NCT03725527

Brief Summary

This study will be undertaken to investigate the respiratory and analgesic effects of ultrasound guided rectus sheath block analgesia after elective abdominal surgery with midline incision.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

September 29, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
1.5 years until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

5.7 years

First QC Date

September 29, 2018

Last Update Submit

August 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diaphragmatic inspiratory amplitude during quiet/deep breathing (DIA)/cm

    The ultrasonic measurements of diaphragmatic motion will be attained at the posterior surface of the diaphragm. From the tracings on M-mode, the distance between echogenic lines (DIA) in centimeters and diaphragmatic inspiratory/expiratory velocity in centimeters/second during quiet, deep, and sniff breathing will be measured on the frozen images.

    24 hours Postoperative

Secondary Outcomes (2)

  • Verbal Rating Scale

    24 hours Postoperatively

  • Forced Vital Capacity/L

    24 hours Postoperatively

Study Arms (2)

Rectus sheath block

ACTIVE COMPARATOR

Patients will receive ultrasound-guided rectus sheath block' performed after induction of general anesthesia and before surgery.

Procedure: Rectus Sheath Block

control

NO INTERVENTION

Patients will receive general anesthesia .

Interventions

Sonar guided RSB will be performed using a 16-G, 8-cm TuohyUpon reaching this potential space, after careful aspiration.

Also known as: RSB
Rectus sheath block

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18-50 years.
  • Sex: both males and females.
  • BMI\< 30kg/m2.
  • ASA physical status: 1, II and III.
  • Elective abdominal surgery with midline incisions.

You may not qualify if:

  • Patient refusal.
  • Infection at injection site
  • Coagulation disorders.
  • Allergy to study medications.
  • Pregnancy.
  • Respiratory tract infection within the last 2 weeks.
  • Urgent abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university main hospital, ICUs

Asyut, Assiut Governorate, 715715, Egypt

RECRUITING

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Noha Y Mohamed, MD

    Lecturer in anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noha Y Mohamed, MD

CONTACT

Beshoy B Bolis, MBBCH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and intensive care, faculty of medicine, Assiut university.

Study Record Dates

First Submitted

September 29, 2018

First Posted

October 31, 2018

Study Start

May 1, 2020

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

September 4, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations