Acute PainRectusNCT03725527
Effect of Rectus Sheath Block on Diaphragmatic Function After Elective Upper Abdominal Surgery
A study testing Rectus Sheath Block in people with Acute Pain, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- Rectus Sheath Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Patient refusal.
- Infection at injection site
- Coagulation disorders.
- Allergy to study medications.
- Pregnancy.
- Respiratory tract infection within the last 2 weeks.
- Urgent abdominal surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university main hospital, ICUs
Asyut, Assiut Governorate, 715715
Noha Y Mohamed, MD, +2 01001890194 ext. +2 088, noha.hagagy@gmail.com
Beshoy B Bolis, MBBCH, +2 01273774057, bbalbagh@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Pain
- Being tested
- Rectus Sheath Block
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectus Sheath BlockProcedure or surgery
Also called RSB
Sonar guided RSB will be performed using a 16-G, 8-cm TuohyUpon reaching this potential space, after careful aspiration.
| Study group | Role | What they receive |
|---|---|---|
| Rectus sheath block | Active comparator | Patients will receive ultrasound-guided rectus sheath block' performed after induction of general anesthesia and before surgery. Receives: Procedure: Rectus Sheath Block |
| control | No intervention | Patients will receive general anesthesia . |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours Postoperative
Secondary outcomes (2)
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.
Measured: 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.
Measured: 24 hours Postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start1 May 2020
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Yahia Mohammd El-hagagy, Assiut University
- Investigators
- Noha Y Mohamed, MD, Principal investigator, Lecturer in anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725527
- Sponsor's protocol ID
- 17100594
- Acronym
- Rectus
- Status last verified
- Aug 2025
- First submitted
- 29 Sep 2018
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Effects of Rectus Sheath Block in Patients Undergoing Major Upper Abdominal Surgery.
- ClinicalTrials.gov ID
- NCT03725527
- Acronym / sponsor ID
- Rectus / 17100594
- Conditions
- Acute Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 31 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectus sheath block | Active comparator | Procedure: Rectus Sheath BlockPatients will receive ultrasound-guided rectus sheath block' performed after induction of general anesthesia and before surgery. |
| control | No intervention | –Patients will receive general anesthesia . |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Patient refusal.
- Infection at injection site
- Coagulation disorders.
- Allergy to study medications.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rectus Sheath BlockAlso: RSBSonar guided RSB will be performed using a 16-G, 8-cm TuohyUpon reaching this potential space, after careful aspiration. | Procedure or surgery | Rectus sheath block |
Primary outcome
Diaphragmatic inspiratory amplitude during quiet/deep breathing (DIA)/cm
Time frame: 24 hours Postoperative
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.
2 secondary outcomes
Verbal Rating Scale
Time frame: 24 hours Postoperatively
Forced Vital Capacity/L
Time frame: 24 hours Postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Acute Pain
Not yet recruiting
Testing the Timing and Application of Virtual Reality Distraction During Knee Injections in a VA Pain Clinic
Pain Management, Injection Pain Prevention
Active, not recruiting
Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography
Coronary Artery Disease
Active, not recruiting
Impact of Vitamin C on opioïd Consumption After an Emergency Department Visit for Acute Musculoskeletal Pain
Pain, Acute
Not yet recruiting
Acute Effects of High-Intensity Laser Therapy on Pain, Muscle Stiffness, and Grip Strength in Healthy Adults
Exercise-Induced Muscle Fatigue, Fatigue Recovery
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Noha Y Mohamed, MD principal investigator
Lecturer in anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rectus Sheath Block in people with Acute Pain, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noha Y Mohamed, MD (+2 01001890194, noha.hagagy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic inspiratory amplitude during quiet/deep breathing (DIA)/cm (time frame: 24 hours Postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.