NCT02513433

Brief Summary

This study compares the clinical efficacy of newer local anaesthetic drugs Levobupivacaine and Ropivacaine with Bupivacaine in lumbar epidural anaesthesia for hip surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2015

Completed
Last Updated

August 4, 2015

Status Verified

July 1, 2015

Enrollment Period

1.7 years

First QC Date

July 30, 2015

Last Update Submit

July 31, 2015

Conditions

Pain Insensitivity, Congenital

Keywords

Lumbar epidural anaesthesia

Outcome Measures

Primary Outcomes (1)

  • Onset of sensory block

    Time to achieve sensory block up to tenth thoracic dermatome

    30 minutes

Secondary Outcomes (2)

  • Time for 2 segment regression of sensory block

    90 minutes

  • Time to achieve maximum motor block

    45 minutes

Study Arms (3)

Bupivacaine & Levobupivacaine

ACTIVE COMPARATOR

Bupivacaine 15 ml 0.5% and Levobupivacaine 15 ml 0.5% in epidural route before surgery

Drug: BupivacaineDrug: Levobupivacaine

Bupivacaine & Ropivacaine

ACTIVE COMPARATOR

Bupivacaine 15 ml 0.5% and Ropivacaine 15 ml 0.75% in epidural route before surgery

Drug: BupivacaineDrug: Ropivacaine

Ropivacaine & Levobupivacaine

ACTIVE COMPARATOR

Ropivacaine 15 ml 0.75% and Levobupivacaine 15 ml 0.5% in epidural route before surgery

Drug: LevobupivacaineDrug: Ropivacaine

Interventions

BupivacaineDRUG

Local anesthetic

Also known as: Anawin, Sensorcaine
Bupivacaine & LevobupivacaineBupivacaine & Ropivacaine
LevobupivacaineDRUG

Local anesthetic

Also known as: Levo-anawin
Bupivacaine & LevobupivacaineRopivacaine & Levobupivacaine
RopivacaineDRUG

Local anesthetic

Also known as: Ropin
Bupivacaine & RopivacaineRopivacaine & Levobupivacaine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA Grade I and II patients of either sex
  • Age 18-60 years
  • Undergoing various hip surgeries under lumbar epidural anesthesia

You may not qualify if:

  • Refusal for epidural
  • ASA-III\&IV
  • Head injury
  • Psychiatric disease
  • Known allergic to test drugs
  • Major systemic disease
  • Any analgesia with in past 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Government Medical College

Haldwani, Uttarakhand, 263139, India

Location

MeSH Terms

Conditions

Pain Insensitivity, Congenital

Interventions

BupivacaineLevobupivacaineRopivacaine

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Geeta Bhandari, M.D.

    Professor and Head of the department

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 30, 2015

First Posted

July 31, 2015

Study Start

December 1, 2012

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

August 4, 2015

Record last verified: 2015-07

Locations

IN(1)