Spinal AnesthesiaNCT01261078
The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine
A study testing epinephrine 25, Epinephrine 50 and epinephrine 100 in people with Spinal Anesthesia, run by Seoul Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Spinal Anesthesia
- What is being tested?
- epinephrine 25, Epinephrine 50 and epinephrine 100
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2010to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient undergoing total knee replacement arthroplasty
Who cannot join
- patient with cardiac or pulmonary disease (ASA class III or more)
- patient undergone previous spine surgery
- patient undergoing revised knee replacement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine for Spinal Anesthesia in Total Knee Replacement Arthroplasty
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.
Read the 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.
- Conditions
- Spinal Anesthesia
- Being tested
- Placebo, epinephrine 25, Epinephrine 50, epinephrine 100, Epi 200
- Keywords
- intrathecal epinephrine, duration of anesthesia, quality of anesthesia, intrathecal fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Epinephrine
intrathecal 8 mg of bupivacaine only
epinephrine 25Drug
Also called Epinephrine
intrathecal 8 mg of bupivacaine mixed with 25 mcg of epinephrine
Epinephrine 50Drug
Also called Epinephrine
intrathecal 8 mg of bupivacaine mixed with 50 mcg of epinephrine
epinephrine 100Drug
Also called Epinephrine
intrathecal 8 mg of bupivacaine mixed with 0.1 mg of epinephrine
Epi 200Drug
Also called epinephrine
intrathecal bupivacaine 8 mg with 200 mcg of epinephrine
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 8 mg bupivacaine only Receives: Drug: Placebo |
| Epi 25 | Active comparator | 8 mg of bupivacaine mixed with 25 mcg of epinephrine Receives: Drug: epinephrine 25 |
| Epi 50 | Active comparator | 8 mg of bupivacaine mixed with 50 mcg of epinephrine Receives: Drug: Epinephrine 50 |
| Epi 100 | Active comparator | 8 mg of bupivacaine mixed with 0.1 mg of epinephrine Receives: Drug: epinephrine 100 |
| Epi 200 | Active comparator | intrathecal bupivacaine 8 mg with 200 mcg of epinephrine Receives: Drug: Epi 200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: every 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Won Ho Kim, M.D., Principal investigator, Seoul Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261078
- Sponsor's protocol ID
- SMC-2010-12-05
- Status last verified
- Dec 2010
- First submitted
- 15 Dec 2010
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine for Spinal Anesthesia in Total Knee Replacement Arthroplasty
- ClinicalTrials.gov ID
- NCT01261078
- Acronym / sponsor ID
- SMC-2010-12-05
- Conditions
- Spinal Anesthesia
- Keywords
- intrathecal epinephrine, duration of anesthesia, quality of anesthesia, intrathecal fentanyl
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Seoul Medical CenterUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 16 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo8 mg bupivacaine only |
| Epi 25 | Active comparator | Drug: epinephrine 258 mg of bupivacaine mixed with 25 mcg of epinephrine |
| Epi 50 | Active comparator | Drug: Epinephrine 508 mg of bupivacaine mixed with 50 mcg of epinephrine |
| Epi 100 | Active comparator | Drug: epinephrine 1008 mg of bupivacaine mixed with 0.1 mg of epinephrine |
| Epi 200 | Active comparator | Drug: Epi 200intrathecal bupivacaine 8 mg with 200 mcg of epinephrine |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient undergoing total knee replacement arthroplasty
Key exclusion criteria (3 listed)
- patient with cardiac or pulmonary disease (ASA class III or more)
- patient undergone previous spine surgery
- patient undergoing revised knee replacement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Epinephrineintrathecal 8 mg of bupivacaine only | Drug | Placebo |
| epinephrine 25Also: Epinephrineintrathecal 8 mg of bupivacaine mixed with 25 mcg of epinephrine | Drug | Epi 25 |
| Epinephrine 50Also: Epinephrineintrathecal 8 mg of bupivacaine mixed with 50 mcg of epinephrine | Drug | Epi 50 |
| epinephrine 100Also: Epinephrineintrathecal 8 mg of bupivacaine mixed with 0.1 mg of epinephrine | Drug | Epi 100 |
| Epi 200Also: epinephrineintrathecal bupivacaine 8 mg with 200 mcg of epinephrine | Drug | Epi 200 |
Primary outcome
the sensory level of spinal anesthesia, the quality of intraoperative analgesia
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Won Ho Kim, M.D. principal investigator
Seoul Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing epinephrine 25, Epinephrine 50 and epinephrine 100 in people with Spinal Anesthesia, run by Seoul Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the sensory level of spinal anesthesia, the quality of intraoperative analgesia (time frame: every 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2011.