Postoperative PainNCT07720739
Efficacy of Adding Intrathecal Morphine to Erector Spinae Plane Block for Postoperative Analgesia After Midline Laparotomy
A study testing Intrathecal Morphine and Erector Spinae Plane Block in people with Postoperative Pain and Midline Laparotomy, run by Sohag University at 1 site in Egypt.
Trial summary
This study evaluates whether combining two distinct pain-relief techniques-a peripheral nerve block called the Erector Spinae Plane Block (ESPB) and a low-dose spinal medication injection called Intrathecal Morphine (ITM)-provides better postoperative pain management for adult patients undergoing major midline… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain, Midline Laparotomy
- What is being tested?
- Intrathecal Morphine and Erector Spinae Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2026to Dec 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 60 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria Patients scheduled to undergo elective or emergency midline exploratory laparotomy.
American Society of Anesthesiologists (ASA) physical status I, II, or III. Intact cognitive ability to comprehend study procedures, use the Numeric Rating Scale (NRS) accurately, and provide informed consent.
Exclusion Criteria Contraindications to regional or neuraxial anesthesia (e.g., patient refusal, localized infection at needle insertion sites, known coagulopathy (INR >1.5 or platelet count <80,000/\mu L), or un-pausable therapeutic anticoagulation).
Known allergy or severe hypersensitivity to local anesthetics or morphine. Chronic pain conditions requiring daily opioid consumption for >3 months preoperatively.
Documented history of substance use disorder. Severe chronic respiratory disease (e.g., COPD requiring home oxygen therapy, or severe obstructive sleep apnea not managed with CPAP).
Neurological or psychiatric conditions that compromise sensory perception or communication.
Surgical incisions planned to extend significantly past the midline. Severe spinal deformities or a history of spinal surgery at the targeted block/injection interspaces.
Concurrent enrollment in any other interventional clinical trial.
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
Sohag University Hospital
Sohag
Ahmed Samir Abdelmonaem, Resident doctor, +201022447409, ahmed.abdelmonem@med.sohag.edu.eg
About this study
Official title: Efficacy of Adding Intrathecal Morphine to Erector Spinae Plane Block for Postoperative Analgesia After Midline Laparotomy: A Prospective Randomized Study
This study evaluates whether combining two distinct pain-relief techniques-a peripheral nerve block called the Erector Spinae Plane Block (ESPB) and a low-dose spinal medication injection called Intrathecal Morphine (ITM)-provides better postoperative pain management for adult patients undergoing major midline abdominal surgery (laparotomy) compared to using either technique alone. The main goal is to see if this combination improves pain control and reduces the total amount of opioids required by patients within the first 48 hours after surgery.
- Conditions
- Postoperative Pain, Midline Laparotomy
- Being tested
- Intrathecal Morphine, Erector Spinae Plane Block
- Keywords
- Erector Spinae Plane Block, Intrathecal morphine, Opioid-sparing, Abdominal surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal MorphineDrug
Also called ITM, Spinal Morphine
Administration of a single-shot intrathecal injection containing hyperbaric bupivacaine combined with preservative-free morphine (ITM) during spinal anesthesia prior to the surgical incision."
Erector Spinae Plane BlockProcedure or surgery
Also called ESBP, Ultrasound-guided ESPB
Bilateral ultrasound-guided erector spinae plane block performed at the T8-T10 level using a local anesthetic solution (such as bupivacaine or ropivacaine) injected deep to the erector spinae muscle fascia for postoperative abdominal analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal morphine alone | Active comparator | Drug: Intrathecal Morphine (ITM) Under sterile conditions preoperatively, a 25-gauge spinal needle is introduced at the L3-L4 or L2-L3 interspace. A 1.0 mL solution containing 100 µg of preservative-free morphine (diluted with 0.9% normal saline) is injected intrathecally upon free CSF flow. No ESPB is performed. Receives: Drug: Intrathecal Morphine |
| Bilateral Erector Spinae Plane Block | Active comparator | Procedure: Bilateral Erector Spinae Plane Block Preoperatively, using a high-frequency linear ultrasound probe at the T8 vertebral level, an echogenic needle is inserted in-plane deep to the erector spinae muscle and superficial to the transverse process. After negative aspiration, 20 mL of 0.25% isobaric bupivacaine is injected. The procedure is repeated on the opposite side. No ITM is performed. Receives: Procedure: Erector Spinae Plane Block |
| Intrathecal morphine + Bilateral Erector Spinae Plane Block | Experimental | Combination Regimen Patients receive both interventions preoperatively. The bilateral T8 ESPB (20 mL 0.25% bupivacaine per side) is performed first in the lateral decubitus position, followed immediately by the lumbar L2-L3 or L3-L4 ITM injection (100 mcg preservative-free morphine). Receives: Drug: Intrathecal Morphine; Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Rescue Analgesia
Duration of time (in minutes/hours) elapsed from PACU admission to the patient's first request for an IV morphine rescue bolus.
