Text Size

Protective Analgesia for Postoperative Pain Relief Following Day Case Oral Surgery

This study has been completed.
Sponsor:
Collaborator:
Central Manchester University Hospitals NHS Foundation Trust
Information provided by:
University of Manchester
ClinicalTrials.gov Identifier:
NCT00895843
First received: March 24, 2009
Last updated: May 7, 2009
Last verified: May 2009
History of Changes
  Purpose

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.


Condition Intervention
Postoperative Pain
Wisdom Tooth
 Drug: Brufen retard
Drug: ibuprofen
Drug: Bupivacaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Manchester:

Primary Outcome Measures:
  • Number of Patients Needing Rescue Medication [ Time Frame: At 6 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean Pain Intensity [ Time Frame: 30 mins, 1 hour, 6 hours, 24 hours and 48 hours after surgery ] [ Designated as safety issue: No ]
  • Time to Rescue [ Time Frame: Between 30mins and 48 hours ] [ Designated as safety issue: No ]
  • Pain Control/Relief [ Time Frame: 48 hours after surgery (end of study) ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: November 2006
Study Completion Date: January 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Marcain 0.5% with 1 in 200,000 epinephrine
Experimental: Brufen retard Drug: Brufen retard
Single dose 2 x 800mg tablets 2 hours prior to surgery
Other Names:
  • sustained release ibuprofen
  • modified 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 Name: Marcain 0.5% with 1 in 200,000 epinephrine

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895843

Locations
United Kingdom
Central Manchester NHS Foundation Trust
Manchester, Lancashire, United Kingdom, M13 9PL
Central Manchester and Manchester Children's NHS University Hospitals
Manchester, Lancashire, United Kingdom, M13 9PL
Sponsors and Collaborators
University of Manchester
Central Manchester University Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Paul Coulthard, BDS FDS PhD University of Manchester
  More Information

No publications provided

Responsible Party: Professor Paul Coulthard, University of Manchester
ClinicalTrials.gov Identifier: NCT00895843     History of Changes
Other Study ID Numbers: 9938
Study First Received: March 24, 2009
Results First Received: March 24, 2009
Last Updated: May 7, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Manchester:
Third molar

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Bupivacaine
Ibuprofen
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013