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.: PACTR201703002140337 Date of Approval: 26/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Regional Anaesthesia
Official scientific title Comparison between bupivacaine alone or in combination with dexmedetomidine for paravertebral block in patients presented for nephrectomy
Brief summary describing the background and objectives of the trial Postoperative pain remains the most common postoperative complication annoying patients. There are several methods for postoperative pain relief as NSAIDs, opioids, nerve block, or others. Despite the high popularity of opioid use to control pain, there are many side effects as nausea and vomiting and respiratory depression, moreover, these side effect are more encountered in renal patients. Patients presented for nephrectomy suffer from severe postoperative pain with limitation of analgesia use due to impaired renal function, thus, regional anesthesia techniques are preferable methods. Nowadays, Paravertebral block is common regional anesthesia technique used for control of thoracic and upper abdominal pain. Routine use of high concentration of plain bupivacine 0.5% in paravertebral block is associated with increased risk of complication especially hemodynamic effects, however, use of low concentration plain bupivacaine in paravertebral block may affect the quality of the block decreasing its analgesic effect. The use of local anesthetic adjuvant with low concentration plain bupivacaine can improve quality of the block while minimizing side effects. Dexmedetomidine, a useful medication with high selective ¿2 adrenreceptor agonist, possess sedative, analgesic, and sympatholytic action.its use as adjunct in neuraxial and regional anesthesia had been increased based upon activation of many antinociceptive mechanisms through activation of ¿2 adrenreceptor. The aim of our study is to compare the use of dexmedtomidine added to low concentration bupivacaine to use of low concentration bupivacaine, and use of high concentration bupivacaine in paravertebralblock in patients presented for nephrectomy. Our primary outcome was efficacy of technique in the form of analgesic effect, while, our secondary outcomes was safety of patients in the form of hemodynamic changes and incidence of complication.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Patients presented for nephrectomy
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/06/2016
Actual trial start date 03/09/2016
Anticipated date of last follow up 30/11/2016
Actual Last follow-up date 05/03/2017
Anticipated target sample size (number of participants) 134
Actual target sample size (number of participants) 90
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 Computer generate randomisation sealed opaque envelops Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group B 0.25% 0.2 mL/Kg of the loading solution (0.25% bupivacaine) injected slowly 24 hours paravertebral block 30
Experimental Group BD 0.25% 0.2 mL/Kg of the loading solution (0.25% bupivacaine + dexmiditomidine 0.5 mic/mL) 24 hours postoperative paravertebral block 30
Experimental Group B 0.5% 0.2 mL/Kg of the loading solution (0.5% bupivacaine) 24 hours Paravertebral block 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA class I or II Aged more than 18 years Patients refusal patients who refused to participate patient refused to five informed written consent patients with systemic or local infection patients with known or suspected coagulopathy patients with hemodynamic instability 18 Year(s) 65 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 30/04/2015 Research Ethics Committee of Tanta Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
1, Elgeish st, Tanta Tanta 31741 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome efficacy of technique in the form of analgesic effect Visual Analogue Scale at the following time intervals during rest and cough - 30 minutes -1 hour -2 hour -4 hours - 6 hours - 12 hours - 18 hours - 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital 1, Elgeish st Tanta 31741 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University Hospital 1, Elgeish st, tanta Tanta 31741 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University Hospital 1, Elgeish st, tanta Tanta 31741 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Amr Ahmed Magdy Abdelfattah Ghouraba st Tanta 31741 Egypt
Muhamed Gamal Almawy Al nady st Tanta 31741 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sameh Abdelkhalik Samehabdelkhalik1982@gmail.com 00201002977048 Saied st
City Postal code Country Position/Affiliation
Tanta 31741 Egypt Lecturer at Tanta University
Role Name Email Phone Street address
Public Enquiries Mohamed Elshazly moshhansaky@Gmail.com 00201226896829 2,Al Galaa st
City Postal code Country Position/Affiliation
Tanta 31741 Egypt Employer at Ministry of Health, Egypt
Role Name Email Phone Street address
Scientific Enquiries Salah Elsherif Salahalsherif505@yahoo.com 00201020150330 In elfared st
City Postal code Country Position/Affiliation
Tanta 31741 Egypt Professor at Tanta University
REPORTING
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