The Analgesic Effect of Intrathecal Hydromorphone Injection on Spinal Anesthesia

Pain Measurement Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01172782
• Other study ID #: minware2
• Status: Completed
• Phase: N/A
• First received: July 28, 2010
• Last updated: June 23, 2011
• Start date: July 2009
• Est. completion date: July 2010

Study information

• Verified date: January 2010
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review BoardKorea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 72 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Pain Measurement
• Visual Analog Pain Scale

Intervention

Drug:
• Hydromorphone
2.5, 5, 10 ug of hydromorphone, intrathecal injection, single injection. duration of intrathecal injection are not fully studied.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Anam Hospital	Korea University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analgesic Numberic Score		during postoperative recovery period.	Yes