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Protective Analgesia for Postoperative Pain Relief Following Day Case Oral Surgery

Primary Purpose

Postoperative Pain, Wisdom Tooth

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Brufen retard

ibuprofen

Bupivacaine

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Third molar

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Central Manchester and Manchester Children's NHS University Hospitals
Central Manchester NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional ibuprofen

Brufen retard

Arm Description

Outcomes

Primary Outcome Measures

Number of Patients Needing Rescue Medication

Number of patients who required rescue medication within 6 hours

Secondary Outcome Measures

Mean Pain Intensity

Mean VAS scores of pain intensity for each time points

Time to Rescue

Time taken for rescue medication requirement

Pain Control/Relief

Patient satisfaction scores

Full Information

NCT ID

NCT00895843

First Posted

March 24, 2009

Last Updated

May 7, 2009

Sponsor

University of Manchester

Collaborators

Manchester University NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT00895843

Brief Title

Protective Analgesia for Postoperative Pain Relief Following Day Case Oral Surgery

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2009

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Manchester

Collaborators

Manchester University NHS Foundation Trust

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain, Wisdom Tooth

Keywords

Third molar

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Conventional ibuprofen

Arm Type

Active Comparator

Arm Title

Brufen retard

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Brufen retard

Other Intervention Name(s)

sustained release ibuprofen, modified release ibuprofen

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

ibuprofen

Other Intervention Name(s)

Brufen, neurofen, conventional release ibuprofen

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Bupivacaine

Other Intervention Name(s)

Marcain 0.5% with 1 in 200,000 epinephrine

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Patients Needing Rescue Medication

Description

Number of patients who required rescue medication within 6 hours

Time Frame

At 6 hours

Secondary Outcome Measure Information:

Title

Mean Pain Intensity

Description

Mean VAS scores of pain intensity for each time points

Time Frame

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

Title

Time to Rescue

Description

Time taken for rescue medication requirement

Time Frame

Between 30mins and 48 hours

Title

Pain Control/Relief

Description

Patient satisfaction scores

Time Frame

48 hours after surgery (end of study)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Coulthard, BDS FDS PhD

Organizational Affiliation

University of Manchester

Official's Role

Principal Investigator

Facility Information:

Facility Name

Central Manchester and Manchester Children's NHS University Hospitals

City

Manchester

State/Province

Lancashire

ZIP/Postal Code

M13 9PL

Country

United Kingdom

Facility Name

Central Manchester NHS Foundation Trust

City

Manchester

State/Province

Lancashire

ZIP/Postal Code

M13 9PL

Country

United Kingdom

12. IPD Sharing Statement

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Protective Analgesia for Postoperative Pain Relief Following Day Case Oral Surgery

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