Protective Analgesia for Postoperative Pain Relief Following Day Case Oral Surgery

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Wisdom Tooth
• Intervention / Treatment: Drug: ibuprofen; Drug: Bupivacaine; Drug: Brufen retard

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 Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Lancashire
    • Manchester, Lancashire, United Kingdom, M13 9PL
      • Central Manchester and Manchester Children's NHS University Hospitals
    • Manchester, Lancashire, United Kingdom, M13 9PL
      • Central Manchester NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Manchester
• Collaborators: Manchester University NHS Foundation Trust
• Investigators: Principal Investigator: Paul Coulthard, BDS FDS PhD, University of Manchester

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: March 24, 2009
• First Submitted That Met QC Criteria: March 24, 2009
• First Posted (Estimate): May 8, 2009

Study Record Updates

• Last Update Posted (Estimate): June 1, 2009
• Last Update Submitted That Met QC Criteria: May 7, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: Third molar
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Bupivacaine; Ibuprofen; Epinephrine
• Other Study ID Numbers: 9938 (Other Identifier: CTEP)