Protective Analgesia for Postoperative Pain Relief Following Day Case Oral Surgery

University of Manchester122 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

122

Conditions

Postoperative Pain Wisdom Tooth

Interventions

Brufen retardDRUG

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

ibuprofenDRUG

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

BupivacaineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Central Manchester and Manchester Children's NHS University Hospitals

Manchester, Lancashire, United Kingdom

Central Manchester NHS Foundation Trust

Manchester, Lancashire, United Kingdom

Outcomes

Primary Outcomes

Number of Patients Needing Rescue Medication

Number of patients who required rescue medication within 6 hours

Time frame: At 6 hours

Secondary Outcomes

Mean Pain Intensity

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

Time to Rescue

Time taken for rescue medication requirement

Time frame: Between 30mins and 48 hours

Pain Control/Relief

Patient satisfaction scores

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

Data from ClinicalTrials.gov

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