Measured: Up to 48 hours postoperatively.
Postoperative Pain Intensity
Numeric Rating Scale (NRS) score ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: At rest and during a standardized cough at 0, 2, 4, 6, 12, 24, and 48 hours postoperatively.
Cumulative Opioid Consumption
Total postoperative intravenous rescue morphine consumed, calculated and recorded in Morphine Milligram Equivalents (MME).
Measured: Up to 48 hours postoperatively.
Secondary outcomes (6)
Time to First Ambulation
Time taken (in hours) from the end of surgery until the patient is able to walk more than 5 meters with assistance.
Measured: Up to hospital discharge (typically up to 7 days).
Time to Readiness for PACU Discharge
Time in minutes from PACU admission until the patient achieves a modified Aldrete score \ge9.
Measured: Within the first 24 hours postoperatively.
Incidence of Adverse Events
Presence or absence (percentages) of respiratory depression (RR <8/min or SpO_2 <90% on room air), PONV requiring treatment, or pruritus requiring treatment.
Measured: Up to 48 hours postoperatively.
Patient Satisfaction with Pain Management
Score on a 5-point Likert scale ranging from 1 (Dissatisfied) to 5 (Very Satisfied).
Measured: Assessed at 48 hours postoperatively.
Quality of Recovery
Total score obtained from the 9-item Quality of Recovery (QoR-9) questionnaire.
Measured: Postoperative Day 1 (approximately 24 hours).
Healthcare Utilization
Total length of hospital stay measured in days.
Measured: From day of surgery to hospital discharge (up to 30 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
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 Postoperative PainStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Samir Abdelmonaem, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720739
- Sponsor's protocol ID
- Soh-Med-26-6-13MS
- Status last verified
- Jun 2026
- First submitted
- 19 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside the research team to protect patient privacy, maintain strict data confidentiality regarding clinical interventions, and comply with institutional data management policies.
Publications
Beverly A, Kaye AD, Ljungqvist O, Urman RD. Essential Elements of Multimodal Analgesia in Enhanced Recovery After Surgery (ERAS) Guidelines. Anesthesiol Clin. 2017 Jun;35(2):e115-e143. doi: 10.1016/j.anclin.2017.01.018.
