NCT02713685

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 12, 2016

Status Verified

August 1, 2016

Enrollment Period

1.1 years

First QC Date

March 11, 2016

Last Update Submit

August 11, 2016

Conditions

Anesthesia Local

Keywords

regional anesthesialower limb surgeryBupivacaine

Outcome Measures

Primary Outcomes (1)

  • duration of analgesia

    after surgery upto patient demands analgesia

    24 hours

Secondary Outcomes (3)

  • VAS score after surgery

    4 hours

  • onset of sensory block

    30 minutes

  • onset of motor block

    30 minutes

Other Outcomes (4)

  • duration of sensory block

    4 hrs

  • duration of motor block

    4 hrs

  • surgeon satisfaction

    4 hrs

  • +1 more other outcomes

Study Arms (2)

Subarachnoid block

EXPERIMENTAL

Subarachnoid block will be given in lateral position

Procedure: Subarachnoid block

Peripheral nerve block

ACTIVE COMPARATOR

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

Procedure: combined Femoral and Sciatic nerve block

Interventions

Subarachnoid blockPROCEDURE

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

Subarachnoid block
combined Femoral and Sciatic nerve blockPROCEDURE

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

Peripheral nerve block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA grade 1/2 patients posted for unilateral lower limb orthopedic surgery

You may not qualify if:

  • ASA grade 3/4, psychiatric patients, allergy to local anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Government Medical College

Haldwani, Uttarakhand, 263139, India

Location

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • SUBHRO MITRA, MD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 11, 2016

First Posted

March 21, 2016

Study Start

June 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 12, 2016

Record last verified: 2016-08

Locations

IN(1)