of intramuscular tramadol will be administered when pain score is greater than 3 according to NRS
Other Name: Postoperative Salvage Analgesia

Procedure: Inguinal Hernia Repair
Patients will undergo open inguinal hernia repair with one of the tension free mesh techniques




Primary Outcome Measures :
  1. Pain Intensity [ Time Frame: 24 hours after surgery ]
    Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever

  2. Pain Intensity [ Time Frame: 2 hours after surgery ]
    Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever)

  3. Pain Intensity [ Time Frame: 6 hours after surgery ]
    Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever

  4. Pain Intensity [ Time Frame: 48 hours after surgery ]
    Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are over 18 years of age
  • Patients who are scheduled for elective unilateral open hernia repair with tension free mesh techniques
  • Patients who are in ASA's physical status score group 1 or 2

Exclusion Criteria:

  • Patients who are younger than 18 years of age
  • Patients who have severe stenotic heart diseases
  • Patients who have bleeding diathesis
  • Patients who have true allergies to local anesthetics
  • Patients who have neurologic deficits corresponding to effect site of the anesthetic techniques

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): NCT03126084


Locations
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Turkey
Izmir Bozyaka Training and Research Hospital
Izmir, Turkey, 35170
Sponsors and Collaborators
Bozyaka Training and Research Hospital
Investigators
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Principal Investigator: Zeki T TEKGUL, MD Izmir Bozyaka Training and Research Hospital

Publications:
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Responsible Party: Bozyaka Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03126084     History of Changes
Other Study ID Numbers: ANES-QLB-0609
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Pain, Postoperative
Hernia, Inguinal
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical
Bupivacaine
Tramadol
Acetaminophen
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Antipyretics
Analgesics, Opioid
Narcotics