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Inguinal HerniaPhase 4NCT03126084

Postoperative Effects of TAP Block Versus QLB Type 2 Block

A Phase 4 study testing Acetaminophen, 0.25% Bupivacaine and 0.5% Bupivacaine+Glucose in people with Inguinal Hernia and Postoperative Pain, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Inguinal Hernia, Postoperative Pain
What is being tested?
Acetaminophen, 0.25% Bupivacaine and 0.5% Bupivacaine+Glucose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 May 2017to 11 Nov 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Izmir Bozyaka Training and Research Hospital

    Izmir, 35170

Other trials in Turkey (Türkiye)

About this study

Official title: 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

Being tested
Acetaminophen, 0.25% Bupivacaine, 0.5% Bupivacaine+Glucose, Tramadol HCl, Inguinal Hernia Repair
Medical subject headings
Hernia, Inguinal, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcetaminophenDrug

    Also called Postoperative routine analgesia

    1000 mg of intravenous acetaminophen will be administered twice a day

  • 0.25% BupivacaineDrug

    Also called Transversus abdominis plane block

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

  • 0.5% Bupivacaine+GlucoseDrug

    Also called Subarachnoid Block

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

  • Tramadol HClDrug

    Also called Postoperative Salvage Analgesia

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

  • Inguinal Hernia RepairProcedure or surgery

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

  • 0.25% BupivacaineDrug

    Also called Quadratus lumborum block type 2

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

Study groups in NCT03126084
Study groupRoleWhat they receive
TAPActive comparatorPatients 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.
Receives: Drug: Acetaminophen; Drug: 0.25% Bupivacaine; Drug: 0.5% Bupivacaine+Glucose; Drug: Tramadol HCl; Procedure: Inguinal Hernia Repair
QLB2Active comparatorPatients 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.
Receives: Drug: Acetaminophen; Drug: 0.5% Bupivacaine+Glucose; Drug: Tramadol HCl; Procedure: Inguinal Hernia Repair; Drug: 0.25% Bupivacaine
CONTActive comparatorPatients 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.
Receives: Drug: Acetaminophen; Drug: 0.5% Bupivacaine+Glucose; Drug: Tramadol HCl; Procedure: Inguinal Hernia Repair

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Intensity

    Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever

    Measured: 24 hours after surgery

  2. Pain Intensity

    Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever)

    Measured: 2 hours after surgery

  3. Pain Intensity

    Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever

    Measured: 6 hours after surgery

  4. Pain Intensity

    Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever

    Measured: 48 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2017
  2. Study start2 May 2017
  3. Primary completion11 Nov 2017
  4. Study completion11 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03126084
Sponsor's protocol ID
ANES-QLB-0609
Status last verified
Nov 2017
First submitted
20 Apr 2017
Last updated
14 Nov 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 17179269

  • 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.

    PubMed 22705951

  • 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.

    PubMed 20377549

  • 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.

    PubMed 34537121

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Acetaminophen, 0.25% Bupivacaine and 0.5% Bupivacaine+Glucose in people with Inguinal Hernia and Postoperative Pain, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity (time frame: 24 hours after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03126084, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.

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