NCT06519708

Brief Summary

This study aims to evaluate the impact of ultrasound-guided erector spinae plane block compared to ultrasound-guided external oblique intercostal plane block regarding management of postoperative acute pain in patients undergoing above Umbilical surgical procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

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

July 21, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

July 25, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2026

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2026

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

July 21, 2024

Last Update Submit

January 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total amount of morphine consumption

    Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient indicates Numeric Pain Rating Scale ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups. A maximum dose of 0.5 mg/kg/24hours of morphine is allowed.

    24 hours postoperatively

Secondary Outcomes (6)

  • Total amount of intraoperative fentanyl consumption

    Intraoperatively

  • Heart rate

    Till the end of surgery

  • Mean arterial blood pressure

    Till the end of surgery

  • Time of first rescue analgesia

    24 hours postoperatively

  • Complications

    24 hours postoperatively

  • +1 more secondary outcomes

Study Arms (2)

Erector Spinae Plane Block

ACTIVE COMPARATOR

Patients will receive an ultrasound-guided erector spinae plane block with the injection of 30 ml bupivacaine 0.25% after induction of general anesthesia.

Drug: Erector Spinae Plane Block

External Oblique Intercostal Plane Block

EXPERIMENTAL

Patients will receive an ultrasound-guided external oblique intercostal plan block Intraoperative with the injection of 30 ml bupivacaine 0.25% after induction of general anesthesia.

Drug: External Oblique Intercostal Plane Block

Interventions

Patients will receive an ultrasound-guided erector spinae plane block with the injection of 30 ml bupivacaine 0.25% after induction of general anesthesia.

Erector Spinae Plane Block

Patients will receive an ultrasound-guided external oblique intercostal plan block Intraoperative with the injection of 30 ml bupivacaine 0.25% after induction of general anesthesia.

External Oblique Intercostal Plane Block

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.
  • Body mass index (BMI): (20-40) kg/m2.
  • American Society of Anesthesiology (ASA) physical status II, III.
  • Type of surgery; unilateral subcostal incision in hepatectomy and nephrectomy.

You may not qualify if:

  • Patient refusal.
  • Subcostal incisions that are crossing the midline or midline incision.
  • Age \<18 years or \>65 years
  • BMI \<20 kg/m2 and \>40 kg/m2
  • Known sensitivity or contraindication to drugs used in the study
  • Contraindication to regional anesthesia e.g. local infection at the site of introduction, pre-existing peripheral neuropathies, and coagulopathy.
  • Pregnancy.
  • Physical status ASA IV
  • patients on chronic analgesic therapy (daily morphine ≥30 mg or equivalent dose of other opioids or tramadol or any medication for neuropathic pain)
  • patients with a history of drug abuse
  • patients with neuropsychiatric diseases; patients with a history of chronic pain syndromes that may enhance sensitivity to pain, for example, fibromyalgia
  • All patients who are going to have severe intra- or post-operative bleeding or will require postoperative mechanical ventilation are also excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, 11796, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Anesthesiology, Intensive Care Unit and Pain Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt.

Study Record Dates

First Submitted

July 21, 2024

First Posted

July 25, 2024

Study Start

July 25, 2024

Primary Completion

January 10, 2026

Study Completion

January 17, 2026

Last Updated

January 21, 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