NCT05847842

Brief Summary

In this study, quadratus lumborum block (QLB), transversus abdominis plane (TAP) block, and local anesthetic infiltration will be performed preoperatively in patients who will undergo unilateral inguinal herniorrhaphy operation under general anesthesia. Quality of recovery (QoR-15) score, postoperative acute and chronic pain levels will be evaluated.

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 not_applicable postoperative-pain

Timeline
Completed

Started Apr 2023

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

April 1, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 8, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

April 18, 2023

Last Update Submit

January 18, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quality of recovery assessed by Quality of recovery scale (QoR-15)

    The 15-item quality of recovery (QoR-15) scale is a questionnaire used to evaluate the postoperative recovery quality of patients in the early postoperative stages. The QoR-15 score comprises 15 questions that assess 5 recovery domains, namely, physical comfort, physical independence, psychological support, emotional status, and pain. Each question is scored from 0 to 10 (0 none of the time to 10 all of the time).

    Postoperative 24th hour.

Secondary Outcomes (3)

  • Postoperative pain assessed by Numerical Rating Scale (NRS)

    At the 2nd, 6th, 12th, 24th and 36th hours

  • Postoperative chronic pain assessed by Numerical Rating Scale (NRS)

    Three months later the operation date

  • Postoperative neuropathic pain assessed by Douleur neuropathic pain (DN4) scale.

    Three months later the operation date

Study Arms (3)

Group Q

ACTIVE COMPARATOR

Anterior quadratus lumborum block

Procedure: Anterior quadratus lumborum block

Group T

ACTIVE COMPARATOR

Transversus abdominis plane block

Procedure: Transversus abdominis plane block

Group L

ACTIVE COMPARATOR

Local infiltration

Procedure: Local infiltration

Interventions

20 mL of 0.25% bupivacaine will be given

Group Q

20 mL of 0.25% bupivacaine will be given

Group T

20 mL of 0.25% bupivacaine will be given

Group L

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who will undergo elective unilateral inguinal herniorrhaphy under general anesthesia
  • American Society of Anesthesiology (ASA) physical classification I-III

You may not qualify if:

  • Patients who will undergo laparoscopic surgery
  • Previous inguinal hernia repair surgery
  • A history of opioid use or pain management
  • Coagulopathy or anticoagulant use
  • Patients who have difficulty communicating or who are not cooperative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Eskisehir Osmangazi University Faculty of Medicine

Eskişehir, 26040, Turkey (Türkiye)

Location

Eskisehir Osmangazi Universty

Eskişehir, 26040, Turkey (Türkiye)

Location

Related Publications (1)

  • 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: 34537121BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeHernia, Inguinal

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsHernia, AbdominalHerniaPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Gulay Erdogan Kayhan, Prof Dr

    Eskisehir Osmangazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

April 18, 2023

First Posted

May 8, 2023

Study Start

April 1, 2023

Primary Completion

May 1, 2025

Study Completion

August 1, 2025

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations