NCT06514417

Brief Summary

Ithe study will evaluate the analgesic efficacy of external oblique intercostal block for patients undergoing upper abdominal surgeries

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 17, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 23, 2024

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

10 months

First QC Date

July 17, 2024

Last Update Submit

July 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual analogue pain scale .

    postoperative pain that evaluated by visual analogue pain scale(a scale from 0 to 10 where 0 is interpreted as no pain, 1-4 mild pain, 5-6 moderate pain, 7-10 severe pain)

    24 hours

Secondary Outcomes (1)

  • total perioperative analgesics requirements

    24 hours

Study Arms (2)

external oblique intercostal block

ACTIVE COMPARATOR

receive US-guided external oblique intercostal block after induction

Other: US-guided external oblique intercostal block

No block

NO INTERVENTION

receive postoperative morphine on patient request

Interventions

After induction of general anesthesia, external oblique intercostal block will be performed (8) under ultrasonographic guidance with transportable ultrasound device ( Sonosite ,superficial probe ,14-15 MHz). the patient will be positioned supine, and a linear ultrasound transducer will be placed in the sagittal plane between the midclavicular and anterior axillary lines at the level of sixth rib. 20 ml of bupivacaine 0.25% will be injected between the plane of the external oblique and the intercostal muscles. The drug will be injected after a negative aspiration. The contralateral side block will be performed in a same manner.

external oblique intercostal block

Eligibility Criteria

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

You may qualify if:

  • Selected patients will be more than 21 years old with ASA physical status I \& II scheduled for upper abdominal surgeries

You may not qualify if:

  • Uncooperative patients.
  • Patients who have allergy to any of the used drugs.
  • Patients who are on opioids.
  • Known abuse of alcohol or medication.
  • Local infection at the site of injection or systemic infection.
  • Pregnancy
  • Patients with coagulation disorders or on anticoagulation therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menoufia university

Cairo, Shibin Elkom, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anaethesia

Study Record Dates

First Submitted

July 17, 2024

First Posted

July 23, 2024

Study Start

July 10, 2023

Primary Completion

May 10, 2024

Study Completion

June 10, 2024

Last Updated

July 24, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations