UltrasoundNCT06837506
Ultrasound Guided Rectus Sheath Block Versus Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Open Total Abdominal Hysterectomy
A study testing Rectus sheath block and Intrathecal morphine in people with Ultrasound and Rectus Sheath Block, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to compare the effectiveness and safety of ultrasound-guided rectus sheath block versus intrathecal morphine for postoperative analgesia in patients undergoing open total abdominal hysterectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Ultrasound, Rectus Sheath Block, Intrathecal Morphine
- What is being tested?
- Rectus sheath block and Intrathecal morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 - 65 years old.
- American Society of Anesthesiologists (ASA) physical status (I -II).
- Patients undergoing open total abdominal hysterectomy.
Who cannot join
- Hepatic, renal, or cardiac disease.
- Any known allergy to local anesthetic.
- Physical or mental conditions which may vague measuring postoperative pain following surgery.
- History of chronic use of analgesic as nonsteroidal anti-inflammatory drugs (NSAIDs) or central nervous system (CNS) depressants as antiepileptic, and bleeding disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Rectus Sheath Block Versus Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Open Total Abdominal Hysterectomy: A Randomized Trial
This study aims to compare the effectiveness and safety of ultrasound-guided rectus sheath block versus intrathecal morphine for postoperative analgesia in patients undergoing open total abdominal hysterectomy.
Read the detailed description
Effective postoperative analgesia is crucial for enhancing recovery and patient satisfaction following major surgical procedures, such as total abdominal hysterectomy (TAH).
Rectus sheath block (RSB), an ultrasound-guided regional anesthesia technique, involves the injection of local anesthetic into the rectus sheath, providing analgesia to the anterior abdominal wall. RSB is used to block the sensory nerves of the anterior abdominal wall and thereby contributing to pain relief after lower abdominal surgeries.
Intrathecal morphine (ITM) provides a highly effective method of analgesia by delivering the medication directly into the cerebrospinal fluid (CSF).
- Conditions
- Ultrasound, Rectus Sheath Block, Intrathecal Morphine, Postoperative Analgesia, Total Abdominal Hysterectomy
- Being tested
- Rectus sheath block, Intrathecal morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectus sheath blockDrug
Also called Bupivacaine 0.25%
Patients will receive rectus sheath block (20 ml bilaterally, bupivacaine 0.25%) after induction of general anesthesia.
Intrathecal morphineDrug
Patients will receive 150 µg intrathecal morphine after induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Rectus sheath block group | Experimental | Patients will receive rectus sheath block (20 ml bilaterally, bupivacaine 0.25%) after induction of general anesthesia. Receives: Drug: Rectus sheath block |
| Intrathecal morphine group | Experimental | Patients will receive 150 µg intrathecal morphine after induction of general anesthesia. Receives: Drug: Intrathecal morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Morphine will be administered if the visual analog scale (VAS) score is ≥ 4.
Measured: 24 hours postoperatively
Secondary outcomes (6)
Time to the first request for the rescue analgesia
Time to the first request for the rescue analgesia (time from the end of surgery till first dose of morphine administrated)
Measured: 24 hours postoperatively
Degree of pain
Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed after surgery over 24 hour using VAS scale at (post-anesthesia care unit, 2, 4, 6, 12, 18, and 24 h).
Measured: 24 hours postoperatively
Degree of sedation
Sedation will be assessed using Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S): (5 Alert: Responds readily to name spoken in normal tone, 4: Lethargic response to name spoken in normal tone, 3: Responds only after name is called loudly and/or repeatedly, 2: Responds only after mild prodding or shaking ,1: Responds only after painful trapezius squeeze,0: Does not respond to painful trapezius squeeze).
Measured: Intraoperatively
Degree of patient satisfaction
The degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).
Measured: 24 hours postoperatively
Time of hospital discharge
Time of hospital discharge will be recorded from admission till the discharge from hospital.
Measured: 28 days postoperatively
Incidence of adverse events
Incidence of adverse events such as hematoma, nerve damage or neuropathy, bradycardia, hypotension, nausea, vomiting, pruritis, or any other complication 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 posted20 Feb 2025
- Study start20 Feb 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Ahmed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837506
- Sponsor's protocol ID
- FMASU R03/2024/2025
- Status last verified
- Aug 2026
- First submitted
- 15 Feb 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Rectus Sheath Block Versus Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Open Total Abdominal Hysterectomy: A Randomized Trial
- ClinicalTrials.gov ID
- NCT06837506
- Acronym / sponsor ID
- FMASU R03/2024/2025
- Conditions
- Ultrasound, Rectus Sheath Block, Intrathecal Morphine, Postoperative Analgesia, Total Abdominal Hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 20 Feb 2025 (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 aims to compare the effectiveness and safety of ultrasound-guided rectus sheath block versus intrathecal morphine for postoperative analgesia in patients undergoing open total abdominal hysterectomy.
Detailed description
Effective postoperative analgesia is crucial for enhancing recovery and patient satisfaction following major surgical procedures, such as total abdominal hysterectomy (TAH).
Rectus sheath block (RSB), an ultrasound-guided regional anesthesia technique, involves the injection of local anesthetic into the rectus sheath, providing analgesia to the anterior abdominal wall. RSB is used to block the sensory nerves of the anterior abdominal wall and thereby contributing to pain relief after lower abdominal surgeries.
Intrathecal morphine (ITM) provides a highly effective method of analgesia by delivering the medication directly into the cerebrospinal fluid (CSF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectus sheath block group | Experimental | Drug: Rectus sheath blockPatients will receive rectus sheath block (20 ml bilaterally, bupivacaine 0.25%) after induction of general anesthesia. |
| Intrathecal morphine group | Experimental | Drug: Intrathecal morphinePatients will receive 150 µg intrathecal morphine after induction of general anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 18 - 65 years old.
- American Society of Anesthesiologists (ASA) physical status (I -II).
- Patients undergoing open total abdominal hysterectomy.
Key exclusion criteria (4 listed)
- Hepatic, renal, or cardiac disease.
- Any known allergy to local anesthetic.
- Physical or mental conditions which may vague measuring postoperative pain following surgery.
- History of chronic use of analgesic as nonsteroidal anti-inflammatory drugs (NSAIDs) or central nervous system (CNS) depressants as antiepileptic, and bleeding disorders.
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: Bupivacaine 0.25%Patients will receive rectus sheath block (20 ml bilaterally, bupivacaine 0.25%) after induction of general anesthesia. | Drug | Rectus sheath block group |
| Intrathecal morphinePatients will receive 150 µg intrathecal morphine after induction of general anesthesia. | Drug | Intrathecal morphine group |
Primary outcome
Total morphine consumption
Time frame: 24 hours postoperatively
Morphine will be administered if the visual analog scale (VAS) score is ≥ 4.
6 secondary outcomes
Time to the first request for the rescue analgesia
Time frame: 24 hours postoperatively
Degree of pain
Time frame: 24 hours postoperatively
Degree of sedation
Time frame: Intraoperatively
Degree of patient satisfaction
Time frame: 24 hours postoperatively
Time of hospital discharge
Time frame: 28 days postoperatively
Incidence of adverse events
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 and Intrathecal morphine in people with Ultrasound and Rectus Sheath Block, run by Ain Shams 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 12 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption (time frame: 24 hours postoperatively). 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 12 Aug 2026.