Protective Analgesia for Postoperative Pain Relief Following Day Case Oral Surgery

Not Applicable

Completed

• Conditions: Postoperative Pain; Wisdom Tooth
• Interventions: Drug: ibuprofen; Drug: Brufen retard; Drug: Bupivacaine

• Registration Number: NCT00895843
• Lead Sponsor: University of Manchester

Brief 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.

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 Timeline

• Study Start: 2006-11
• Primary Completion: 2007-12
• Study Completion: 2008-01
• Study First Submitted: 2009-03-24
• Study First Submitted QC: 2009-03-24
• Results First Submitted: 2009-03-24
• Results First Submitted QC: 2009-03-24
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-07
• Study First Posted: 2009-05-08
• Results First Posted: 2009-05-08
• Last Update Posted: 2009-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional ibuprofen	ibuprofen	-
Brufen retard	Brufen retard	-
Conventional ibuprofen	Bupivacaine	-
Brufen retard	Bupivacaine	-

Primary Outcome Measures

Name	Time	Method
Number of Patients Needing Rescue Medication	At 6 hours	Number of patients who required rescue medication within 6 hours

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Central Manchester and Manchester Children's NHS University Hospitals; 🇬🇧 Manchester, Lancashire, United Kingdom

Central Manchester NHS Foundation Trust; 🇬🇧 Manchester, Lancashire, United Kingdom