- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02713685
Comparison of Combined Sciatic(Winnie's) Femoral Nerve Block, and Subarachnoid Block Anesthesia for Lower Limb Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
After taking approval from institutional ethics committee, 60 ASA grade - I, II, III patients will be enrolled in the study undergoing lower limb surgeries. Patients will be randomly allocated in 2 groups of 30 patients each - Group S (spinal group) and Group B (nerve block group). Informed consent shall be taken prior to procedure. Patients will also be told about VAS score for pain- 0= no pain and 10= worst imaginable pain.
In the operating room, after securing 18G IV cannula, all standard monitors will be attached (NIBP, SPO2, ECG, Temperature probe, foley's catheterization). Patients will be premedicated with inj. Ondansetron-4mg IV stat and inj. Midazolam- 1mg IV stat in both the groups before starting the procedure. Group S (SAB)- patients will be preloaded with 10mg/kg Ringer lactate. Subarachnoid block in L3-L4, L4-L5 space with 0.5% Bupivacaine (Hyperbaric)-2.5ml will be given in lateral position with involved limb in dependent position. Patient kept in same position for 15 minutes and then turned supine. Group B (peripheral nerve block)- femoral 3 in 1 block in supine position(with landmark technique) will be given with 20 ml of 0.25% of Bupivacaine followed by sciatic block in Labat's approach in lateral position with 20 ml of 0.25% Bupivacaine .
Sensory block will be evaluated using the pinprick test using 22-gauge hypodermic needle, and it will be judged adequate if there will be a complete loss of pinprick sensation at T12 in the spinal group, or in the femoral and sciatic nerve distribution in the sciatic-femoral group. Onset of Motor blockade will be taken when Bromage score 4 would have been achieved. Bromage score 1- free movement of legs and feet; 2- just able to flex knees; 3- unable to flex knees but free movement of feet; 4- unable to move legs or feet. VAS score would be assessed after the procedure and surgery. Patients' vitals will be recorded before procedure, just after the procedure and intraoperative at 5, 15 and 30 min of surgery. After completion of surgery, hemodynamic parameters would be recorded and patient would be asked about VAS score. After surgery, patient's and surgeon's satisfaction would also be evaluated as 'Yes' or 'No'. Duration of analgesia will be calculated from onset of sensory blockade to 1st requirement of analgesic (VAS score >5). Injection Diclofenac- 75mg iv infusion will be given for treatment of pain.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Uttarakhand
-
Haldwani, Uttarakhand, India, 263139
- Government Medical College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA grade 1/2 patients posted for unilateral lower limb orthopedic surgery
Exclusion Criteria:
- ASA grade 3/4, psychiatric patients, allergy to local anesthetics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Subarachnoid block
Subarachnoid block will be given in lateral position
|
Subarachnoid block will be given using 2.5 ml of 0.5%Bupivacaine for lower limb anesthesia
|
Active Comparator: Peripheral nerve block
Combined Femoral and Sciatic nerve block will be given using nerve stimulation technique
|
Femoral and Sciatic nerve blocks will be given using total 40 ml of 0.25%of Bupivacaine to anesthetise for lower limb surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
duration of analgesia
Time Frame: 24 hours
|
after surgery upto patient demands analgesia
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VAS score after surgery
Time Frame: 4 hours
|
subjective VAS score after completion of surgery
|
4 hours
|
onset of sensory block
Time Frame: 30 minutes
|
sensory block will be assessed by subjective pin prick test up to achieving loss of sensation in every dermatome involved in surgery
|
30 minutes
|
onset of motor block
Time Frame: 30 minutes
|
after giving block up to achievement of modified Bromage score of 4
|
30 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
duration of sensory block
Time Frame: 4 hrs
|
after block upto 2 segments regression from highest level of block
|
4 hrs
|
duration of motor block
Time Frame: 4 hrs
|
after block up to start of movement of the limb
|
4 hrs
|
surgeon satisfaction
Time Frame: 4 hrs
|
subjective yes/ no response
|
4 hrs
|
Patient satisfaction
Time Frame: 4 hrs
|
subjective yes/no response
|
4 hrs
|
Collaborators and Investigators
Investigators
- Principal Investigator: SUBHRO MITRA, MD, Assistant Professor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 294/GMC/IEC/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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