Effects of magnesium sulfate and pregabalin on postoperative pain in posterior lumbar spinal fusion surgery

Analgesic effects of combination of preoperative intravenous magnesium sulfate and oral pregabalin on postoperative pain in patients undergoing posterior lumbar spinal fusion surgery

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190703044091N1

Enrollment

Registered

2020-09-14

Start date

2020-09-19

Completion date

Unknown

Last updated

2020-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fusion of spine, lumbar region. Fusion of spine, lumbar region

Interventions

Intervention 1: Intervention group 1: Patients in this group (MP) will receive preoperative intravenous infusion of 50 mg/kg magnesium sulfate mixed with 200 ml of normal saline and 300 mg pregabalin

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients between the ages of 18 and 70 years Patients undergoing posterior lumbar spinal fusion surgery

Exclusion criteria

Exclusion criteria: Patients with hepatic dysfunction (transaminases above normal levels) and renal failure (creatinine >150 µmol/l) Cardiac dysfunction (ejection fraction <40) Neurological disorder, myopathy, or history of psychological disorder (e.g. current treatment with antipsychotic and antidepressant medications) Known sensitivity or contraindication to dugs used in the study Preoperative opioid use or regular opioid use due to chronic pain (pain more than 3 months) Preoperative administration of calcium channel blocker Hypermagnesemia

Design outcomes

Primary

Measure	Time frame
Comulative morphine consumption. Timepoint: Baseline (before the operation), 4, 8, 12, 24 hours postoperatively. Method of measurement: Cumulative morphine consumption by assessing the patient controlled analgesia (PCA) pump.	—

Secondary

Measure	Time frame
Visual analogue scale (VAS, 0-10) for pain at rest. Timepoint: Baseline (before the operation), 4, 8, 12, 24 hours postoperatively. Method of measurement: Visual analogue scale.;Posoperative nausea and vomiting (PONV). Timepoint: In 24 hours postoperatively. Method of measurement: Number of episodes patient experiencing nausea and vomiting.;Ramsay sedation scale (RSS). Timepoint: Baseline (before the operation), 4, 8, 12, 24 hours postoperatively. Method of measurement: Patients will be divided into 6 groups according to their level of sedation (from severe agitation to deep coma).	—

Measure

Time frame

Visual analogue scale (VAS, 0-10) for pain at rest. Timepoint: Baseline (before the operation), 4, 8, 12, 24 hours postoperatively. Method of measurement: Visual analogue scale.;Posoperative nausea and vomiting (PONV). Timepoint: In 24 hours postoperatively. Method of measurement: Number of episodes patient experiencing nausea and vomiting.;Ramsay sedation scale (RSS). Timepoint: Baseline (before the operation), 4, 8, 12, 24 hours postoperatively. Method of measurement: Patients will be divided into 6 groups according to their level of sedation (from severe agitation to deep coma).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactRoozbeh Tavanaei

Shahid Beheshti University of Medical Sciences

rtavanaei@sbmu.ac.ir+98 21 2270 1022

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026