NCT06092073

Brief Summary

The aim of this study is to evaluate the efficacy and safety bilateral recto-intercostal fascial plane block (RIFPB) in epigastric hernia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

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 12, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

October 21, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

October 12, 2023

Last Update Submit

January 28, 2026

Conditions

Epigastric HerniaAnalgesiaRecto-intercostal Fascial Plane Block

Outcome Measures

Primary Outcomes (1)

  • Time to the 1st rescue analgesia

    Rescue analgesia in the form of 3 mg of IV morphine will be given if the numeric rating scale (NRS) score \> 3. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").

    24 hours postoperatively

Secondary Outcomes (6)

  • Total morphine consumption in the 1st 24hr

    24 hours postoperatively

  • Pain score

    24 hours postoperatively

  • Intraoperative fentanyl consumption

    Intraoperatively.

  • Intraoperative mean arterial pressure

    Till the end of surgery.

  • Intraoperative heart rate

    Till the end of surgery.

  • +1 more secondary outcomes

Study Arms (2)

RIFPB group

EXPERIMENTAL

Patients will receive bilateral Recto-Intercostal Fascial Plane Block (RIFPB) using 20 mL of bupivacaine 0.25% on each side.

Procedure: recto-intercostal fascial plane blockDrug: bupivacaine

Control group

NO INTERVENTION

Patients will not receive the block.

Interventions

bupivacaineDRUG

bupivacaine 0.25%

RIFPB group
recto-intercostal fascial plane blockPROCEDURE

Patients will receive bilateral recto-intercostal fascial plane block using 20 mL of bupivacaine 0.25% on each side.

RIFPB group

Eligibility Criteria

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

You may qualify if:

  • Age 18-65 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status I-II.
  • Scheduled for elective epigastric hernia repair.

You may not qualify if:

  • Obese patients with body mass index (BMI) \>35 kg/m2.
  • Patients with a large hernia containing bowel.
  • Patients with local anesthetic allergy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

First Submitted

October 12, 2023

First Posted

October 23, 2023

Study Start

October 21, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations

EG(1)