Postoperative Effects of TAP Block Versus QLB Type 2 Block

NCT ID: NCT03126084

Last Updated: 2017-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-02

Study Completion Date

2017-11-11

Brief Summary

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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

Detailed Description

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Conditions

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Inguinal Hernia Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

1000 mg of intravenous acetaminophen will be administered twice a day

0.25% Bupivacaine

Intervention Type DRUG

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

0.5% Bupivacaine+Glucose

Intervention Type DRUG

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

Tramadol HCl

Intervention Type DRUG

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

Inguinal Hernia Repair

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

1000 mg of intravenous acetaminophen will be administered twice a day

0.5% Bupivacaine+Glucose

Intervention Type DRUG

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

Tramadol HCl

Intervention Type DRUG

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

Inguinal Hernia Repair

Intervention Type PROCEDURE

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

0.25% Bupivacaine

Intervention Type DRUG

10 ml 0.25% bupivacaine will be administered quadratus lumborum muscle and erector spinae muscle

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.

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

1000 mg of intravenous acetaminophen will be administered twice a day

0.5% Bupivacaine+Glucose

Intervention Type DRUG

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

Tramadol HCl

Intervention Type DRUG

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

Inguinal Hernia Repair

Intervention Type PROCEDURE

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

Interventions

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Acetaminophen

1000 mg of intravenous acetaminophen will be administered twice a day

Intervention Type DRUG

0.25% Bupivacaine

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

Intervention Type DRUG

0.5% Bupivacaine+Glucose

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

Intervention Type DRUG

Tramadol HCl

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

Intervention Type DRUG

Inguinal Hernia Repair

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

Intervention Type PROCEDURE

0.25% Bupivacaine

10 ml 0.25% bupivacaine will be administered quadratus lumborum muscle and erector spinae muscle

Intervention Type DRUG

Other Intervention Names

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Postoperative routine analgesia Transversus abdominis plane block Subarachnoid Block Postoperative Salvage Analgesia Quadratus lumborum block type 2

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bozyaka Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zeki T TEKGUL, MD

Role: PRINCIPAL_INVESTIGATOR

Izmir Bozyaka Training and Research Hospital

Locations

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Izmir Bozyaka Training and Research Hospital

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 17179269 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22705951 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20377549 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34537121 (View on PubMed)

Other Identifiers

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ANES-QLB-0609

Identifier Type: -

Identifier Source: org_study_id