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

Sponsor
Government Medical College, Haldwani (Other)
Overall Status
Completed
CT.gov ID
NCT02713685
Collaborator
(none)
60
1
2
13
4.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Subarachnoid block
  • Procedure: combined Femoral and Sciatic nerve block
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Comparison of Combined Sciatic(Winnie's) Femoral Nerve Block, and Subarachnoid Block Anesthesia for Lower Limb Surgery
Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Jul 1, 2016
Actual Study Completion Date :
Jul 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Subarachnoid block

Subarachnoid block will be given in lateral position

Procedure: Subarachnoid block
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

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

Outcome Measures

Primary Outcome Measures

  1. duration of analgesia [24 hours]

    after surgery upto patient demands analgesia

Secondary Outcome Measures

  1. VAS score after surgery [4 hours]

    subjective VAS score after completion of surgery

  2. onset of sensory block [30 minutes]

    sensory block will be assessed by subjective pin prick test up to achieving loss of sensation in every dermatome involved in surgery

  3. onset of motor block [30 minutes]

    after giving block up to achievement of modified Bromage score of 4

Other Outcome Measures

  1. duration of sensory block [4 hrs]

    after block upto 2 segments regression from highest level of block

  2. duration of motor block [4 hrs]

    after block up to start of movement of the limb

  3. surgeon satisfaction [4 hrs]

    subjective yes/ no response

  4. Patient satisfaction [4 hrs]

    subjective yes/no response

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Government Medical College Haldwani Uttarakhand India 263139

Sponsors and Collaborators

  • Government Medical College, Haldwani

Investigators

  • Principal Investigator: SUBHRO MITRA, MD, Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Subhro Mitra, Assistant Professor, Government Medical College, Haldwani
ClinicalTrials.gov Identifier:
NCT02713685
Other Study ID Numbers:
  • 294/GMC/IEC/2016
First Posted:
Mar 21, 2016
Last Update Posted:
Aug 12, 2016
Last Verified:
Aug 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Dr Subhro Mitra, Assistant Professor, Government Medical College, Haldwani

Study Results

No Results Posted as of Aug 12, 2016