NCT02818985

Brief Summary

Pain relief in knee Arthroscopic Surgery is essential for rapid recovery of function.

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_2 postoperative-pain

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_2 postoperative-pain

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

June 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

8 months

First QC Date

June 28, 2016

Last Update Submit

June 23, 2017

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • pain free time

    VAS

    48 hours

Study Arms (3)

Dexamethasone

ACTIVE COMPARATOR

patients will receive intra-articular 8 mg dexamethasone added to 18 mL 0.25% bupivacaine into the knee joint.

Drug: Dexamethasone

Dexmedetomidine

ACTIVE COMPARATOR

patients will receive intra-articular 1ug/kg dexmedetomidine added to 18 mL 0.25% bupivacaine into the knee joint.

Drug: Dexmedetomidine

Control

PLACEBO COMPARATOR

patients will receive intra-articular 18 mL 0.25% bupivacaine and 2mL isotonic saline into the knee joint.

Drug: Saline

Interventions

DexamethasoneDRUG

patients will receive intra-articular 8 mg dexamethasone added to 18 mL 0.25% bupivacaine into the knee joint.

Dexamethasone
DexmedetomidineDRUG

patients will receive intra-articular 1ug/kg dexmedetomidine added to 18 mL 0.25% bupivacaine into the knee joint.

Dexmedetomidine
SalineDRUG

patients will receive intra-articular 18 mL 0.25% bupivacaine and 2mL isotonic saline into the knee joint.

Control

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for knee arthroscopy under spinal anaesthesia

You may not qualify if:

  • Diabetes Mellitus
  • Contraindication to spinal anesthesia
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seham Mohamed Moeen Ibrahim

Asyut, 71111, Egypt

Location

Related Publications (1)

  • Moeen SM, Ramadan IK, Elkady HA. Dexamethasone and Dexmedetomidine as an Adjuvant to Intraarticular Bupivacaine for Postoperative Pain Relief in Knee Arthroscopic Surgery: A Randomized Trial. Pain Physician. 2017 Nov;20(7):671-680.

    PMID: 29149146DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

DexamethasoneDexmedetomidineSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Seham M Moeen, MD

    Assiut Univerisity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
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
MD

Study Record Dates

First Submitted

June 28, 2016

First Posted

June 30, 2016

Study Start

June 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

June 27, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share

Locations

EG(1)