Post Operative Pain
Conditions
Keywords
magnesium, fentanyl, intrathecal, pain
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 .
Interventions
DRUGFentanyl
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)
DRUGplacebo(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)
DRUGmagnesium 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)
Sponsors
Qazvin University Of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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 * history of chronic pain.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| hemodynamic variables is assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring | 5min before the intrathecal injection | — |
| 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 |
| 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 |
Countries
Iran
Outcome results
None listed