Comparison of the effect of intrathecal fentanyl citrate and magnesium sulphate as adjuvants to hyperbaric levobupivacaine 0.5 per cent for spinal anaesthesia in patients undergoing lower limb orthopaedic surgeries A prospective randomised study
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- onset and duration of sensory and motor block, duration of analgesia
Study Overview
Brief Summary
:
This prospective randomised study tocompare the effects of fentanyl vs magnesium sulphate as adjuvants to 0.5% hyperbaric levobupivacaine in orthopaedic surgeries under subarachnoid block shallinclude ninety ASA grade I and II patients aged 18-60 yrs undergoing orthopaedic surgeries. Group LS: 3ml 0.5% levobupivacaine heavy + 0.5ml normal saline. Group LF: 3ml 0.5% levobupivacaine heavy + fentanyl 25µg. Group LM: 3ml 0.5% levobupivacaine heavy + magnesium sulphate 50mg + 0.4ml normal saline. The onset and duration of sensory and motor block and intraoperative haemodynamics will be recorded. In the postoperative period, duration of analgesia, time to first request of analgesia, VAS scores, and side effects will be observed and compared amonf all three groups.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients consenting to participate in the study, aged between 18-60 years, of both sexes, of ASA grade I or II, admitted to undergo lower limb orthopaedic procedures in our institute were included in this study.
Exclusion Criteria
- •Patients declining consent, aged less than 18 or greater than 60 years, ASA grades III or IV, suffering from any respiratory, cardiac, hepatic, renal, neurological or coagulation disorder, pregnant or already receiving opioid or magnesium therapy or having any local infection at the site of injection of spinal anaesthesia were excluded from the study.
Outcomes
Primary Outcomes
onset and duration of sensory and motor block, duration of analgesia
Time Frame: onset of sensory and motor blockade at baseline | duration of sensory blockade when the spinal block regresses till S1 (in minutes) | duration of motor block till time of first mobilisation (in minutes) | duration of analgesia until the patient requests rescue analgesia at VAS score greater than 3
Secondary Outcomes
- haemodynamic parameters(baseline, intraoperative intervals predefined at 5, 10, 15, 30, 45, 60, 90, 120 & 150 minutes)
- side effects(in the postoperative period)
Investigators
Anusha Tripathy
Gajra Raja Medical College