NCT07251400

Brief Summary

The aim of this study was to compare the effectiveness of ultrasound-guided erector spinae plane block and rectus sheet block on postoperative pain in patients undergoing laparoscopic bilateral hernia repair.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Progress90%
Oct 2025May 2026

Study Start

First participant enrolled

October 15, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 16, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

November 16, 2025

Last Update Submit

April 11, 2026

Conditions

Keywords

postoperative analgesiaerector spinae plane blockinguinal hernia repair

Outcome Measures

Primary Outcomes (1)

  • postoperative pain in patients undergoing laparoscopic bilateral hernia repair

    VAS score

    24 hours after extubation

Secondary Outcomes (1)

  • Total Postoperative Opioid Consumption

    immediately after the surgery

Study Arms (3)

ESB (Erector spinae plane block) group

ACTIVE COMPARATOR

The ESP block will be applied under general anesthesia after skin closure lateral decubitus position. The ultrasound probe will be placed in a longitudinal parasagittal orientation approximately 3 cm lateral to the T7 spinous process. Using the inplane technique, a 22-gauge, 80 mm needle will be advanced craniocaudally, and 30 ml of 0.25% bupivacaine will be injected between the erector spinae muscle and the transverse process. ESPB will be performed bilaterally, with 30 ml of local anesthetic administered to the plane of the erector spinae on each side.

Procedure: Erector spinae plane block

RSB (Bilateral rectus sheath block) group

ACTIVE COMPARATOR

Before recovery from anesthesia, an ultrasound-guided rectus sheath block will be performed after the skin incision is closed. the rectus sheath and the posterior aspect of the rectus abdominis muscle an 80 mm, 22-gauge short-tapered needle will be advanced anterolaterally to medially using in-plane placement with real-time assessment, Once the tip is correctly positioned in the intended plane, 20 mL of a local anesthetic, typically bupivacaine at a concentration of 0.25%, will be administered on each side for effective analgesia.

Procedure: Erector spinae plane block

LA infiltration group

ACTIVE COMPARATOR

Patients who will receive local anesthesia only for surgical incisions will be considered the control group. 20 ml of 0.25% bupivacaine will be applied to the surgical incisions, and no plane block will be performed

Procedure: Erector spinae plane block

Interventions

postoperative analgesia for inguinal hernia repair

Also known as: Bilateral rectus sheath block
ESB (Erector spinae plane block) groupLA infiltration groupRSB (Bilateral rectus sheath block) group

Eligibility Criteria

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

You may qualify if:

  • Patients aged 18 and under 70 years of age
  • ASA I-III

You may not qualify if:

  • Patients with ASA IV,
  • known neurological or psychiatric disorders,
  • asthma or COPD,
  • long-term drug or alcohol abuse,
  • diabetes mellitus,
  • BMI \>35,
  • intellectual disability,
  • contraindications for EPSP or RSB,
  • massive bleeding, coagulopathy
  • those with significant systemic conditions undergoing emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umraniye Education and Research Hospital

Istanbul, Umraniye, 34034, Turkey (Türkiye)

Location

Study Officials

  • Zeliha Alıcıkuş, asc prof

    Umraniye ERH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: * Group 1: ESB (n = 30) * Group 2: RSB (n = 30) * Group 3: LA infiltration (n = 30)
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc. prof. dr

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 26, 2025

Study Start

October 15, 2025

Primary Completion

April 28, 2026

Study Completion (Estimated)

May 30, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations