The Analgesic Effect of Intrathecal Hydromorphone Injection on Spinal Anesthesia

Not Applicable

Completed

• Conditions: Visual Analog Pain Scale; Pain Measurement
• Interventions: Drug: Hydromorphone

• Registration Number: NCT01172782
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-07
• Status Verified: 2010-01
• Primary Completion: 2010-02
• Study Completion: 2010-07
• Study First Submitted: 2010-07-28
• Study First Submitted QC: 2010-07-29
• Study First Posted: 2010-07-30
• Last Update Submitted: 2011-06-23
• Last Update Posted: 2011-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Hydromorphone	control group (CG) received 6 mg of hyperbaric bupivacaine and 0.05 mL of saline.
2.5 ug hydromorphone recieved group	Hydromorphone	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
the 10 μg hydromorpnone group	Hydromorphone	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.
5 μg hydromorphone group	Hydromorphone	5 μg hydromorphone group received 1.2 mL of 0.5% hyperbaric bupivacaine and 5 μg of hydromorphone in 0.05 mL of saline

Primary Outcome Measures

Name	Time	Method
Visual Analgesic Numberic Score	during postoperative recovery period.