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

Post Operative Pain Clinical Trial

Official title:

The Effects of Intrathecal Magnesium and Fentanyl Added to Bupivacaine on Postoperative Analgesic Requirement in Patients Undergoing Lower Limb Orthopedic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01205997
• Other study ID #: ACTRN12610000757011
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 20, 2010
• Last updated: October 10, 2012
• Start date: August 2010
• Est. completion date: January 2011

Study information

• Verified date: October 2012
• Source: Qazvin University Of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• 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)
• 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)
• 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)

Locations

Country	Name	City	State
Iran, Islamic Republic of	Qazvin university of medical science	Qazvin

Sponsors (1)

Lead Sponsor	Collaborator
Qazvin University Of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first requirement of analgesic supplement	analgesic administration was initiated by patient request(verbal rating scale[ VRS]>4)	time to first requirement of analgesic supplement from the time of injection intrathecal anesthetic solution	Yes
Primary	postoperative analgesic requirements	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)	12 hours postoperative	Yes
Secondary	Sensory block onset time will be assessed by a pinprick test	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	sensory block will be assessed by pinprick test every 10 seconds following intrathecal injection	Yes
Secondary	duration of sensory block will be assessed by a pinprick test	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	sensory block will be assessed by pinprick test every 5 minuts following intrathecal injection	Yes
Secondary	the onset of motor block will be assessed by the modified Bromage score	The onset of motor block was defined as the time between the end of injection of the intrathecal anesthetic to Bromage block 1	every10 seconds following intrathecal injection	Yes
Secondary	duration of motor block will be assessed by the modified Bromage score	duration of motor block was defined the time from intrathecal injection to Bromage score0	every 5 minuts following intrathecal injection	Yes
Secondary	hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring		5min before the intrathecal injection	Yes
Secondary	hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring		2minutes after intrathecal injection	Yes
Secondary	hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring		4minutes after intrathecal injection	Yes
Secondary	hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring		6minutes after intrathecal injection	Yes
Secondary	hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring		8minutes after intrathecal injection	Yes
Secondary	hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring		10minutes after intrathecal injection	Yes
Secondary	hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring		15minutes after intrathecal injection	Yes
Secondary	hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring		20minutes after intrathecal injection	Yes