Postoperative PainNCT00199316
Postoperative Pain Control After Kidney Surgery : a Comparison of Intrathecal Morphine Plus PCA and PCA Only
A study testing spinal morphine in people with Postoperative Pain, run by Khon Kaen University at 1 site in Thailand.
Trial summary
postoperative pain after kidney surgery is very high. We always use PCA for postopertive pain. But almost patients still had severe pain. We try to use spinal morphine before operation aims to reduce pain. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- spinal morphine
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2005to Nov 2005
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- kidney surgery who less than 60 years old.
- no underlying disease
- ASA less than 3
Who cannot join
- refuse spinal morphine
- history of morphine allery
Trial locations and contacts
1 site in 1 country.
Polpun Boonmak, MD contact
Thailand1 site, 1 recruiting
- Recruiting
Khon Kaen university, Srinagarind Hospital
Muang, Changwat Khon Kaen, 40002
Polpun Boonmak, MD, polpun@hotmail.com
Polpun Boonmak, MD
About this study
postoperative pain after kidney surgery is very high. We always use PCA for postopertive pain. But almost patients still had severe pain. We try to use spinal morphine before operation aims to reduce pain.
- Conditions
- Postoperative Pain
- Being tested
- spinal morphine
- Keywords
- patient who recieve kidney surgery and Patient controlled anesthesia with spinal morphine, intrathecal
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal morphineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
Measured: 48 hours
Secondary outcomes (2)
morphine consumption in PCA
Measured: 48 hours
side effect
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Investigators
- Polpun Boonmak, MD, Study director, lecturer in Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199316
- Sponsor's protocol ID
- I48015
- Status last verified
- Oct 2007
- First submitted
- 14 Sep 2005
- Last updated
- 21 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Control After Kidney Surgery : a Comparison of Intrathecal Morphine Plus PCA and PCA Only
- ClinicalTrials.gov ID
- NCT00199316
- Acronym / sponsor ID
- I48015
- Conditions
- Postoperative Pain
- Keywords
- patient who recieve kidney surgery and Patient controlled anesthesia with spinal morphine, intrathecal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Nov 2005
- First posted
- 20 Sep 2005 (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.
postoperative pain after kidney surgery is very high. We always use PCA for postopertive pain. But almost patients still had severe pain. We try to use spinal morphine before operation aims to reduce pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- kidney surgery who less than 60 years old.
- no underlying disease
- ASA less than 3
Key exclusion criteria (2 listed)
- refuse spinal morphine
- history of morphine allery
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 |
|---|---|---|
| spinal morphine | Drug | – |
Primary outcome
pain score
Time frame: 48 hours
2 secondary outcomes
morphine consumption in PCA
Time frame: 48 hours
side effect
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
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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.
Polpun Boonmak, MD contact
Polpun Boonmak, MD study director
lecturer in Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal morphine in people with Postoperative Pain, run by Khon Kaen University at 1 site in Thailand.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Mar 2018. 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 Thailand. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Polpun Boonmak, MD (polpun@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score (time frame: 48 hours). 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 21 Mar 2018.