Postoperative Effects of TAP Block Versus QLB Type 2 Block

Comparison of Postoperative Analgesic Effects of Transversus Abdominis Plane Block and Quadratus Lumborum Block Type 2

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Inguinal Hernia
• Intervention / Treatment: Drug: Acetaminophen; Drug: 0.25% Bupivacaine; Drug: 0.5% Bupivacaine+Glucose; Drug: Tramadol HCl; Procedure: Inguinal Hernia Repair; Drug: 0.25% Bupivacaine

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey, 35170
    • Izmir Bozyaka Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: Subarachnoid Block; Drug: Tramadol HCl; 50mg of intramuscular tramadol will be administered when pain score is greater than 3 according to NRS; Other Names: 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 Names: Quadratus lumborum block type 2
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 Names: 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 Names: 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 Names: Subarachnoid Block; Drug: Tramadol HCl; 50mg of intramuscular tramadol will be administered when pain score is greater than 3 according to NRS; Other Names: 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 Names: 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 Names: Postoperative routine analgesia; Drug: 0.5% Bupivacaine+Glucose; 15mg of 0.5% bupivacaine will be administered to subarachnoid space through 25G spinal needle; Other Names: Subarachnoid Block; Drug: Tramadol HCl; 50mg of intramuscular tramadol will be administered when pain score is greater than 3 according to NRS; Other Names: Postoperative Salvage Analgesia; Procedure: Inguinal Hernia Repair; Patients will undergo open inguinal hernia repair with one of the tension free mesh techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever	24 hours after surgery
Pain Intensity	Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever)	2 hours after surgery
Pain Intensity	Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever	6 hours after surgery
Pain Intensity	Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever	48 hours after surgery

Collaborators and Investigators

• Sponsor: Bozyaka Training and Research Hospital

Publications and helpful links

General Publications

• McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.
• Finnerty O, Carney J, McDonnell JG. Trunk blocks for abdominal surgery. Anaesthesia. 2010 Apr;65 Suppl 1:76-83. doi: 10.1111/j.1365-2044.2009.06203.x.
• Baerentzen F, Maschmann C, Jensen K, Belhage B, Hensler M, Borglum J. Ultrasound-guided nerve block for inguinal hernia repair: a randomized, controlled, double-blind study. Reg Anesth Pain Med. 2012 Sep-Oct;37(5):502-7. doi: 10.1097/AAP.0b013e31825a3c8a.
• Okur O, Karaduman D, Tekgul ZT, Koroglu N, Yildirim M. Posterior quadratus lumborum versus transversus abdominis plane block for inguinal hernia repair: a prospective randomized controlled study. Braz J Anesthesiol. 2021 Sep-Oct;71(5):505-510. doi: 10.1016/j.bjane.2020.11.004. Epub 2021 Feb 10.

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2017
• Primary Completion (Actual): November 11, 2017
• Study Completion (Actual): November 11, 2017

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 11, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Acetaminophen; Bupivacaine; Tramadol
• Other Study ID Numbers: ANES-QLB-0609

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No