PubMed 28526156
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adding Intrathecal Morphine to Erector Spinae Plane Block for Postoperative Analgesia After Midline Laparotomy: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07720739
- Acronym / sponsor ID
- Soh-Med-26-6-13MS
- Conditions
- Postoperative Pain, Midline Laparotomy
- Keywords
- Erector Spinae Plane Block, Intrathecal morphine, Opioid-sparing, Abdominal surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Jul 2026 (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 evaluates whether combining two distinct pain-relief techniques-a peripheral nerve block called the Erector Spinae Plane Block (ESPB) and a low-dose spinal medication injection called Intrathecal Morphine (ITM)-provides better postoperative pain management for adult patients undergoing major midline abdominal surgery (laparotomy) compared to using either technique alone. The main goal is to see if this combination improves pain control and reduces the total amount of opioids required by patients within the first 48 hours after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intrathecal morphine alone | Active comparator | Drug: Intrathecal MorphineDrug: Intrathecal Morphine (ITM) Under sterile conditions preoperatively, a 25-gauge spinal needle is introduced at the L3-L4 or L2-L3 interspace. A 1.0 mL solution containing 100 µg of preservative-free morphine (diluted with 0.9% normal saline) is injected intrathecally upon free CSF flow. No ESPB is performed. |
| Bilateral Erector Spinae Plane Block | Active comparator | Procedure: Erector Spinae Plane BlockProcedure: Bilateral Erector Spinae Plane Block Preoperatively, using a high-frequency linear ultrasound probe at the T8 vertebral level, an echogenic needle is inserted in-plane deep to the erector spinae muscle and superficial to the transverse process. After negative aspiration, 20 mL of 0.25% isobaric bupivacaine is injected. The procedure is repeated on the opposite side. No ITM is performed. |
| Intrathecal morphine + Bilateral Erector Spinae Plane Block | Experimental | Drug: Intrathecal Morphine, Procedure: Erector Spinae Plane BlockCombination Regimen Patients receive both interventions preoperatively. The bilateral T8 ESPB (20 mL 0.25% bupivacaine per side) is performed first in the lateral decubitus position, followed immediately by the lumbar L2-L3 or L3-L4 ITM injection (100 mcg preservative-free morphine). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Intrathecal MorphineAlso: ITM, Spinal MorphineAdministration of a single-shot intrathecal injection containing hyperbaric bupivacaine combined with preservative-free morphine (ITM) during spinal anesthesia prior to the surgical incision." | Drug | Intrathecal morphine + Bilateral Erector Spinae Plane Block, Intrathecal morphine alone |
| Erector Spinae Plane BlockAlso: ESBP, Ultrasound-guided ESPBBilateral ultrasound-guided erector spinae plane block performed at the T8-T10 level using a local anesthetic solution (such as bupivacaine or ropivacaine) injected deep to the erector spinae muscle fascia for postoperative abdominal analgesia. | Procedure or surgery | Bilateral Erector Spinae Plane Block, Intrathecal morphine + Bilateral Erector Spinae Plane Block |
Primary outcome
Time to First Rescue Analgesia
Time frame: Up to 48 hours postoperatively.
Duration of time (in minutes/hours) elapsed from PACU admission to the patient's first request for an IV morphine rescue bolus.
Postoperative Pain Intensity
Time frame: At rest and during a standardized cough at 0, 2, 4, 6, 12, 24, and 48 hours postoperatively.
Numeric Rating Scale (NRS) score ranging from 0 (no pain) to 10 (worst imaginable pain).
Cumulative Opioid Consumption
Time frame: Up to 48 hours postoperatively.
Total postoperative intravenous rescue morphine consumed, calculated and recorded in Morphine Milligram Equivalents (MME).
6 secondary outcomes
Time to First Ambulation
Time frame: Up to hospital discharge (typically up to 7 days).
Time to Readiness for PACU Discharge
Time frame: Within the first 24 hours postoperatively.
Incidence of Adverse Events
Time frame: Up to 48 hours postoperatively.
Patient Satisfaction with Pain Management
Time frame: Assessed at 48 hours postoperatively.
Quality of Recovery
Time frame: Postoperative Day 1 (approximately 24 hours).
Healthcare Utilization
Time frame: From day of surgery to hospital discharge (up to 30 days).
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 22 Jul 2026.
- Background: PubMed 28526156Beverly A, Kaye AD, Ljungqvist O, Urman RD. Essential Elements of Multimodal Analgesia in Enhanced Recovery After Surgery (ERAS) Guidelines. Anesthesiol Clin. 2017 Jun;35(2):e115-e143. doi: 10.1016/j.anclin.2017.01.018.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside the research team to protect patient privacy, maintain strict data confidentiality regarding clinical interventions, and comply with institutional data management policies.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal Morphine and Erector Spinae Plane Block in people with Postoperative Pain and Midline Laparotomy, run by Sohag 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?
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 22 Jul 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Rescue Analgesia (time frame: Up to 48 hours postoperatively.). The study lists 3 primary outcomes in all. 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 NCT07720739, 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 22 Jul 2026.