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Comparison of Combined Sciatic(Winnie's) Femoral Nerve Block, and Subarachnoid Block Anesthesia for Lower Limb Surgery

G

Government Medical College, Haldwani

Status

Completed

Conditions

Anesthesia Local

Treatments

Procedure: combined Femoral and Sciatic nerve block
Procedure: Subarachnoid block

Study type

Interventional

Funder types

Other

Identifiers

NCT02713685
294/GMC/IEC/2016

Details and patient eligibility

About

60 ASA grades- I, II or III patients, undergoing lower limb surgeries, will be randomly allocated in 2 groups of 30 patients each. In group S- subarachnoid block with 0.5% Bupivacaine (hyperbaric) 2.5ml will be given in lateral position and group B received femoral 3 in 1 block in supine position(with landmark technique) with 20 ml of 0.25% of Bupivacaine, followed by Sciatic block in lateral position with 20 ml of 0.25% Bupivacaine. Onset and duration of sensory and motor block, time of first analgesic requirement, VAS Scores at end of block and surgery, hemodynamic effects, patients' and surgeon's satisfaction will be evaluated.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Subarachnoid block
Experimental group
Description:
Subarachnoid block will be given in lateral position
Treatment:
Procedure: Subarachnoid block
Peripheral nerve block
Active Comparator group
Description:
Combined Femoral and Sciatic nerve block will be given using nerve stimulation technique
Treatment:
Procedure: combined Femoral and Sciatic nerve block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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