The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine

NCT01261078 | Completed

• 1 other identifier: SMC-2010-12-05
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Anesthesia

Keywords

intrathecal epinephrine; duration of anesthesia; quality of anesthesia; intrathecal fentanyl

Outcome Measures

Primary Outcomes (1)

• the sensory level of spinal anesthesia, the quality of intraoperative analgesia

  at 2, 5, 10, 20, and 30 min after the spinal injection and every 15 minutes thereafter until complete regression of spinal anesthesia.

  every 15 minutes

Study Arms (5)

Placebo

PLACEBO COMPARATOR

8 mg bupivacaine only

Drug: Placebo

Epi 25

ACTIVE COMPARATOR

8 mg of bupivacaine mixed with 25 mcg of epinephrine

Drug: epinephrine 25

Epi 50

ACTIVE COMPARATOR

8 mg of bupivacaine mixed with 50 mcg of epinephrine

Drug: Epinephrine 50

Epi 100

ACTIVE COMPARATOR

8 mg of bupivacaine mixed with 0.1 mg of epinephrine

Drug: epinephrine 100

Epi 200

ACTIVE COMPARATOR

intrathecal bupivacaine 8 mg with 200 mcg of epinephrine

Drug: Epi 200

Interventions

Placebo DRUG

intrathecal 8 mg of bupivacaine only

Also known as: Epinephrine

Placebo

epinephrine 25 DRUG

intrathecal 8 mg of bupivacaine mixed with 25 mcg of epinephrine

Also known as: Epinephrine

Epi 25

Epinephrine 50 DRUG

intrathecal 8 mg of bupivacaine mixed with 50 mcg of epinephrine

Also known as: Epinephrine

Epi 50

epinephrine 100 DRUG

intrathecal 8 mg of bupivacaine mixed with 0.1 mg of epinephrine

Also known as: Epinephrine

Epi 100

Epi 200 DRUG

intrathecal bupivacaine 8 mg with 200 mcg of epinephrine

Also known as: epinephrine

Epi 200

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient undergoing total knee replacement arthroplasty

You may not qualify if:

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

Sponsors & Collaborators

• Seoul Medical Center: lead

Study Sites (1)

Seoul Medical Center

Seoul, 135-740, South Korea

Location

MeSH Terms

Interventions

Epinephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Won Ho Kim, M.D.

  Seoul Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 16, 2010
• Study Start: December 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 20, 2011

Record last verified: 2010-12

Locations

KR (1)