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

NCT ID: NCT02713685

Last Updated: 2016-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-07-31

Brief Summary

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.

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.

Conditions

Anesthesia Local

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Subarachnoid block

Subarachnoid block will be given in lateral position

Group Type: EXPERIMENTAL

Subarachnoid block

Intervention Type: PROCEDURE

Subarachnoid block will be given using 2.5 ml of 0.5%Bupivacaine for lower limb anesthesia

Peripheral nerve block

Combined Femoral and Sciatic nerve block will be given using nerve stimulation technique

Group Type: ACTIVE_COMPARATOR

combined Femoral and Sciatic nerve block

Intervention Type: PROCEDURE

Femoral and Sciatic nerve blocks will be given using total 40 ml of 0.25%of Bupivacaine to anesthetise for lower limb surgery

Interventions

Subarachnoid block

Subarachnoid block will be given using 2.5 ml of 0.5%Bupivacaine for lower limb anesthesia

Intervention Type: PROCEDURE

combined Femoral and Sciatic nerve block

Femoral and Sciatic nerve blocks will be given using total 40 ml of 0.25%of Bupivacaine to anesthetise for lower limb surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Government Medical College, Haldwani

OTHER

Sponsor Role: lead

Responsible Party

Dr Subhro Mitra

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SUBHRO MITRA, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Government Medical College

Haldwani, Uttarakhand, India

Countries

India

Other Identifiers

294/GMC/IEC/2016

Identifier Type: -

Identifier Source: org_study_id