Postoperative PainNCT02196727
Evaluation of Postoperative Pain Following Bascom Cleft Lift Operation
An observational study of Postoperative Pain, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to evaluate postoperative pain in Bascom Cleft Lift operation receiving multimodal analgesia in day-case surgery setting. Hypothesis: Multimodal analgesia provides adequate pain relief in patients undergoing Bascom Cleft Lift operation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- May 2013to Apr 2014
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing Bascom Cleft Lift operation in a day-case surgery setting
Who may be able to join
- Age > 18
- ASA physical status 1 and 2
- Patient undergoing Bascom operation in prone position
Who cannot join
- Pregnancy
- Current regular use of drug belonging to the class of opioids
- Allergy/ intolerance to drugs included in multimodal analgesia regime
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Post-operative Pain in Bascom Cleft Lift Operation Receiving Multimodal Analgesia and Spinal Saddle Block in Day Case Surgery Setting.
The purpose of this study is to evaluate postoperative pain in Bascom Cleft Lift operation receiving multimodal analgesia in day-case surgery setting.
Hypothesis: Multimodal analgesia provides adequate pain relief in patients undergoing Bascom Cleft Lift operation.
- Conditions
- Postoperative Pain
- Keywords
- Postoperative pain, Multimodal analgesia, Bascom Cleft Lift, Day-case.
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing Bascom operation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS) pain score (0=no pain, 10= maximum imaginable pain)
Measured: 24 hours postoperatively
Secondary outcomes (1)
Numerical Rating Scale (NRS) pain score (0=no pain, 10= maximum imaginable pain)
Measured: 2 hours, 48 hours and 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startMay 2013
- Primary completionJan 2014
- Study completionApr 2014
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saphana Jassim Mohamed, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196727
- Sponsor's protocol ID
- BPP
- Status last verified
- May 2013
- First submitted
- 18 Jul 2014
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Mohamed SJ, Kristensen BB, Lindgaard L, Bisgaard T. Acceptable effect of multimodal analgesic treatment after a Bascom cleft lift operation. Dan Med J. 2015 Jan;62(1):A4985.
PubMed 25557329
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-operative Pain in Bascom Cleft Lift Operation Receiving Multimodal Analgesia and Spinal Saddle Block in Day Case Surgery Setting.
- ClinicalTrials.gov ID
- NCT02196727
- Acronym / sponsor ID
- BPP
- Conditions
- Postoperative Pain
- Keywords
- Postoperative pain, Multimodal analgesia, Bascom Cleft Lift, Day-case.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 22 Jul 2014 (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 postoperative pain in Bascom Cleft Lift operation receiving multimodal analgesia in day-case surgery setting.
Hypothesis: Multimodal analgesia provides adequate pain relief in patients undergoing Bascom Cleft Lift operation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing Bascom operation | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing Bascom Cleft Lift operation in a day-case surgery setting
Key inclusion criteria (3 listed)
- Age > 18
- ASA physical status 1 and 2
- Patient undergoing Bascom operation in prone position
Key exclusion criteria (3 listed)
- Pregnancy
- Current regular use of drug belonging to the class of opioids
- Allergy/ intolerance to drugs included in multimodal analgesia regime
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Numerical Rating Scale (NRS) pain score (0=no pain, 10= maximum imaginable pain)
Time frame: 24 hours postoperatively
1 secondary outcome
Numerical Rating Scale (NRS) pain score (0=no pain, 10= maximum imaginable pain)
Time frame: 2 hours, 48 hours and 30 days postoperatively
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 22 Jul 2014.
- Derived from this study: PubMed 25557329Mohamed SJ, Kristensen BB, Lindgaard L, Bisgaard T. Acceptable effect of multimodal analgesic treatment after a Bascom cleft lift operation. Dan Med J. 2015 Jan;62(1):A4985.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Hvidovre University Hospital at 1 site in Denmark.
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 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 22 Jul 2014. 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 Denmark. 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?
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?
Numerical Rating Scale (NRS) pain score (0=no pain, 10= maximum imaginable pain) (time frame: 24 hours postoperatively). 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 NCT02196727, 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 22 Jul 2014.