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The Analgesic Effect of Intrathecal Hydromorphone Injection on Spinal Anesthesia

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ClinicalTrials.gov Identifier: NCT01172782
Recruitment Status : Completed
First Posted : July 30, 2010
Last Update Posted : June 27, 2011
Sponsor:
Collaborator:
Korea University
Information provided by:
Korea University Anam Hospital

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.

Condition or disease Intervention/treatment
Pain Measurement Visual Analog Pain Scale Drug: Hydromorphone

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 : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Study Start Date : July 2009
Primary Completion Date : February 2010
Study Completion Date : July 2010

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U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: control group
control group (CG) received 6 mg of hyperbaric bupivacaine and 0.05 mL of saline.
Drug: Hydromorphone
2.5, 5, 10 ug of hydromorphone, intrathecal injection, single injection. duration of intrathecal injection are not fully studied.
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
Drug: Hydromorphone
2.5, 5, 10 ug of hydromorphone, intrathecal injection, single injection. duration of intrathecal injection are not fully studied.
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
Drug: Hydromorphone
2.5, 5, 10 ug of hydromorphone, intrathecal injection, single injection. duration of intrathecal injection are not fully studied.
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.
Drug: Hydromorphone
2.5, 5, 10 ug of hydromorphone, intrathecal injection, single injection. duration of intrathecal injection are not fully studied.



Primary Outcome Measures :
  1. Visual Analgesic Numberic Score [ Time Frame: during postoperative recovery period. ]


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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
ClinicalTrials.gov Identifier: NCT01172782     History of Changes
Other Study ID Numbers: minware2
First Posted: July 30, 2010    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: January 2010

Additional relevant MeSH terms:
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents