The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine

Not Applicable

Completed

• Conditions: Spinal Anesthesia
• Interventions: Drug: Placebo; Drug: epinephrine 25; Drug: Epinephrine 50; Drug: epinephrine 100; Drug: Epi 200

• Registration Number: NCT01261078
• Lead Sponsor: Seoul Medical Center

Brief Summary

Intrathecal epinephrine has been known to increase the duration of spinal anesthesia, or increase the quality of anesthesia. However, there is still a controversy, and the mechanism of epinephrine is recently suggested as a modulator of pain information in the spinal cord. Therefore, the investigators try to investigate the dose sparing effect of intrathecal epinephrine for spinal anesthesia with bupivacaine.

Detailed Description

For patient undergoing total knee replacement arthroplasty, patients injected intrathecally with bupivacaine 8 mg were compared with those with bupivacaine 8 mg with 25 mcg of epinephrine, bupivacaine 8 mg with 50 mcg of epinephrine, and those with bupivacaine 8 mg with 100 mcg of epinephrine. The investigators compared the characteristics of spinal anesthesia including the quality and complication of spinal anesthesia. The researchers investigated whether intrathecal dose of epinephrine can reduce bupivacaine requirement and this effect is dependent on the dose of epinephrine.

Study Timeline

• Status Verified: 2010-12
• Study Start: 2010-12
• Study First Submitted: 2010-12-15
• Study First Submitted QC: 2010-12-15
• Study First Posted: 2010-12-16
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Last Update Submitted: 2011-07-19
• Last Update Posted: 2011-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• patient undergoing total knee replacement arthroplasty

Exclusion Criteria

• patient with cardiac or pulmonary disease (ASA class III or more)
• patient undergone previous spine surgery
• patient undergoing revised knee replacement

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	8 mg bupivacaine only
Epi 25	epinephrine 25	8 mg of bupivacaine mixed with 25 mcg of epinephrine
Epi 50	Epinephrine 50	8 mg of bupivacaine mixed with 50 mcg of epinephrine
Epi 100	epinephrine 100	8 mg of bupivacaine mixed with 0.1 mg of epinephrine
Epi 200	Epi 200	intrathecal bupivacaine 8 mg with 200 mcg of epinephrine

Primary Outcome Measures

Name	Time	Method
the sensory level of spinal anesthesia, the quality of intraoperative analgesia	every 15 minutes	at 2, 5, 10, 20, and 30 min after the spinal injection and every 15 minutes thereafter until complete regression of spinal anesthesia.

Trial Locations

Locations (1)

Seoul Medical Center; 🇰🇷 Seoul, Korea, Republic of