NCT06661707

Brief Summary

Postoperative pain management is becoming an integral part of anesthesia care. Various techniques of pain relief have been designed. We have designed the study for comparison between ultrasound guided quadratus lumborum (QL) block versus Ultrasound-guided ilioinguinal and iliohypogastric nerves (ILI+IHG) block as regard postoperative pain block and opioid consumption in patients undergoing inguinal hernia repair under general anesthesia.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Status
not yet 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

First Submitted

Initial submission to the registry

October 25, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

October 30, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

October 28, 2024

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

October 25, 2024

Last Update Submit

October 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The time to the first request of analgesia

    visual analogue score ≥3 by giving pethidine (50 mg IV)

    24 hours postoperative

Secondary Outcomes (2)

  • Total doses of analgesia

    24 hours postoperative

  • occurence of side effects

    24 hours postoperative

Study Arms (2)

Quadratus Lumborum block (QL) group

ACTIVE COMPARATOR
Procedure: Sonar guided Quadratus Lumborum block

Ilioinguinal/Iliohypogastric block (ILI/IHG) group

ACTIVE COMPARATOR
Procedure: Sonar guided Ilioinguinal/Iliohypogastric block

Interventions

The probe will be tilted down the lateral abdomen to identify a bright hyperechoic line that represents the middle layer of the thoracolumbar fascia. The needle will be inserted in plane from anterolateral to posteromedial. The needle tip will be placed between the thoracolumbar fascia and the QL muscle, and after negative aspiration, the correct position of the needle will be proved by injection of 5 mL of normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of (0.2 mL/kg of 0.25% bupivacaine per side) will be applied without exceeding the toxic dose 3 mg/kg

Quadratus Lumborum block (QL) group

The ultrasound linear probe will be placed over the anterior superior iliac spine with the superior margin of the transducer pointed directly in an oblique plane toward the umbilicus. The iliohypogastric nerve will be seen medial to the ilioinguinal nerve. The overlying skin will be prepared with antiseptic solution and 21 gauge 120mm Locoplex Sono Tap cannula will be advanced using an in-plane approach from a point just below the inferior border of the transducer toward the ilioinguinal nerve as it lies within the facial plane between the internal abdominal oblique and transverse abdominis muscles. After negative aspiration, (0.2 mL/kg of 0.25% bupivacaine per side) will be injected without exceeding the toxic dose of 3 mg/kg

Ilioinguinal/Iliohypogastric block (ILI/IHG) group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Physical Status: ASA (American society of Anesthesiologists) I - II patients.
  • undergoing inguinal hernia repair

You may not qualify if:

  • Contraindications to QL block \& ILI+IHG nerve block such as; (Infection at site of injection, allergy to local anesthetic drugs.)
  • Refusal of procedure or participation in the study by patients.
  • Psychiatric illness or uncooperative patient.
  • Coagulopathy, use of anticoagulants or antiplatelet therapy.
  • Chronic analgesic users, drug addicts and alcoholic patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

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
Assistant Professor of Anesthesia

Study Record Dates

First Submitted

October 25, 2024

First Posted

October 28, 2024

Study Start

October 30, 2024

Primary Completion

May 30, 2025

Study Completion

May 30, 2025

Last Updated

October 28, 2024

Record last verified: 2024-10