Comparison of Postoperative Analgesic Effect of Intrathecal Magnesium and Fentanyl Added to Bupivacaine in Patients Undergoing Lower Limb Orthopedic Surgery

Phase 1

Completed

• Conditions: Post Operative Pain
• Interventions: Drug: placebo(distilled water); Drug: Fentanyl; Drug: magnesium sulphate

• Registration Number: NCT01205997
• Lead Sponsor: Qazvin University Of Medical Sciences

Brief Summary

Magnesium has been suggested that NMDA (N-methyl D-aspartate)receptor antagonists induce preemptive analgesia when administrated before tissue injury , thus decreasing the subsequent sensation of pain.

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-09-20
• Study First Submitted QC: 2010-09-20
• Study First Posted: 2010-09-21
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-10
• Last Update Posted: 2012-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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
• history of chronic pain.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo(distilled water)	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)
fentanyl	Fentanyl	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)
magnesium sulphate	magnesium sulphate	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)

Primary Outcome Measures

Name	Time	Method
Time to first requirement of analgesic supplement	time to first requirement of analgesic supplement from the time of injection intrathecal anesthetic solution	analgesic administration was initiated by patient request(verbal rating scale\[ VRS\]\>4)
postoperative analgesic requirements	12 hours postoperative	postoperative analgesic requirements will be assessed by verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain).Each administration was initiated by patient request( VRS\>4)

Secondary Outcome Measures

Name	Time	Method
Sensory block onset time will be assessed by a pinprick test	sensory block will be assessed by pinprick test every 10 seconds following intrathecal injection	The onset of sensory block was defined as the time between the end of injection of the intrathecal anesthetic and the absence of pain at the T10 dermatome
duration of sensory block will be assessed by a pinprick test	sensory block will be assessed by pinprick test every 5 minuts following intrathecal injection	The duration of sensory block was defined as the time between the end of injection of the intrathecal anestheticthe time and regression of two segments from the maximum block height
the onset of motor block will be assessed by the modified Bromage score	every10 seconds following intrathecal injection	The onset of motor block was defined as the time between the end of injection of the intrathecal anesthetic to Bromage block 1
duration of motor block will be assessed by the modified Bromage score	every 5 minuts following intrathecal injection	duration of motor block was defined the time from intrathecal injection to Bromage score0
hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring	20minutes after intrathecal injection

Trial Locations

Locations (1)

Qazvin university of medical science; 🇮🇷 Qazvin, Iran, Islamic Republic of