Text Size

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
  Purpose

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


Condition Intervention
Pain Measurement
Visual Analog Pain Scale
 Drug: Hydromorphone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Korea University Anam Hospital:

Primary Outcome Measures:
  • Visual Analgesic Numberic Score [ Time Frame: during postoperative recovery period. ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: July 2009
Study Completion Date: July 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Korea University Anam Hospital

Additional 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
Study First Received: July 28, 2010
Last Updated: June 23, 2011
Health Authority: Korea: Institutional Review Board
Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013