The Analgesic Effect of Intrathecal Hydromorphone Injection on Spinal Anesthesia

This study has been completed.

Sponsor:

Collaborator:

Korea University

Information provided by:

Korea University Anam Hospital

ClinicalTrials.gov Identifier:

NCT01172782

First received: July 28, 2010

Last updated: June 23, 2011

Last verified: January 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	July 28, 2010
Last Updated Date	June 23, 2011
Start Date ^ICMJE	July 2009
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2011)	Visual Analgesic Numberic Score [ Time Frame: during postoperative recovery period. ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01172782 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Analgesic Effect of Intrathecal Hydromorphone Injection on Spinal Anesthesia
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Sixty patients who were undergoing unilateral knee arthroscopy randomly received unilateral spinal anesthesia with 0.5% hyperbaric bupivacaine 6 mg combined with normal saline 0.05 mL or hydromorphone 2.5, 5 or, 10 μg/0.05 mL. The verbal numerical rating scale (VNRS) pain scores were measured at 30 minutes and 2, 4, 6, 12 and 24 hours postoperatively, and the side effects of hydromorphone were recorded.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care
Condition ^ICMJE	Pain Measurement Visual Analog Pain Scale
Intervention ^ICMJE	Drug: Hydromorphone 2.5, 5, 10 ug of hydromorphone, intrathecal injection, single injection. duration of intrathecal injection are not fully studied.
Study Arm (s)	Placebo Comparator: control group control group (CG) received 6 mg of hyperbaric bupivacaine and 0.05 mL of saline. Intervention: Drug: Hydromorphone Active Comparator: 2.5 ug hydromorphone recieved group 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 Intervention: Drug: Hydromorphone Active Comparator: 5 μg hydromorphone group 5 μg hydromorphone group received 1.2 mL of 0.5% hyperbaric bupivacaine and 5 μg of hydromorphone in 0.05 mL of saline Intervention: Drug: Hydromorphone Active Comparator: the 10 μg hydromorpnone group 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. Intervention: Drug: Hydromorphone
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	July 2010
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: ASA class I-II (age range: 18-72 years) Informed consent obtained patients Exclusion Criteria: The exclusion criteria included evidence of neurological or neuromuscular disease, respiratory or cardiac disease, diabetes mellitus or peripheral neuropathy, as well as those patients who were receiving chronic analgesic therapy or who had infection at the intended site of spinal needle insertion or who had hypersensitivity to amide local anesthetics or opioids
Gender	Both
Ages	18 Years to 72 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01172782
Other Study ID Numbers ^ICMJE	minware2
Has Data Monitoring Committee	Yes
Responsible Party	Too Jae Min, anesthesiology department, clinical professor, Department of Anesthesiology and Pain Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Ansan, Korea
Study Sponsor ^ICMJE	Korea University Anam Hospital
Collaborators ^ICMJE	Korea University
Investigators ^ICMJE	Not Provided
Information Provided By	Korea University Anam Hospital
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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