The Analgesic Effect of Intrathecal Hydromorphone Injection on Spinal Anesthesia

Study Overview
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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

Intervention / Treatment
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* Drug: Hydromorphone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>control group (CG) received 6 mg of hyperbaric bupivacaine and 0.05 mL of saline. | Drug: Hydromorphone<br>* 2.5, 5, 10 ug of hydromorphone, intrathecal injection, single injection. duration of intrathecal injection are not fully studied.<br>|
| Active Comparator: 2.5 ug hydromorphone recieved group<br>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<br>* 2.5, 5, 10 ug of hydromorphone, intrathecal injection, single injection. duration of intrathecal injection are not fully studied.<br>|
| Active Comparator: 5 μg hydromorphone group<br>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<br>* 2.5, 5, 10 ug of hydromorphone, intrathecal injection, single injection. duration of intrathecal injection are not fully studied.<br>|
| Active Comparator: the 10 μg hydromorpnone group<br>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<br>* 2.5, 5, 10 ug of hydromorphone, intrathecal injection, single injection. duration of intrathecal injection are not fully studied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analgesic Numberic Score |  | during postoperative recovery period. |