Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201812526365048 Date of Approval: 06/12/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Post intra-alveolar extraction pain control with Bupivacaine and Lidocaine
Official scientific title Post intra-alveolar extraction analgesia of Bupivacaine and Lidocaine: A randomized controlled clinical trial
Brief summary describing the background and objectives of the trial Pain is a common complaint after tooth extraction which usually occurs in the first six to twelve hours following the procedure. The aim of this study was to evaluate the efficacy of 0.5% bupivacaine in controlling post-operative pain following intra-alveolar tooth extraction and to compare it with 2% lidocaine.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 08/09/2015
Actual trial start date 08/09/2015
Anticipated date of last follow up 09/08/2016
Actual Last follow-up date 12/08/2016
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants) 252
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Bupivacaine 0.5 percent 1.8ml of 0.5% Bupivacaine 12 months This study was a double blind randomized controlled trial on 240 adult patients undergoing intra-alveolar tooth extraction. The patients were divided into 2 groups of 120 to receive local anaesthetic agent (LA) of either 0.5% bupivacaine with epinephrine or 2% lidocaine with epinephrine. The patients were prescribed analgesics after the extraction (which they were instructed to take when pain occurred). Pain experience was assessed using numeric rating scale (NRS) at definite points in time; before treatment, 10 mins after administration of LA and at 1,3, 6, 9, 12, 24, 36 and 48 hours post-operatively. Time of commencement and total amount of rescue analgesics were recorded. Patient satisfaction was also recorded using a modified verbal scale. Data were analyzed using Pearson’s chi-square test and P <0.05 was considered statistically significant. 126
Control Group Lidocaine 2 percent 1.8ml of 2% Lidocaine 12 months This study was a double blind randomized controlled trial on 240 adult patients undergoing intra-alveolar tooth extraction. The patients were divided into 2 groups of 120 to receive local anaesthetic agent (LA) of either 0.5% bupivacaine with epinephrine or 2% lidocaine with epinephrine. The patients were prescribed analgesics after the extraction (which they were instructed to take when pain occurred). Pain experience was assessed using numeric rating scale (NRS) at definite points in time; before treatment, 10 mins after administration of LA and at 1,3, 6, 9, 12, 24, 36 and 48 hours post-operatively. Time of commencement and total amount of rescue analgesics were recorded. Patient satisfaction was also recorded using a modified verbal scale. Data were analyzed using Pearson’s chi-square test and P <0.05 was considered statistically significant. 126 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All dental patients of age 18 years and above who required intra-alveolar tooth extraction and who consented to participate in the study. Patients who required surgical removal of the tooth/teeth Patients with history of allergy to bupivacaine or lidocaine. Patients with cognitive problems e.g. mental retardation, cerebral palsy. Patients with underlying systemic diseases such as uncontrolled diabetic mellitus, hypertension. Regular smoker (2 or more sticks per day) and regular/heavy alcohol intake (more than three drinks (1065ml) of beer per day or more than seven drinks (4970ml) of beer per week, more than three drinks (444ml) of wine per day or more than seven drinks (1036ml) of wine per week, more than three drinks (132ml) of distilled spirit per day or more than seven drinks (308ml) of distilled spirit per week).139, 140, 141 Patients who were on antibiotics, oral contraceptive, or steroid therapy Patients who could not read and write. Patients with complicated tooth extraction (more than 30minutes) Patients with tooth mobility greater than grade I Patients with dentoalveolar abscess, orofacial cellulitis or abscess Pregnant patients (bupivacaine crosses the placenta barrier to the baby) Patients with known allergy to adrenaline Patients who declined participation in the study Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/04/2015 UI and UCH Ethical Committee
Ethics Committee Address
Street address City Postal code Country
University College Hospital, Ibadan Ibadan 200001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome post operative pain prevention 1, 2, 3, 6, 9, 12, 24, 36, and 48 hours post operatively
Secondary Outcome Prevention of post operative pain 1, 2, 3, 6, 9, 12, 24, 36, and 48 hours post operatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University College Hospital UCH Orita mefa total garden Ibadan 200001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ADELUSI EMMANUEL ADETOLU UCH IBADAN Ibadan 200001 Nigeria self
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emmanuel Adelusi godwithus73@yahoo.com 2348034659807 UCH Ibadan
City Postal code Country Position/Affiliation
Ibadan 200001 Nigeria Consultant
Role Name Email Phone Street address
Public Enquiries Emmanuel Adelusi godwithus73@yahoo.com 2348034659807 UCH Ibadan
City Postal code Country Position/Affiliation
Ibadan 200001 Nigeria Consultant
Role Name Email Phone Street address
Scientific Enquiries Emmanuel Adelusi godwithus73@yahoo.com 2348034659807 UCH Ibadan
City Postal code Country Position/Affiliation
Ibadan 200001 Nigeria Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information