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

Anesthesia Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02713685
• Other study ID #: 294/GMC/IEC/2016
• Status: Completed
• Phase: N/A
• First received: March 11, 2016
• Last updated: August 11, 2016
• Start date: June 2015
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Government Medical College, Haldwani
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anesthesia Local

Intervention

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

Locations

Country	Name	City	State
India	Government Medical College	Haldwani	Uttarakhand

Sponsors (1)

Lead Sponsor	Collaborator
Government Medical College, Haldwani

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	duration of sensory block	after block upto 2 segments regression from highest level of block	4 hrs	No
Other	duration of motor block	after block up to start of movement of the limb	4 hrs	No
Other	surgeon satisfaction	subjective yes/ no response	4 hrs	No
Other	Patient satisfaction	subjective yes/no response	4 hrs	No
Primary	duration of analgesia	after surgery upto patient demands analgesia	24 hours	No
Secondary	VAS score after surgery	subjective VAS score after completion of surgery	4 hours	No
Secondary	onset of sensory block	sensory block will be assessed by subjective pin prick test up to achieving loss of sensation in every dermatome involved in surgery	30 minutes	No
Secondary	onset of motor block	after giving block up to achievement of modified Bromage score of 4	30 minutes	No