The Analgesic Effect of Intrathecal Hydromorphone Injection on Spinal Anesthesia

Korea University

Status: Completed

Conditions: Visual Analog Pain Scale; Pain Measurement

Treatments: Drug: Hydromorphone

Study type: Interventional

Funder types: Other

Identifiers

NCT01172782

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Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 72 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Hydromorphone

2.5 ug hydromorphone recieved group

Active Comparator group

Description:

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

Treatment:

Drug: Hydromorphone

5 μg hydromorphone group

Active Comparator group

Description:

5 μg hydromorphone group received 1.2 mL of 0.5% hyperbaric bupivacaine and 5 μg of hydromorphone in 0.05 mL of saline

Treatment:

Drug: Hydromorphone

the 10 μg hydromorpnone group

Active Comparator group

Description:

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.

Treatment:

Drug: Hydromorphone