NCT06155253

Brief Summary

The goal of this clinical trial is to compare the effects of single-level and bi-level erector spinae plane block in open inguinal hernia repair surgery. The main question it aims to answer are:

  • Whether bi-level ESP block will improve pain control after open inguinal hernia repair surgery
  • Whether bi-level ESP block will improve quality of recovery after open inguinal hernia repair surgery Participants will receive erector spinae plane block, and will be randomised into 2 groups, single-level ESP block and bi-level ESP block, before open hernia repair surgery. They will be followed up after operation for assessment of pain control and quality of recovery.

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

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 19, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2026

Completed
Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

1.8 years

First QC Date

October 19, 2023

Last Update Submit

May 9, 2026

Conditions

Hernia, Inguinal

Keywords

open inguinal hernia repairerector spinae plane blockmulti-levelbi-levelsingle-levelsingle-injection

Outcome Measures

Primary Outcomes (2)

  • Post-operative pain score

    Numeric rating score (11-point scale) will be used to assess pain. (0 = no pain, 10 = worst pain)

    1 day

  • Quality of recovery score (QoR-15)

    This is a validated questionnaire to evaluate the physical, emotional and functional aspects of patients and their abilities to resume usual activities of daily living after surgery and anaesthesia. It ranges from 0-150. Higher score indicates better recovery.

    1 day

Secondary Outcomes (5)

  • Peri-operative fentanyl dosage

    1 day

  • Time to first rescue analgesic

    1 day

  • Rate of motor deficit

    1 day

  • Rate of post-operative urinary retention

    2 days

  • Rate of post-operative nausea and vomiting

    2 days

Study Arms (2)

Single-level ESP group (1ESP)

ACTIVE COMPARATOR

Subjects in 1ESP group will receive a single-shot single-level erector spinae plane block at L1 level under ultrasound guidance immediately before surgery.

Procedure: Erector spinae plane block

Bi-level ESP group (2ESP)

ACTIVE COMPARATOR

Subjects in this group will receive a single-shot single-level erector spinae plane block at T12 and L1 levels under ultrasound guidance immediately before surgery.

Procedure: Erector spinae plane block

Interventions

Erector spinae plane blockPROCEDURE

ESP block is a paraspinal fascial plane block that involves injection of local anesthetic underneath the anterior fascia of the erector spinae muscles. Local anaesthetic mixture (lignocaine 2% with adrenaline, bupivacaine 0.25%) will be delivered with insulated needle in bolus(es) to above-mentioned levels (L1 in 1ESP group, T12 \& L1 in 2ESP group)

Bi-level ESP group (2ESP)Single-level ESP group (1ESP)

Eligibility Criteria

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

You may qualify if:

  • Patients above 18 years old
  • ASA (American Society of Anesthesiologists) class I to III
  • Unilateral open inguinal hernia repair

You may not qualify if:

  • Patient refusal or unable to consent to study
  • Contraindication of ESP block including patient refusal, injection site infection, coagulopathy, hypersensitivity to local anaesthetic
  • Pre-existing chronic pain
  • Alcohol and substance dependence
  • Pre-existing psychiatric diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tin Shui Wai Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Patricia Ip

    HA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

October 19, 2023

First Posted

December 4, 2023

Study Start

January 15, 2024

Primary Completion

October 23, 2025

Study Completion

May 9, 2026

Last Updated

May 13, 2026

Record last verified: 2026-05

Locations

HK(1)