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Completed

NCT Number: NCT00895843

Protective Analgesia for Postoperative Pain Relief Following Day Case Oral Surgery

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Wisdom Tooth

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Manchester NHS Foundation Trust, Manchester, Lancashire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brufen retard

Drug

Single dose 2 x 800mg tablets 2 hours prior to surgery

Other names: sustained release ibuprofen, modified release ibuprofen

Ibuprofen

Drug

Single dose ibuprofen 2 x 200mg tablets 2 hours prior to surgery

Other names: Brufen, neurofen, conventional release ibuprofen

Bupivacaine

Drug

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

Primary outcomes

  1. Number of Patients Needing Rescue Medication

    Time frame: At 6 hours

    Number of patients who required rescue medication within 6 hours

Secondary outcomes

  1. Mean Pain Intensity

    Time frame: 30 mins, 1 hour, 6 hours, 24 hours and 48 hours after surgery

    Mean VAS scores of pain intensity for each time points

  2. Time to Rescue

    Time frame: Between 30mins and 48 hours

    Time taken for rescue medication requirement

  3. Pain Control/Relief

    Time frame: 48 hours after surgery (end of study)

    Patient satisfaction scores

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Collaborators

  • Manchester University NHS Foundation Trust

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
May 8, 2009
Registry last updated
Jun 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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