Postoperative Pain After Spinal Surgery
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGMorphine
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.
DRUGBupivacaine
Local anesthetic used in the block solution (0.25%, 15 mL per side).
DRUGDexamethasone
Adjuvant added to the block solution (8 mg per side) to prolong analgesia.
DRUGMagnesium Sulphate
Adjuvant added to the block solution (300 mg of 10% per side) to prolong analgesia.
Ultrasound-guided injection between the longissimus and iliocostalis muscles at the L3 level.
PROCEDURERetrolaminar Block
Ultrasound-guided injection on the posterior surface of the vertebral lamina at the L3 level, deep to the erector spinae muscles.
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The patient and the outcome assessor are blinded to group allocation. The anesthesiologist performing the block is not blinded.
Intervention model description
Participants are randomized into two parallel groups. Group M receives modified Thoracolumbar Interfascial Plane block, and Group R receives Retrolaminar block, both followed by standardized general anesthesia.
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age between 21 and 65 years * ASA physical status I or II * BMI \< 30 kg/m² * Scheduled for elective two-level lumbar spine surgery (discectomy/decompression) * Expected duration of surgery less than 3 hours * Patient's acceptance and written informed consent
Exclusion criteria
* Infection at block site * Known allergy to used drugs * Coagulation disorder * History of psychiatric illness * Pre-existing neurological deficits * Presence of any metastasis * Previous lumbar spine surgeries * Patients on previous opioid therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total morphine consumption in the first 24 hours postoperatively | 24 hours postoperatively | Cumulative morphine dose (mg) administered as rescue analgesia during the first 24 postoperative hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity by Numerical Rating Scale (NRS) | At 2, 4, 8, 12, 18, and 24 hours postoperatively | Pain intensity assessed using a 10-point Numerical Rating Scale (0 = no pain, 10 = worst pain imaginable) |
| Time to first rescue analgesia | First 24 hours postoperatively | Time from local anesthetic injection until the patient first requests additional pain-relieving medication (NRS \> 3) |
| Block performance time | During block procedure | Time required to perform the block procedure |
| Onset of sensory block | Within 20-30 minutes after injection | Time from local anesthetic injection until loss of sensation in the desired dermatomes |
| Opioid-related side effects | 24 hours postoperatively | Incidence of postoperative nausea and vomiting (PONV) assessed by PONV impact scale (0 = none, 1 = mild, 2 = moderate, 3 = severe), sedation, and respiratory depression |
| Patient satisfaction score | 24 hours postoperatively | Patient satisfaction assessed using a 4-point scale (4 = excellent, 3 = good, 2 = fair, 1 = poor) |
| Incidence of chronic pain | 3 to 6 months postoperatively | 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 of ambulation | First 24 hours postoperatively | Time to first mobilization after surgery |
Countries
Egypt
Contacts
CONTACTMohamed Shehta Mohamed Ali
PRINCIPAL_INVESTIGATORMohamed Shehta Mohamed Ali, M.B.B.CH
Zagazig University
STUDY_CHAIRTarek Gaafar, Prof
Zagazig University
STUDY_CHAIRSanaa Eltohamy, Prof
Zagazig University
STUDY_CHAIRKhadeja Elhossieny, Assist Prof
Zagazig University
Outcome results
None listed