Post Operative PainPhase 4NCT05218733
Ultrasound Guided Erector Spinae Plane Block vs Intrathecal Morphine
A Phase 4 study testing Ultrasound Guided Erector Spinae Plane Block, Intra thecal morphine. and General anesthesia using intravenous fentanyl (1µgm/kg) in people with Post Operative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
Total abdominal hysterectomy (TAH) is a major surgical procedure after which significant post-operative pain and discomfort are anticipated. Abdominal field blocks have been followed for many years and extensively used for pain management following abdominal surgeries such as laparotomies and appendicectomies. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Ultrasound Guided Erector Spinae Plane Block, Intra thecal morphine. and General anesthesia using intravenous fentanyl (1µgm/kg)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2022to 20 Sep 2023
- Phase
- Phase 4
- 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 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index (BMI) 25 to 35kg/m².
- American Society of Anesthesiologist (ASA) physical status I or II.
Who cannot join
- patient's refusal
- Altered mental status
- Known allergy to study drugs (bupivacaine or morphine)
- Local infection at site of puncture.
- Known case with any pulmonary disease
- Known case with Obstructive sleep apnea (OSA)
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- Coagulopathy and /or thrombocytopenia
- Chronic pain
- Severe hepatic or kidney impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Controlled Comparison Between Ultrasound Guided Erector Spinae Plane Block and Intrathecal Morphine
Total abdominal hysterectomy (TAH) is a major surgical procedure after which significant post-operative pain and discomfort are anticipated. Abdominal field blocks have been followed for many years and extensively used for pain management following abdominal surgeries such as laparotomies and appendicectomies. Erector Spinae Plane Block (ESPB)-first recently described for the treatment of thoracic neuropathic pain, is a peri-paravertebral regional anesthesia technique that has since been reported as an effective technique for prevention of postoperative pain in various surgeries. Intrathecal opioid administration is an attractive analgesic technique since the opioid is injected directly into the cerebrospinal fluid, close to the structures of the central nervous system where the opioid acts.
- Conditions
- Post Operative Pain
- Being tested
- Ultrasound Guided Erector Spinae Plane Block, Intra thecal morphine., General anesthesia using intravenous fentanyl (1µgm/kg)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Guided Erector Spinae Plane BlockProcedure or surgery
General anesthesia using intravenous fentanyl (1µgm/kg) and patients will receive bilateral ultrasound-guided ESPB by the an experienced anesthetist in US regional blocks, with each block 20 mL of bupivacaine 0.25%
Intra thecal morphine.Drug
General anesthesia using intravenous fentanyl (1µgm/kg) and patients will receive intra thecal morphine with spinal needle 25G, 3 ml containing 300 ug preservative free morphine
General anesthesia using intravenous fentanyl (1µgm/kg)Drug
Patients will receive general anesthesia using intravenous fentanyl (1µgm/kg)
| Study group | Role | What they receive |
|---|---|---|
| G1 Group: (Erector Spinae Plane Block (ESPB) Group) | Active comparator | Not described Receives: Procedure: Ultrasound Guided Erector Spinae Plane Block |
| G2 Group: (Intra thecal morphine (ITM) Group) | Active comparator | Not described Receives: Drug: Intra thecal morphine. |
| G3 Group: (Control Group) | Other | Not described Receives: Drug: General anesthesia using intravenous fentanyl (1µgm/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time for requirement of first rescue analgesic (min)
The time for requirement of first rescue analgesic (min)
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 posted1 Feb 2022
- Study start15 Feb 2022
- Primary completion20 Sep 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Mamdouh Esmat, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218733
- Sponsor's protocol ID
- IRB 00006379//31-1-2022
- Status last verified
- Oct 2023
- First submitted
- 31 Jan 2022
- Last updated
- 3 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ashoor TM, Esmat IM, Algendy MA, Mohamed NR, Talaat SM, Rabie AH, Elsayed AM. Comparison of the postoperative analgesic efficacy of the ultrasound-guided erector spinae plane block and intrathecal morphine in patients undergoing total abdominal hysterectomy under general anesthesia: a randomized controlled trial. J Anesth. 2025 Apr;39(2):299-310. doi: 10.1007/s00540-025-03466-1. Epub 2025 Mar 6.
