NCT05687981

Brief Summary

The present study will be undertaken to compare the postoperative analgesic effect of 0.25% bupivacaine and 0.5% bupivacaine for unilateral ilioinguinal and Iliohypogastric nerve block after open inguinal hernia repair. Primary outcome: The time to first request for rescue analgesia. Secondary outcome:

  1. 1.The post-operative pain in the form of NRS scores at rest \& during movement at 0, 2, 4, 8, 12, 18 and 24 hours post-procedure.
  2. 2.The total 24 hour opioid consumption.
  3. 3.The incidence of complication related to nerve block (urinary retention, hematoma, hypotension and arrhythmia).
  4. 4.Patient satisfaction

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
90

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2023

Shorter than P25 for early_phase_1

Status
unknown

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

January 1, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

January 9, 2023

Last Update Submit

January 17, 2023

Conditions

Hernia, Inguinal

Keywords

nerve block

Outcome Measures

Primary Outcomes (1)

  • The time to first request for rescue analgesia.

    if score is ≥ 3 analgesia needed

    24 hours

Secondary Outcomes (4)

  • The post-operative pain in the form of NRS.

    at 0, 2, 4, 8, 12, 18 and 24 hours post-procedure.

  • The total 24 hour opioid consumption

    24 hours

  • The incidence of complication related to nerve block

    48 hours

  • Patient satisfaction

    48 hours

Study Arms (2)

Patients will receive 10 ml of 0.5% bupivacaine

ACTIVE COMPARATOR

A 2mg dexamethasone will be added

Drug: Bupivacaine

Patients will receive 10 ml of 0.25% bupivacaine

ACTIVE COMPARATOR

A 2mg dexamethasone will be added

Drug: Dexamethasone

Interventions

BupivacaineDRUG

the use of higher concentration of bupivacaine in ilioinguinal and iliohypogastric nerve block (IINB) might increase the efficacy of postoperative analgesia

Patients will receive 10 ml of 0.5% bupivacaine
DexamethasoneDRUG

2 mg dexamethasone

Patients will receive 10 ml of 0.25% bupivacaine

Eligibility Criteria

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

You may qualify if:

  • Patients between 21 and 60 years age with the American Society of Anesthesiologists' status I or II scheduled for elective primary open inguinal hernia repair

You may not qualify if:

  • Patient refusal.
  • Body mass index (BMI) \>40 kg m2.
  • The presence of skin infection at the injection site.
  • Allergy to local anesthetic drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Bugedo GJ, Carcamo CR, Mertens RA, Dagnino JA, Munoz HR. Preoperative percutaneous ilioinguinal and iliohypogastric nerve block with 0.5% bupivacaine for post-herniorrhaphy pain management in adults. Reg Anesth. 1990 May-Jun;15(3):130-3.

    PMID: 2265166BACKGROUND

  • Kamal K, Jain P, Bansal T, Ahlawat G. A comparative study to evaluate ultrasound-guided transversus abdominis plane block versus ilioinguinal iliohypogastric nerve block for post-operative analgesia in adult patients undergoing inguinal hernia repair. Indian J Anaesth. 2018 Apr;62(4):292-297. doi: 10.4103/ija.IJA_548_17.

    PMID: 29720755BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

BupivacaineDexamethasone

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Mohammad Abduallah

    Tanta University

    STUDY DIRECTOR

Central Study Contacts

Mariam Elkasass

CONTACT

00201024234668mariam160758_pg@med.tanta.ed

Alaa Abohager

CONTACT

00201099220281

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 18, 2023

Study Start

January 1, 2023

Primary Completion

December 1, 2023

Study Completion

January 1, 2024

Last Updated

January 18, 2023

Record last verified: 2023-01