Protective Analgesia for Postoperative Pain Relief Following Day Case Oral Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Postoperative Pain, Wisdom Tooth

Intervention / Treatment
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* Drug: Brufen retard
* Drug: ibuprofen
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: history of allergy to NSAIDs pregnant history of GI disease history of bleeding disorders alcohol dependancy drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional ibuprofen<br> | Drug: ibuprofen<br>* Single dose ibuprofen 2 x 200mg tablets 2 hours prior to surgery<br>* Other names: conventional release ibuprofen;Drug: Bupivacaine<br>* 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.<br>* Other names: Marcain 0.5% with 1 in 200,000 epinephrine;|
| Experimental: Brufen retard<br> | Drug: Brufen retard<br>* Single dose 2 x 800mg tablets 2 hours prior to surgery<br>* Other names: modified release ibuprofen;Drug: Bupivacaine<br>* 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.<br>* Other names: Marcain 0.5% with 1 in 200,000 epinephrine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Needing Rescue Medication | Number of patients who required rescue medication within 6 hours | At 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Pain Intensity | Mean VAS scores of pain intensity for each time points | 30 mins, 1 hour, 6 hours, 24 hours and 48 hours after surgery | 
| Time to Rescue | Time taken for rescue medication requirement | Between 30mins and 48 hours | 
| Pain Control/Relief | Patient satisfaction scores | 48 hours after surgery (end of study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Third molar