Pain MeasurementNCT01172782
The Analgesic Effect of Intrathecal Hydromorphone Injection on Spinal Anesthesia
A study testing Hydromorphone in people with Pain Measurement and Visual Analog Pain Scale, run by Korea University Anam Hospital.
Trial summary
The purpose of this study is to evaluate the adequate dose of intrathecal hydromorphone injection for postoperative pain relief after knee arthroscopic surgery. Read more about this study
- Who is it for?
- Ages 18 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Measurement, Visual Analog Pain Scale
- What is being tested?
- Hydromorphone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Jul 2010
- 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 18 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA class I-II (age range: 18-72 years)
- Informed consent obtained patients
Who cannot join
- 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
About this study
The purpose of this study is to evaluate the adequate dose of intrathecal hydromorphone injection for postoperative pain relief after knee arthroscopic surgery.
Read the detailed 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.
- Conditions
- Pain Measurement, Visual Analog Pain Scale
- Being tested
- Hydromorphone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydromorphoneDrug
2.5, 5, 10 ug of hydromorphone, intrathecal injection, single injection. duration of intrathecal injection are not fully studied.
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | control group (CG) received 6 mg of hyperbaric bupivacaine and 0.05 mL of saline. Receives: Drug: Hydromorphone |
| 2.5 ug hydromorphone recieved group | Active comparator | 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 Receives: Drug: Hydromorphone |
| 5 μg hydromorphone group | Active comparator | 5 μg hydromorphone group received 1.2 mL of 0.5% hyperbaric bupivacaine and 5 μg of hydromorphone in 0.05 mL of saline Receives: Drug: Hydromorphone |
| the 10 μg hydromorpnone group | Active comparator | 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. Receives: Drug: Hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analgesic Numberic Score
Measured: during postoperative recovery period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startJul 2009
- Primary completionFeb 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain MeasurementStudies 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172782
- Sponsor's protocol ID
- minware2
- Status last verified
- Jan 2010
- First submitted
- 28 Jul 2010
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee YS, Park YC, Kim JH, Kim WY, Yoon SZ, Moon MG, Min TJ. Intrathecal hydromorphone added to hyperbaric bupivacaine for postoperative pain relief after knee arthroscopic surgery: a prospective, randomised, controlled trial. Eur J Anaesthesiol. 2012 Jan;29(1):17-21. doi: 10.1097/EJA.0b013e3283476055.
PubMed 21562420
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Effect of Intrathecal Hydromorphone Injection on Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT01172782
- Acronym / sponsor ID
- minware2
- Conditions
- Pain Measurement, Visual Analog Pain Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- Korea University
- Study start
- Jul 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 30 Jul 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.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: Hydromorphonecontrol group (CG) received 6 mg of hyperbaric bupivacaine and 0.05 mL of saline. |
| 2.5 ug hydromorphone recieved group | Active comparator | Drug: Hydromorphonethe 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 |
| 5 μg hydromorphone group | Active comparator | Drug: Hydromorphone5 μg hydromorphone group received 1.2 mL of 0.5% hyperbaric bupivacaine and 5 μg of hydromorphone in 0.05 mL of saline |
| the 10 μg hydromorpnone group | Active comparator | Drug: Hydromorphonethe 10 μg hydromorphone group received 1.2 mL of 0.5% hyperbaric bupivacaine and 10 μg of hydromorphone in 0.05 mL of saline. |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA class I-II (age range: 18-72 years)
- Informed consent obtained patients
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Hydromorphone2.5, 5, 10 ug of hydromorphone, intrathecal injection, single injection. duration of intrathecal injection are not fully studied. | Drug | 2.5 ug hydromorphone recieved group, 5 μg hydromorphone group, control group, the 10 μg hydromorpnone group |
Primary outcome
Visual Analgesic Numberic Score
Time frame: during postoperative recovery period.
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 27 Jun 2011.
- Derived from this study: PubMed 21562420Lee YS, Park YC, Kim JH, Kim WY, Yoon SZ, Moon MG, Min TJ. Intrathecal hydromorphone added to hyperbaric bupivacaine for postoperative pain relief after knee arthroscopic surgery: a prospective, randomised, controlled trial. Eur J Anaesthesiol. 2012 Jan;29(1):17-21. doi: 10.1097/EJA.0b013e3283476055.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hydromorphone in people with Pain Measurement and Visual Analog Pain Scale, run by Korea University Anam Hospital.
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 2 inclusion and 1 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 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Visual Analgesic Numberic Score (time frame: during postoperative recovery period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01172782, which also lists 1 linked publication.
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 27 Jun 2011.