The Analgesic Effect of Intrathecal Hydromorphone Injection on Spinal Anesthesia

NCT ID: NCT01172782

Last Updated: 2011-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-07-31

Brief Summary

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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

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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.

Conditions

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Pain Measurement Visual Analog Pain Scale

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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control group

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

Group Type PLACEBO_COMPARATOR

Hydromorphone

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Hydromorphone

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Hydromorphone

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Hydromorphone

Intervention Type DRUG

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

Interventions

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Hydromorphone

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA class I-II (age range: 18-72 years)
* Informed consent obtained patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Korea University

OTHER

Sponsor Role collaborator

Korea University Anam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Anesthesiology and Pain Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Ansan, Korea

References

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Lee YS, Park YC, Kim JH, Kim WY, Yoon SZ, Moon MG, Min TJ. Intrathecal hydromorphone added to hyperbaric bupivacaine for postoperative pain relief after knee arthroscopic surgery: a prospective, randomised, controlled trial. Eur J Anaesthesiol. 2012 Jan;29(1):17-21. doi: 10.1097/EJA.0b013e3283476055.

Reference Type DERIVED
PMID: 21562420 (View on PubMed)

Other Identifiers

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minware2

Identifier Type: -

Identifier Source: org_study_id

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