Post Operative PainPhase 4NCT05338320
Postoperative Analgesia in Patients Undergoing Elective Lumbar Fusion Operations Under General Anesthesia
A Phase 4 study testing Ultrasound Guided Erector Spinae Plane Block, Intrathecal morphine and General anesthesia using intravenous fentanyl (1µg/kg) in people with Post Operative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
It was proven that intrathecal opioids are considered as an effective means of pain control in several major surgical interventions including spine surgeries. Intrathecal morphine added to a spinal anesthesia reduces acute pain after spine surgeries but has side effects, including dose dependent respiratory… Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Ultrasound Guided Erector Spinae Plane Block, Intrathecal morphine and General anesthesia using intravenous fentanyl (1µg/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
- 10 May 2022to 30 Sep 2024
- 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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index (BMI) 25 to 35 kg/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)
- Coagulopathy and /or thrombocytopenia
- Severe hepatic or kidney impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial for Postoperative Analgesia in Patients Undergoing Elective Lumbar Fusion Operations Under General Anesthesia: Ultrasound Guided Erector Spinae Plane Block Versus Intrathecal Morphine
It was proven that intrathecal opioids are considered as an effective means of pain control in several major surgical interventions including spine surgeries. Intrathecal morphine added to a spinal anesthesia reduces acute pain after spine surgeries but has side effects, including dose dependent respiratory depression, nausea, vomiting, pruritus, and sedation. Ultrasound guided Erector Spinae Plane Block (ESPB) was first described in 2016.Recent case reports suggest a positive effect of ultrasound guided ESPB on pain for multiple indications including lumbar spine fusion and scoliosis surgery, with a very low risk of complications as there are no structures in close proximity at risk of needle injury.
- Conditions
- Post Operative Pain
- Being tested
- Ultrasound Guided Erector Spinae Plane Block, Intrathecal morphine, General anesthesia using intravenous fentanyl (1µg/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 and Ultrasound Guided Erector Spinae Plane Block
Intrathecal morphineDrug
General anesthesia and intrathecal morphine
General anesthesia using intravenous fentanyl (1µg/kg)Other
General anesthesia using intravenous fentanyl (1µg/kg)
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia and Ultrasound Guided Erector Spinae Plane Block | Active comparator | Not described Receives: Procedure: Ultrasound Guided Erector Spinae Plane Block |
| General anesthesia and intrathecal morphine | Active comparator | Not described Receives: Drug: Intrathecal morphine |
| General anesthesia using intravenous fentanyl (1µg/kg) | Other | Not described Receives: Other: General anesthesia using intravenous fentanyl (1µg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first requested rescue analgesia (Minutes).
Time to first requested rescue analgesia (Minutes).
Measured: First 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start10 May 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
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
- NCT05338320
- Sponsor's protocol ID
- FMASU MD 102/2022
- Status last verified
- Oct 2024
- First submitted
- 14 Apr 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ashoor TM, Abdelaal HAS, Elewa GEM, Esmat IM, Rabie AH, Ibrahim AIS, Mohamed AK. Comparison of ultrasound-guided erector spinae plane block to intrathecal morphine for postoperative analgesia in patients undergoing elective lumbar fusion operations under general anesthesia: a randomized controlled trial. BMC Anesthesiol. 2026 Jul 17;26(1):430. doi: 10.1186/s12871-026-04030-4.
PubMed 42464120
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial for Postoperative Analgesia in Patients Undergoing Elective Lumbar Fusion Operations Under General Anesthesia: Ultrasound Guided Erector Spinae Plane Block Versus Intrathecal Morphine
- ClinicalTrials.gov ID
- NCT05338320
- Acronym / sponsor ID
- FMASU MD 102/2022
- 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
- 10 May 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 21 Apr 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.
It was proven that intrathecal opioids are considered as an effective means of pain control in several major surgical interventions including spine surgeries. Intrathecal morphine added to a spinal anesthesia reduces acute pain after spine surgeries but has side effects, including dose dependent respiratory depression, nausea, vomiting, pruritus, and sedation. Ultrasound guided Erector Spinae Plane Block (ESPB) was first described in 2016.Recent case reports suggest a positive effect of ultrasound guided ESPB on pain for multiple indications including lumbar spine fusion and scoliosis surgery, with a very low risk of complications as there are no structures in close proximity at risk of needle injury.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General anesthesia and Ultrasound Guided Erector Spinae Plane Block | Active comparator | Procedure: Ultrasound Guided Erector Spinae Plane Block |
| General anesthesia and intrathecal morphine | Active comparator | Drug: Intrathecal morphine |
| General anesthesia using intravenous fentanyl (1µg/kg) | Other | Other: General anesthesia using intravenous fentanyl (1µg/kg) |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) 25 to 35 kg/m².
- American Society of Anesthesiologist (ASA) physical status I or II.
Key exclusion criteria (8 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 and Ultrasound Guided Erector Spinae Plane Block | Procedure or surgery | General anesthesia and Ultrasound Guided Erector Spinae Plane Block |
| Intrathecal morphineGeneral anesthesia and intrathecal morphine | Drug | General anesthesia and intrathecal morphine |
| General anesthesia using intravenous fentanyl (1µg/kg)General anesthesia using intravenous fentanyl (1µg/kg) | Other | General anesthesia using intravenous fentanyl (1µg/kg) |
Primary outcome
Time to first requested rescue analgesia (Minutes).
Time frame: First 24 hours after surgery.
Time to first requested rescue analgesia (Minutes).
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 15 Oct 2024.
- Derived from this study: PubMed 42464120Ashoor TM, Abdelaal HAS, Elewa GEM, Esmat IM, Rabie AH, Ibrahim AIS, Mohamed AK. Comparison of ultrasound-guided erector spinae plane block to intrathecal morphine for postoperative analgesia in patients undergoing elective lumbar fusion operations under general anesthesia: a randomized controlled trial. BMC Anesthesiol. 2026 Jul 17;26(1):430. doi: 10.1186/s12871-026-04030-4.
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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, Intrathecal morphine and General anesthesia using intravenous fentanyl (1µg/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 8 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 15 Oct 2024. 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?
Time to first requested rescue analgesia (Minutes). (time frame: First 24 hours after surgery.). 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 NCT05338320, 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 15 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.