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Clinical Trials/NCT01172782
NCT01172782
Completed
Not Applicable

The Analgesic Effect of Intrathecal Hydromorphone Injection on Spinal Anesthesia

Korea University Anam Hospital0 sites60 target enrollmentJuly 2009

Overview

Phase
Not Applicable
Intervention
Hydromorphone
Conditions
Pain Measurement
Sponsor
Korea University Anam Hospital
Enrollment
60
Primary Endpoint
Visual Analgesic Numberic Score
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2009
End Date
July 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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

Arms & Interventions

control group

control group (CG) received 6 mg of hyperbaric bupivacaine and 0.05 mL of saline.

Intervention: Hydromorphone

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: Hydromorphone

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: Hydromorphone

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: Hydromorphone

Outcomes

Primary Outcomes

Visual Analgesic Numberic Score

Time Frame: during postoperative recovery period.

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