Effect of Rectus Sheath Block on Diaphragmatic Function After Elective Upper Abdominal Surgery (Rectus)

Respiratory Effects of Rectus Sheath Block in Patients Undergoing Major Upper Abdominal Surgery.

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Pain
• Intervention / Treatment: Procedure: Rectus Sheath Block

Detailed Description

A major proportion of pain experienced by patients undergoing abdominal surgeries is due to somatic pain signals derived from the abdominal wall. The central portion of anterior abdominal wall components (skin, muscles and parietal peritoneum) is innervated by sensory neurons branching from the anterior rami of spinal nerves T7 to T1. These neurons lie between the rectus abdominis muscle and posterior rectus sheath, and pierce the rectus muscle close to the midline. The tendinous intersections of the rectus muscle do not fuse with the posterior rectus sheath, thereby allowing the injectate to spread cephalo-caudally within this potential space. Rectus sheath (RS) block has been described for any midline abdominal incisions (epigastric and umbilical hernia repairs). As visceral pain becomes attenuated by the 2nd postoperative day, rectus sheath block can also be administered for midline laparotomy.

However, the effects of rectus sheath block analgesia on the respiratory function after abdominal surgery with midline incisions are still under investigation.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beshoy B Bolis, MBBCH; Phone Number: +2 01273774057; Email: bbalbagh@yahoo.com
• Study Contact Backup: Name: Noha Y Mohamed, MD; Phone Number: +2 01001890194; Email: noha.hagagy@gmail.com

Study Locations

• Egypt
  • Assiut Governorate
    • Asyut, Assiut Governorate, Egypt, 715715
      • Recruiting
      • Assiut university main hospital, ICUs
      • Contact: Beshoy B Bolis, MBBCH; Phone Number: +2 01273774057; Email: bbalbagh@yahoo.com
      • Contact: Noha Y Mohamed, MD; Phone Number: +2 088 +2 01001890194; Email: noha.hagagy@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rectus sheath block; Patients will receive ultrasound-guided rectus sheath block' performed after induction of general anesthesia and before surgery.	Procedure: Rectus Sheath Block; Sonar guided RSB will be performed using a 16-G, 8-cm TuohyUpon reaching this potential space, after careful aspiration.; Other Names: RSB
No Intervention: control; Patients will receive general anesthesia .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verbal Rating Scale	Verbal rating pain scale (VRS) (Ranging from 0 to 4), where 0=no pain, 1=mild pain, 2=moderate pain, 3=severe pain and lastly 4 =excruciating pain) will be recorded at rest and upon patient coughing; on admission to PACU (baseline), and 2, 4, 6, 12, and 24h postoperatively.	24 hours Postoperatively
Forced Vital Capacity/L	Measurements of Forced vital capacity (FVC) will be measured by the use of hand-held spirometer (One-flow®, Clement Clarke, U.K). At each assessment, the largest values of FVC will be recorded.	24 hours Postoperatively

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Noha Y Mohamed, MD, Lecturer in anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: September 29, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Acute Pain
• Other Study ID Numbers: 17100594

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No