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.: PACTR201701002007277 Date of Approval: 30/01/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title preperitoneal analgesia in Cesarean Section
Official scientific title Preperitoneal post-cesarean section bupivacaine analgesia: Comparison between dexamethasone and dexmedetomidine as adjuvants.
Brief summary describing the background and objectives of the trial Pain is a complex multifactorial phenomenon. Therefore, combinations of different analgesic techniques and medications acting on different target sites may offer excellent dynamic pain relief and reduced adverse effects. Local anesthesia (LA) alone be short-lived. Adjuvants may prolong the LA analgesia. The administration of a steroid could be promising. dexamethasone combined with bupivacaine produced reversible nerve blockade without long term deficits. Dexmedetomidine (trade name Precedex®, Hospira, Inc., Lake Forest, IL) is an ¿2 adrenergic receptor agonist. Perineural dexmedetomidine prolongs motor block by 87%, and increases the time to first analgesic request by 70% compared with LA alone. Dexmedetomidine exhibit a facilitatory effect when administered peripherally. We proposed that preperitoneal dexamethasone and dexmedetomidine with bupivacaine can extend post-CS analgesia. Aim of the work: to evaluate the efficacy of dexamethasone and dexmedetomidine with preperitoneal bupivacaine in post-cesarean section pain relief.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cesarean Section
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 10/04/2016
Actual trial start date 10/04/2016
Anticipated date of last follow up 30/01/2017
Actual Last follow-up date 30/01/2017
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
R/16.03.90 Institutional Review Board, Faculty of Medicine, Mansoura university, Egypt
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 closed envelop method 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 Dexmedetomidine Group 1 microgram/Kg dexmeditomidine+ bupivacaine 0.7mg/Kg 24 hours preperitoneal analgesia 28
Experimental Group Dexamethasone. Group 8 mg dexamethasone +0.7mg/Kg bupivacaine 24 hours preperitoneal analgesia 28
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients scheduled for elective CS under general anesthesia. Including: different parity, presentation, body mass index (BMI) ASA status I-II. 1. Patient refusal. 2. Patients with relevant drug allergy. 3. Pre-eclampsia and eclampsia. 4. History of drug abuse. 5. Patients with psychiatric disorders. 6. Local area infection. 7. Inability for peritoneal closure. 8. Inability of communication. 9. Hepatic, renal, respiratory, cardiac impairments 18 Year(s) 40 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 05/04/2016 Institutional Research Board (IRB), faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
faculty of medicine, Building A, first floor Mansoura 002050 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The time to first request of analgesia postoperative
Secondary Outcome pain assessment by NRS (2, 4, 6, 8, 10, 12, 18, 24 h).postoperatively
Secondary Outcome Ketorolac consumption postoperative through 24 hours
Secondary Outcome Nalbuphine consumption postoperative through 24 hours
Secondary Outcome Mean arterial pressure (2, 4, 6, 8, 10, 12, 18, 24 h). postoperative
Secondary Outcome Heart Rate (2, 4, 6, 8, 10, 12, 18, 24 h). postoperative
Secondary Outcome The cost of analgesic drugs. after 24 hours
Secondary Outcome The number of preperitoneal injections during first 24 hours
Secondary Outcome Side effects (nausea, vomiting, pruritus and sedation) during first 24 hours
Secondary Outcome Anti emetic utilization (metoclopramide 10 mg, ondansterone 4 mg ) in the first 24 hours
Secondary Outcome incidence of Wound infection. during first week postoperative
Secondary Outcome patient satisfaction in a score 0-10 after 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura Integrated Fertility Center kanat elsweis atreet Mansoura 002050 Egypt
mansoura university hospital Al Gomhouria street Mansoura 002050 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mansoura university hospital Al Gomhouria street Mansoura 002050 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mansoura university hospital al Gomhouria street Mansoura 002050 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mona Gad faculty of medicine , al Gomhouria street Mansoura 002050 Egypt
Mohamed Bedairy al Gomhouria street Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alaa Mazy alaa_mazy@yahoo.com 002050 01140065052 faculty of medicine, Al Gomhouria street
City Postal code Country Position/Affiliation
Mansoura 002050 Egypt associate profesor of anesthesia and surgical intensive care
Role Name Email Phone Street address
Public Enquiries Alaa Mazy alaa_mazy@yahoo.com 002050 01140065052 faculty of medicine, Al Gomhouria street
City Postal code Country Position/Affiliation
Mansoura 002050 Egypt associate profesor of anesthesia and surgical intensive care
Role Name Email Phone Street address
Scientific Enquiries Alaa Mazy alaa_mazy@yahoo.com 002050 01140065052 faculty of medicine, Al Gomhouria street
City Postal code Country Position/Affiliation
Mansoura 002050 Egypt associate profesor of anesthesia and surgical intensive care
REPORTING
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