NCT03126084

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

May 2, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2017

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

6 months

First QC Date

April 20, 2017

Last Update Submit

November 11, 2017

Conditions

Inguinal HerniaPostoperative Pain

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (3)

TAP

ACTIVE COMPARATOR

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: AcetaminophenDrug: 0.25% BupivacaineDrug: 0.5% Bupivacaine+GlucoseDrug: Tramadol HClProcedure: Inguinal Hernia Repair

QLB2

ACTIVE COMPARATOR

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: AcetaminophenDrug: 0.5% Bupivacaine+GlucoseDrug: Tramadol HClProcedure: Inguinal Hernia RepairDrug: 0.25% Bupivacaine

CONT

ACTIVE COMPARATOR

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: AcetaminophenDrug: 0.5% Bupivacaine+GlucoseDrug: Tramadol HClProcedure: Inguinal Hernia Repair

Interventions

AcetaminophenDRUG

1000 mg of intravenous acetaminophen will be administered twice a day

Also known as: Postoperative routine analgesia
CONTQLB2TAP
0.25% BupivacaineDRUG

20 ml of 0.25% bupivacaine will be administered to the fascia of the transversus abdominis muscle under ultrasound guidance.

Also known as: Transversus abdominis plane block
TAP
0.5% Bupivacaine+GlucoseDRUG

15mg of 0.5% bupivacaine will be administered to subarachnoid space through 25G spinal needle

Also known as: Subarachnoid Block
CONTQLB2TAP
Tramadol HClDRUG

50mg of intramuscular tramadol will be administered when pain score is greater than 3 according to NRS

Also known as: Postoperative Salvage Analgesia
CONTQLB2TAP
Inguinal Hernia RepairPROCEDURE

Patients will undergo open inguinal hernia repair with one of the tension free mesh techniques

CONTQLB2TAP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Bozyaka Training and Research Hospital

Izmir, 35170, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 17179269BACKGROUND

  • 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.

    PMID: 22705951BACKGROUND

  • 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.

    PMID: 20377549BACKGROUND

  • 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.

    PMID: 34537121DERIVED

MeSH Terms

Conditions

Hernia, InguinalPain, Postoperative

Interventions

AcetaminophenBupivacaineAnesthesia, SpinalTramadol

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaCyclohexanolsHexanolsFatty AlcoholsAlcoholsDimethylaminesMethylaminesLipids

Study Officials

  • Zeki T TEKGUL, MD

    Izmir Bozyaka Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2017

First Posted

April 24, 2017

Study Start

May 2, 2017

Primary Completion

November 11, 2017

Study Completion

November 11, 2017

Last Updated

November 14, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)