The Analgesic Effect of Intrathecal Hydromorphone Injection on Spinal Anesthesia

• Sponsor: Korea University Anam Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01172782
• Collaborator: Korea University (Other)
• Enrollment: 60
• Arms: 4
• Duration (Months): 12

Study Details

Study Description

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	Phase
Pain Measurement; Visual Analog Pain Scale	Drug: Hydromorphone	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Visual Analgesic Numberic Score [during postoperative recovery period.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 72 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

No locations specified.

Sponsors and Collaborators

• Korea University Anam Hospital
• Korea University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01172782
• Other Study ID Numbers: minware2
• First Posted: Jul 30, 2010
• Last Update Posted: Jun 27, 2011
• Last Verified: Jan 1, 2010

• Additional relevant MeSH terms: Hydromorphone

Study Results

No Results Posted as of Jun 27, 2011