NCT01245868

Brief Summary

The purpose of the study is to investigate if a small amount of lignocaine added to bupivacaine for spinal anesthesia to patients planned for arthroscopic knee surgery, can shorten the duration of the sensoric and the motoric blockade.

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 phase_4

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

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

November 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2010

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 23, 2010

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 8, 2015

Status Verified

May 1, 2015

Enrollment Period

1.1 years

First QC Date

June 14, 2010

Last Update Submit

May 7, 2015

Conditions

Spinal Anesthesia

Keywords

Spinal anaesthesiaBupivacaineLidocaineDuration of blockade

Outcome Measures

Primary Outcomes (1)

  • Duration of spinal blockade

    Repeating monitoring every 15 minutes after applying the blockade, up to 360 minutes.

Secondary Outcomes (1)

  • Time to fulfillment of discharge criteria from the hospital.

    Evaluated every 15 minutes after the operation up to 360 minutes. On average 200 to 300 minutes.

Study Arms (2)

Bupivacaine

EXPERIMENTAL

Bupivacaine as used routinely

Drug: bupivacaine

Lidocaine added to bupivacaine

PLACEBO COMPARATOR

lidocaine is added to bupivacaine

Drug: LidocaineDrug: bupivacaine

Interventions

LidocaineDRUG
Lidocaine added to bupivacaine
bupivacaineDRUG
BupivacaineLidocaine added to bupivacaine

Eligibility Criteria

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

You may qualify if:

  • The patient want spinal anaesthesia
  • No contradictions against spinal anaesthesia
  • Healthy people (ASA-score 1 or 2)
  • Body mass index \< 35 and between 155 and 190 cm

You may not qualify if:

  • Known allergic reactions to planned drugs
  • Neurologic disturbances
  • Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dep. of anesthesiology, Hospital of Frederikssund

Frederikssund, 3600, Denmark

Location

Jon Jacobsen

Frederikssund, DK 3600, Denmark

Location

MeSH Terms

Interventions

LidocaineBupivacaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Jon Jacobsen, M.D.

    Frederikssunds Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief consultant

Study Record Dates

First Submitted

June 14, 2010

First Posted

November 23, 2010

Study Start

November 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

May 8, 2015

Record last verified: 2015-05

Locations

DK(2)