An interventional study of Morphine and Bupivacaine in Postoperative Pain After Spinal Surgery, sponsored by Zagazig University. Recruiting at 1 site in Egypt. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Zagazig University · Not applicable, Interventional, and Treatment
This prospective randomized double-blind study aims to compare the efficacy of modified Thoracolumbar Interfascial Plane (mTLIP) block versus Retrolaminar block for postoperative pain control in patients undergoing elective two-level lumbar spine surgeries. The primary outcome is total morphine consumption in the first 24 postoperative hours.
Pain after lumbar spine surgery arises from disruption of paraspinal muscles, ligaments, and bony structures, with innervation from dorsal rami of spinal nerves. Opioids remain the cornerstone of postoperative analgesia but carry adverse effects. The mTLIP block targets the fascial plane between longissimus and iliocostalis muscles, while the Retrolaminar block deposits local anesthetic on the posterior surface of the vertebral lamina. Both target the dorsal rami. This study will compare both techniques regarding opioid consumption, pain scores, time to first rescue analgesia, block performance metrics, side effects, functional recovery, and patient satisfaction.
Zagazig University is the lead sponsor of 457 studies on the registry; 77 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Preoperative ultrasound-guided mTLIP block at L3 level with 20 mL injectate (Bupivacaine 0.25% 15 mL + dexamethasone 8 mg + magnesium sulphate 300 mg per side), followed by standardized general anesthesia.
Drug: Morphine · Drug: Bupivacaine · Drug: Dexamethasone · Drug: Magnesium Sulphate · Procedure: Modified Thoracolumbar Interfascial Plane Block
Preoperative ultrasound-guided retrolaminar block at L3 level with the same 20 mL injectate composition per side, followed by standardized general anesthesia.
Drug: Morphine · Drug: Bupivacaine · Drug: Dexamethasone · Drug: Magnesium Sulphate · Procedure: Retrolaminar Block
Rescue analgesic administered intravenously at a dose of 0.1-0.2 mg/kg every 2-4 hours as needed for breakthrough pain (NRS \> 3), with a maximum dose of 10 mg per administration.
Also known as: Morphine Sulfate
Local anesthetic used in the block solution (0.25%, 15 mL per side).
Also known as: Bupivacaine Hydrochloride
Adjuvant added to the block solution (8 mg per side) to prolong analgesia.
Also known as: Dexamethasone Sodium Phosphate
Adjuvant added to the block solution (300 mg of 10% per side) to prolong analgesia.
Also known as: Magnesium Sulfate
Ultrasound-guided injection between the longissimus and iliocostalis muscles at the L3 level.
Also known as: mTLIP Block
Ultrasound-guided injection on the posterior surface of the vertebral lamina at the L3 level, deep to the erector spinae muscles.
Also known as: RLB
Total morphine consumption in the first 24 hours postoperatively
Cumulative morphine dose (mg) administered as rescue analgesia during the first 24 postoperative hours
Time frame: 24 hours postoperatively
Pain intensity by Numerical Rating Scale (NRS)
Pain intensity assessed using a 10-point Numerical Rating Scale (0 = no pain, 10 = worst pain imaginable)
Time frame: At 2, 4, 8, 12, 18, and 24 hours postoperatively
Time to first rescue analgesia
Time from local anesthetic injection until the patient first requests additional pain-relieving medication (NRS \> 3)
Time frame: First 24 hours postoperatively
Block performance time
Time required to perform the block procedure
Time frame: During block procedure
Onset of sensory block
Time from local anesthetic injection until loss of sensation in the desired dermatomes
Time frame: Within 20-30 minutes after injection
Opioid-related side effects
Incidence of postoperative nausea and vomiting (PONV) assessed by PONV impact scale (0 = none, 1 = mild, 2 = moderate, 3 = severe), sedation, and respiratory depression
Time frame: 24 hours postoperatively
Patient satisfaction score
Patient satisfaction assessed using a 4-point scale (4 = excellent, 3 = good, 2 = fair, 1 = poor)
Time frame: 24 hours postoperatively
Incidence of chronic pain
Chronic pain will be assessed at 3 months postoperatively via a structured follow-up (telephone interview or outpatient clinic visit). Patients will be asked whether they experience persistent or recurrent pain at or around the surgical site lasting more than 3 months after surgery. Responses will be recorded as "Yes" or "No," and the proportion of patients answering "Yes" will be reported as the incidence of chronic pain, according to the IASP definition (pain persisting or recurring for more than 3 months).
Time frame: 3 to 6 months postoperatively
Time of ambulation
Time to first mobilization after surgery
Time frame: First 24 hours postoperatively
Plan to share: No — Individual participant data will not be shared due to privacy and ethical restrictions.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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