NCT02581566

Brief Summary

Comparison between intrathecal Dexmedetomidine versus Intraarticular Dexmedetomidine on postoperative pain after knee arthroscopy.

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 postoperative-pain

Timeline
Completed

Started Jul 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

9 months

First QC Date

October 18, 2015

Last Update Submit

March 11, 2019

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • postoperative pain

    Assesment is done by Visual Analog Scale

    24 hours

Secondary Outcomes (1)

  • c-reactive protein

    24 hours

Study Arms (3)

Intrathecal Dexmedetomidine Group

ACTIVE COMPARATOR

30 patients will be given Intrathecal Dexmedetomidine plus Intrathecal Bupivacaine

Drug: Intrathecal Dexmedetomidine

Intraarticular Dexmedetomidine Group

ACTIVE COMPARATOR

30 patients will be given Intraarticular Dexmedetomidine plus Intrathecal Bupivacaine

Drug: Intraarticular Dexmedetomidine

control Group

OTHER

30 patients will be given Intrathecal Bupivacaine

Drug: Bupivacaine

Interventions

Intrathecal DexmedetomidineDRUG

Addition of Intathecal Dexmedetomidine plus Intrathecal Bupivacaine

Intrathecal Dexmedetomidine Group
Intraarticular DexmedetomidineDRUG

Addition of Intraarticular Dexmedetomidine plus Intrathecal Bupivacaine

Intraarticular Dexmedetomidine Group
BupivacaineDRUG

Intrathecal Bupivacaine

control Group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients, ASA I-II, undergoing knee arthroscopy under spinal anesthesia.

You may not qualify if:

  • Absolute or relative contraindications to spinal anesthesia, allergy to dexmedetomidine or chronic pain treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 18, 2015

First Posted

October 21, 2015

Study Start

July 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

March 13, 2019

Record last verified: 2019-03

Locations

EG(1)