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The effects of intrathecal magnesium and fentanyl added to bupivacaine on postoperative analgesic requirement in Patients undergoing lower limb orthopedic surgery

Comparison of Postoperative Analgesic Effect of intrathecal magnesium and fentanyl added to bupivacaine in Patients undergoing lower limb orthopedic surgery

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000757011
Enrollment
90
Registered
2010-09-14
Start date
2010-08-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Objective :Magnesium has been suggested that NMDA (N-methyl D-aspartate)receptor antagonists induce preemptive analgesia when administrated before tissue injury occurs, thus decreasing the subsequent sensation of pain. Methods:Following Ethics Committee approval and informed patients consent, Ninety patients 20-60 yr old ASA physical status I or II, scheduled for femur surgery under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The magnesium group (groupM) received bupivacaine 15mg combined with 0.5ml magnesium 10%,the fentanyl group (group F) received bupivacaine 15mg combined with0.5 ml fentanyl[25microgram] and the placebo group (group P) received bupivacaine 15mg combined with 0.5ml distilled water intrathecally . Time to first requirement of analgesic supplement, Sensory block onset time, maximum sensory level , onset of motor block, duration of blockade, hemodynamics variables, the incidence of hypotension, ephedrine requirements, bradycardia ,hypoxemia [Saturation of peripheral oxygen (SpO2)<90], postoperative analgesic requirements and Adverse events, such as sedation, dizziness , Pruritus and postoperative nausea and vomiting were recorded. Patients were instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient requested a supplement analgesic, methadon5 mg intravenously , was to be given for post-operative pain relief as needed .

Interventions

Ninety patients 20-60 yr old American Society of Anesthesiologists ( ASA) physical status I or II, scheduled for femur surgery under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The magnesium group (groupM) received bupivacaine 15mg combined with 0.5ml magnesium 10%,The fentanyl group (group F) received bupivacaine 15mg combined with0.5 ml fentanyl[25microgram] and The placebo group (gr

Ninety patients 20-60 yr old American Society of Anesthesiologists ( ASA) physical status I or II, scheduled for femur surgery under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The magnesium group (groupM) received bupivacaine 15mg combined with 0.5ml magnesium 10%,The fentanyl group (group F) received bupivacaine 15mg combined with0.5 ml fentanyl[25microgram] and The placebo group (group P) received bupivacaine 15mg combined with 0.5ml distilled water(intrathecally) for each three groups 5 minutes prior to surgery)

Sponsors

Qazvin Medical Science University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

patients with American Society of Anesthesiologists(ASA) physical status I and II, undergoing elective femur surgery

Exclusion criteria

significant coexisting disease such as hepato-renal and cardiovascular disease, any contraindication to regional anesthesia such as local infection or bleeding disorders, allergy to opioids, long-term opioid use or a history of chronic pain.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026