Postoperative PainNCT00895843
Protective Analgesia for Postoperative Pain Relief Following Day Case Oral Surgery
A study testing Brufen retard, ibuprofen and Bupivacaine in people with Postoperative Pain and Wisdom Tooth, run by University of Manchester at 2 sites in United Kingdom.
Trial summary
The purpose of this study is to investigate whether robust analgesic regime (protective analgesia) can improve postoperative pain experience for patients undergoing lower wisdom teeth extraction under day case general anaesthetic. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Wisdom Tooth
- What is being tested?
- Brufen retard, ibuprofen and Bupivacaine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Nov 2006to Jan 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy male and female patients aged 18 years and over
- patients requiring removal of one or more third molars, with at lease one completely or partially impacted in the mandible needing bone removal
Who cannot join
- history of allergy to NSAIDs
- pregnant
- history of GI disease
- history of bleeding disorders
- alcohol dependancy
- drug abuse
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Central Manchester and Manchester Children's NHS University Hospitals
Manchester, Lancashire, M13 9PL
Central Manchester NHS Foundation Trust
Manchester, Lancashire, M13 9PL
About this study
Official title: Protective Analgesia Using Bupivacaine and Conventional Release Ibuprofen Versus Bupivacaine and Sustained Release Ibuprofen for Postoperative Pain Relief in Patients Undergoing Third Molar Surgery: a Randomised Controlled Trial
The purpose of this study is to investigate whether robust analgesic regime (protective analgesia) can improve postoperative pain experience for patients undergoing lower wisdom teeth extraction under day case general anaesthetic.
Read the detailed description
The aim of the study was to demonstrate and improve postoperative pain experience using protective analgesia for patients undergoing oral surgery under day case general anaesthesia.
The primary objective was to investigate the efficiency of protective analgesia using combined effects of sustained release ibuprofen and bupivacaine nerve block in attenuation of postoperative pain following impacted third molar surgery under day case general anaesthesia.
The secondary objective was to document the safety and tolerability profile of conventional release versus sustained released ibuprofen with bupivacaine block in subjects undergoing impacted third molar surgery under day case general anaesthesia.
- Conditions
- Postoperative Pain, Wisdom Tooth
- Being tested
- Brufen retard, ibuprofen, Bupivacaine
- Keywords
- Third molar
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brufen retardDrug
Also called sustained release ibuprofen, modified release ibuprofen
Single dose 2 x 800mg tablets 2 hours prior to surgery
ibuprofenDrug
Also called Brufen, neurofen, conventional release ibuprofen
Single dose ibuprofen 2 x 200mg tablets 2 hours prior to surgery
BupivacaineDrug
Also called Marcain 0.5% with 1 in 200,000 epinephrine
Up to 10ml of Bupivacaine 0.5% with 1:200,000 Adrenaline given prior to surgical incision as inferior alveolar nerve block and long buccal nerve infiltration.
| Study group | Role | What they receive |
|---|---|---|
| Conventional ibuprofen | Active comparator | Not described Receives: Drug: ibuprofen; Drug: Bupivacaine |
| Brufen retard | Experimental | Not described Receives: Drug: Brufen retard; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Needing Rescue Medication
Number of patients who required rescue medication within 6 hours
Measured: At 6 hours
Secondary outcomes (3)
Mean Pain Intensity
Mean VAS scores of pain intensity for each time points
Measured: 30 mins, 1 hour, 6 hours, 24 hours and 48 hours after surgery
Time to Rescue
Time taken for rescue medication requirement
Measured: Between 30mins and 48 hours
Pain Control/Relief
Patient satisfaction scores
Measured: 48 hours after surgery (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startNov 2006
- Primary completionDec 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Investigators
- Paul Coulthard, BDS FDS PhD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895843
- Sponsor's protocol ID
- 9938
- Status last verified
- May 2009
- First submitted
- 24 Mar 2009
- Last updated
- 1 Jun 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Analgesia Using Bupivacaine and Conventional Release Ibuprofen Versus Bupivacaine and Sustained Release Ibuprofen for Postoperative Pain Relief in Patients Undergoing Third Molar Surgery: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00895843
- Acronym / sponsor ID
- 9938
- Conditions
- Postoperative Pain, Wisdom Tooth
- Keywords
- Third molar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Study start
- Nov 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 8 May 2009 (estimated)
- Results
- Posted 8 May 2009
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 investigate whether robust analgesic regime (protective analgesia) can improve postoperative pain experience for patients undergoing lower wisdom teeth extraction under day case general anaesthetic.
Detailed description
The aim of the study was to demonstrate and improve postoperative pain experience using protective analgesia for patients undergoing oral surgery under day case general anaesthesia.
The primary objective was to investigate the efficiency of protective analgesia using combined effects of sustained release ibuprofen and bupivacaine nerve block in attenuation of postoperative pain following impacted third molar surgery under day case general anaesthesia.
The secondary objective was to document the safety and tolerability profile of conventional release versus sustained released ibuprofen with bupivacaine block in subjects undergoing impacted third molar surgery under day case general anaesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional ibuprofen | Active comparator | Drug: ibuprofen, Drug: Bupivacaine |
| Brufen retard | Experimental | Drug: Brufen retard, Drug: Bupivacaine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy male and female patients aged 18 years and over
- patients requiring removal of one or more third molars, with at lease one completely or partially impacted in the mandible needing bone removal
Key exclusion criteria (6 listed)
- history of allergy to NSAIDs
- pregnant
- history of GI disease
- history of bleeding disorders
- alcohol dependancy
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 |
|---|---|---|
| Brufen retardAlso: sustained release ibuprofen, modified release ibuprofenSingle dose 2 x 800mg tablets 2 hours prior to surgery | Drug | Brufen retard |
| ibuprofenAlso: Brufen, neurofen, conventional release ibuprofenSingle dose ibuprofen 2 x 200mg tablets 2 hours prior to surgery | Drug | Conventional ibuprofen |
| BupivacaineAlso: Marcain 0.5% with 1 in 200,000 epinephrineUp to 10ml of Bupivacaine 0.5% with 1:200,000 Adrenaline given prior to surgical incision as inferior alveolar nerve block and long buccal nerve infiltration. | Drug | Brufen retard, Conventional ibuprofen |
Primary outcome
Number of Patients Needing Rescue Medication
Time frame: At 6 hours
Number of patients who required rescue medication within 6 hours
3 secondary outcomes
Mean Pain Intensity
Time frame: 30 mins, 1 hour, 6 hours, 24 hours and 48 hours after surgery
Time to Rescue
Time frame: Between 30mins and 48 hours
Pain Control/Relief
Time frame: 48 hours after surgery (end of study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Paul Coulthard, BDS FDS PhD principal investigator
University of Manchester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brufen retard, ibuprofen and Bupivacaine in people with Postoperative Pain and Wisdom Tooth, run by University of Manchester at 2 sites in United Kingdom.
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 6 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 1 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Yes. Results are posted in the registry (first posted 8 May 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients Needing Rescue Medication (time frame: At 6 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 1 Jun 2009.