Protective Analgesia for Postoperative Pain Relief Following Day Case Oral Surgery

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895843
• Other study ID #: 9938
• Status: Completed
• Phase: N/A
• First received: March 24, 2009
• Last updated: May 7, 2009
• Start date: November 2006
• Est. completion date: January 2008

Study information

• Verified date: May 2009
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: January 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Wisdom Tooth

Intervention

Drug:
• Brufen retard
Single dose 2 x 800mg tablets 2 hours prior to surgery
• ibuprofen
Single dose ibuprofen 2 x 200mg tablets 2 hours prior to surgery
• 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.

Locations

Country	Name	City	State
United Kingdom	Central Manchester and Manchester Children's NHS University Hospitals	Manchester	Lancashire
United Kingdom	Central Manchester NHS Foundation Trust	Manchester	Lancashire

Sponsors (2)

Lead Sponsor	Collaborator
University of Manchester	Central Manchester University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Needing Rescue Medication		At 6 hours	Yes
Secondary	Mean Pain Intensity		30 mins, 1 hour, 6 hours, 24 hours and 48 hours after surgery	No
Secondary	Time to Rescue		Between 30mins and 48 hours	No
Secondary	Pain Control/Relief		48 hours after surgery (end of study)	No