NCT06862609

Brief Summary

Inguinal hernia repair is one of the most commonly performed surgical procedures. It is generally performed under regional anesthesia techniques, such as local anesthesia, peripheral nerve blocks, or neuraxial anesthesia (spinal or epidural anesthesia), or under general anesthesia. Despite various available analgesic regimens, numerous studies have demonstrated that postoperative pain control remains inadequate. Opioids, nonsteroidal anti-inflammatory drugs, and analgesics are frequently used for postoperative pain management. However, these medications are associated with uncertain efficacy and undesirable side effects. Pain is a critical factor in the postoperative period, contributing to delayed ambulation and paralytic ileus, ultimately hindering early discharge.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
1mo left

Started Mar 2025

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress98%
Mar 2025Jun 2026

First Submitted

Initial submission to the registry

February 25, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 6, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

March 23, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

February 25, 2025

Last Update Submit

March 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is the QoR-15 score (0-150 point) at 24 hours postoperatively.

    The primary outcome is the QoR-15 score (0-150 point) at 24 hours postoperatively.

    24 hours

Study Arms (2)

control group

OTHER

All patients will receive IV paracetamol (1 g, 3×1) and IV tenoxicam (20 mg, 2×1). Rescue analgesia (IV tramadol 1 mg/kg) will be administered if Numerical rating scale scores are ≥3. IV ondansetron (4 mg) will be given for nausea and vomiting.

Other: Quadro iliac plane block

Quadro iliac plane block

ACTIVE COMPARATOR

All patients will receive IV paracetamol (1 g, 3×1) and IV tenoxicam (20 mg, 2×1). Rescue analgesia (IV tramadol 1 mg/kg) will be administered if Numerical rating scale scores are ≥3. IV ondansetron (4 mg) will be given for nausea and vomiting. Group Q patients will receive quadro iliac plane block in addition to standard analgesia.

Other: Control group

Interventions

Patients in Group Q will be placed in the lateral position. A low-frequency convex transducer and a 100-mm block needle will be used. Following sterilization, the transducer will be placed parasagittally at the distal attachment of the quadratus lumborum muscle to the iliac crest. The iliac crest and quadratus lumborum muscle will be visualized, with the erector spinae muscle above and the psoas major muscle below. Using an in-plane technique, the needle will be directed toward the iliac crest. After confirmation with 5 mL of isotonic sodium chloride, 20 mL of 0.25% bupivacaine will be injected incrementally with intermittent aspiration. The same procedure will be applied to the other party. A total of 40 mL of 0.25% bupivacaine will be administered.

control group

All patients will receive IV paracetamol (1 g, 3×1) and IV tenoxicam (20 mg, 2×1).

Quadro iliac plane block

Eligibility Criteria

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

You may qualify if:

  • Patients aged 18-65 years
  • Undergoing elective,
  • unilateral laparoscopic inguinal hernia repair
  • Receiving general anesthesia

You may not qualify if:

  • Patients who refuse to provide consent
  • Patients with contraindications to regional anesthesia
  • Patients with impaired consciousness
  • Patients with coagulopathy
  • Patients with infections at the block site
  • Emergency cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya City Hospital

Konya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist, M.D., Department of members Anesthesiology and Reanimation, Konya City Hospital, M.D

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 6, 2025

Study Start

March 23, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations