NCT01172782

Brief Summary

The purpose of this study is to evaluate the adequate dose of intrathecal hydromorphone injection for postoperative pain relief after knee arthroscopic surgery.

Trial Health

100
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 Jul 2009

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, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2010

Completed
Last Updated

June 27, 2011

Status Verified

January 1, 2010

Enrollment Period

7 months

First QC Date

July 28, 2010

Last Update Submit

June 23, 2011

Conditions

Pain MeasurementVisual Analog Pain Scale

Outcome Measures

Primary Outcomes (1)

  • Visual Analgesic Numberic Score

    during postoperative recovery period.

Study Arms (4)

control group

PLACEBO COMPARATOR

control group (CG) received 6 mg of hyperbaric bupivacaine and 0.05 mL of saline.

Drug: Hydromorphone

2.5 ug hydromorphone recieved group

ACTIVE COMPARATOR

the 2.5 μg hydromorphone group (2.5HG) received 1.2 (6 mg) mL of 0.5% hyperbaric bupivacaine and 2.5 μg of hydromorphone in 0.05 mL of saline

Drug: Hydromorphone

5 μg hydromorphone group

ACTIVE COMPARATOR

5 μg hydromorphone group received 1.2 mL of 0.5% hyperbaric bupivacaine and 5 μg of hydromorphone in 0.05 mL of saline

Drug: Hydromorphone

the 10 μg hydromorpnone group

ACTIVE COMPARATOR

the 10 μg hydromorphone group received 1.2 mL of 0.5% hyperbaric bupivacaine and 10 μg of hydromorphone in 0.05 mL of saline.

Drug: Hydromorphone

Interventions

HydromorphoneDRUG

2.5, 5, 10 ug of hydromorphone, intrathecal injection, single injection. duration of intrathecal injection are not fully studied.

2.5 ug hydromorphone recieved group5 μg hydromorphone groupcontrol groupthe 10 μg hydromorpnone group

Eligibility Criteria

Age18 Years - 72 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA class I-II (age range: 18-72 years)
  • Informed consent obtained patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lee YS, Park YC, Kim JH, Kim WY, Yoon SZ, Moon MG, Min TJ. Intrathecal hydromorphone added to hyperbaric bupivacaine for postoperative pain relief after knee arthroscopic surgery: a prospective, randomised, controlled trial. Eur J Anaesthesiol. 2012 Jan;29(1):17-21. doi: 10.1097/EJA.0b013e3283476055.

    PMID: 21562420DERIVED

MeSH Terms

Interventions

Hydromorphone

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 28, 2010

First Posted

July 30, 2010

Study Start

July 1, 2009

Primary Completion

February 1, 2010

Study Completion

July 1, 2010

Last Updated

June 27, 2011

Record last verified: 2010-01