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.: PACTR201511001334385 Date of Approval: 02/11/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Intravenous dexmedetomidine versus a combination of dexmedetomidine and bupivacaine infiltration
Official scientific title A comparison of the postoperative analgesic effects of intravenous dexmedetomidine with a combination of dexmedetomidine and bupivacaine infiltration for lower segment caesarean section- a prospective, randomized, controlled study
Brief summary describing the background and objectives of the trial Background and Aims: Dexmedetomidine potentiate local anaesthetics and have been utilized to enhance postoperative analgesia after direct infiltration of dexmedetomidine in a dose of 1 ¿g/kg as an adjunct to local anaesthetics This study was designed to compare the postoperative analgesic effect of dexmedetomidine administered intravenously or in wound infiltration with bupivacaine in patients undergoing caesarean section.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Postoperative analgesia,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2011
Actual trial start date 23/03/2011
Anticipated date of last follow up 01/11/2013
Actual Last follow-up date 02/11/2013
Anticipated target sample size (number of participants) 90
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 generated random number table Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group 2 Received dexmedetomidine 1 ¿g/kg in 100 ml normal saline infusion over 10 min. before closure plus wound infiltration with 25 ml of 0.25% bupivacaine At the end of surgery. 30
Experimental Group Group 3 Received 100 ml normal saline infusion over 10 min. before closure plus wound infiltration with dexmedetomidine 1 ¿g/kg added to 25 ml of 0.25% bupivacaine. At the end of surgery. 30
Control Group Group 1 Received 100 ml normal saline infusion over 10 min. before closure plus wound infiltration with 25 ml of 0.25% bupivacaine At the end of surgery. 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA grade I and II. Their ages ranged between 19 and 38 years old. Posted for caesarean section. Patients with difficult airway. Morbid obesity. Reynaud¿s disease. Hepatic or renal insufficiency. Hypertension. Preeclampsia. Patients receiving any drugs that may interfere with action of the study drugs 19 Year(s) 38 Year(s) Female
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 04/02/2011 Benha faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Farid Nada st. Benha 230280 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain at rest and on cough assessed by VAS at the time of arrival in PACU and then after 2, 4, 6, 12, and 24 h after operation
Secondary Outcome number of patients requiring rescue analgesia during the first 24 h after operation
Secondary Outcome Total morphine consumption During the first 24 hours
Secondary Outcome Level of sedation was assessed by using the four point sedation score In the first 24 hours
Secondary Outcome Adverse effects in the first 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Benha university Farid Nada st. Benha 230280 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Benha faculty of medicine Farid Nada st Benha 230280 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Benha faculty of medicine Farid Nada st. Benha 230280 Egypt Hospital
Secondary Sponsor Benha university Farid Nada st. Benha 230280 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Gynacology and obestetric department- Benha faculty of medicine Farid Nada st. Benha 230280 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Mostafa Abd El-Hamid bashaahmad@yahoo.com 00201005204130 20 Ezz Eldin Omar st.
City Postal code Country Position/Affiliation
Giza 12111 Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries Mohamed Abd El-Fattah drmha1000@yahoo.com 00966538144174 Kafr Sokr- Benha
City Postal code Country Position/Affiliation
Benha Egypt Lecturer
Role Name Email Phone Street address
Scientific Enquiries Saad Ibrahim Saad saadibrahim_7@yahoo.com 00201223142889 Oman st.
City Postal code Country Position/Affiliation
Giza Egypt Professor of anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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