PubMed 40047853
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Controlled Comparison Between Ultrasound Guided Erector Spinae Plane Block and Intrathecal Morphine
- ClinicalTrials.gov ID
- NCT05218733
- Acronym / sponsor ID
- IRB 00006379//31-1-2022
- Conditions
- Post Operative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 1 Feb 2022 (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.
Total abdominal hysterectomy (TAH) is a major surgical procedure after which significant post-operative pain and discomfort are anticipated. Abdominal field blocks have been followed for many years and extensively used for pain management following abdominal surgeries such as laparotomies and appendicectomies. Erector Spinae Plane Block (ESPB)-first recently described for the treatment of thoracic neuropathic pain, is a peri-paravertebral regional anesthesia technique that has since been reported as an effective technique for prevention of postoperative pain in various surgeries. Intrathecal opioid administration is an attractive analgesic technique since the opioid is injected directly into the cerebrospinal fluid, close to the structures of the central nervous system where the opioid acts.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| G1 Group: (Erector Spinae Plane Block (ESPB) Group) | Active comparator | Procedure: Ultrasound Guided Erector Spinae Plane Block |
| G2 Group: (Intra thecal morphine (ITM) Group) | Active comparator | Drug: Intra thecal morphine. |
| G3 Group: (Control Group) | Other | Drug: General anesthesia using intravenous fentanyl (1µgm/kg) |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) 25 to 35kg/m².
- American Society of Anesthesiologist (ASA) physical status I or II.
Key exclusion criteria (9 listed)
- patient's refusal
- Altered mental status
- Known allergy to study drugs (bupivacaine or morphine)
- Local infection at site of puncture.
- Known case with any pulmonary disease
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 |
|---|---|---|
| Ultrasound Guided Erector Spinae Plane BlockGeneral anesthesia using intravenous fentanyl (1µgm/kg) and patients will receive bilateral ultrasound-guided ESPB by the an experienced anesthetist in US regional blocks, with each block 20 mL of bupivacaine 0.25% | Procedure or surgery | G1 Group: (Erector Spinae Plane Block (ESPB) Group) |
| Intra thecal morphine.General anesthesia using intravenous fentanyl (1µgm/kg) and patients will receive intra thecal morphine with spinal needle 25G, 3 ml containing 300 ug preservative free morphine | Drug | G2 Group: (Intra thecal morphine (ITM) Group) |
| General anesthesia using intravenous fentanyl (1µgm/kg)Patients will receive general anesthesia using intravenous fentanyl (1µgm/kg) | Drug | G3 Group: (Control Group) |
Primary outcome
The time for requirement of first rescue analgesic (min)
Time frame: 24 hours postoperatively
The time for requirement of first rescue analgesic (min)
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 3 Oct 2023.
- Derived from this study: PubMed 40047853Ashoor TM, Esmat IM, Algendy MA, Mohamed NR, Talaat SM, Rabie AH, Elsayed AM. Comparison of the postoperative analgesic efficacy of the ultrasound-guided erector spinae plane block and intrathecal morphine in patients undergoing total abdominal hysterectomy under general anesthesia: a randomized controlled trial. J Anesth. 2025 Apr;39(2):299-310. doi: 10.1007/s00540-025-03466-1. Epub 2025 Mar 6.
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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 Phase 4 study testing Ultrasound Guided Erector Spinae Plane Block, Intra thecal morphine. and General anesthesia using intravenous fentanyl (1µgm/kg) in people with Post Operative Pain, 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 2 inclusion and 9 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 3 Oct 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The time for requirement of first rescue analgesic (min) (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?
On the ClinicalTrials.gov record for NCT05218733, which also lists 1 linked publication.
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 3 Oct 2023.