Efficacy of Adding Intrathecal Morphine to Erector Spinae Plane Block for Postoperative Analgesia After Midline Laparotomy
- Sponsor
- Sohag University
- Study ID
- NCT07720739
- Status
- Recruiting
Conditions
- Midline Laparotomy
- Postoperative Pain
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Not accepted
Interventions
- Intrathecal Morphine — DRUGAdministration 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 Block — PROCEDUREBilateral 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 Details
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.
Key Dates
- First listed
- Jul 22, 2026
- Start date
- Jul 31, 2026
- Status verified
- Jun 2026
- Primary completion
- Nov 30, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 75 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Intrathecal morphine aloneDrug: 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.
- Active Comparator: Bilateral 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.
- Experimental: Intrathecal morphine + Bilateral 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).
Primary Outcome Measure
Time to First Rescue Analgesia [ Time Frame: Up to 48 hours postoperatively. ]
Related Studies
- Ketamine in Patients Undergoing TEVAR Procedures Receiving NCIPHASE2 · Recruiting · Sam Tyagi · Lexington, Kentucky
- Virtual Reality and Olfactory Stimuli Multimodal Intervention to Reduce Post-Operative Pain and Anxiety in Patients Undergoing Cardiothoracic SurgeryRecruiting · Massachusetts General Hospital · Boston, Massachusetts
- A Clinical Trial of Intravenous Lidocaine After Spinal Surgery to Prevent Delirium and Reduce PainPHASE3 · Recruiting · University of California, San Francisco · San Francisco, California
- Use of a Vibration Tool for Postoperative Pain Control in Distal Radius FracturesNot Yet Recruiting · Northwestern University · Chicago, Illinois