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.: PACTR201701001924325 Date of Approval: 18/12/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title analgesia for mastectomy surgery
Official scientific title Potential Analgesia of Lumber Intrathecal Fentanyl in Breast Cancer Surgery.
Brief summary describing the background and objectives of the trial Various regional anesthetic techniques are used during mastectomy for reduction of pain and side effects. Intrathecal (IT) lumbar opioids have been used for analgesia during thoracotomy and cardiac surgery but not for breast surgery. Our proposal is that lumber IT fentanyl (F), through cephalade spread, may provide analgesia at thoracic level. Meanwhile the IT route is easy to access with avoidance of pneumothorax and failure rate or using machines. we comared 2 groups: 1-Group C: given general anesthesia only. 2-Group IT: given intrathecal 20 mg 0.5% heavy bupivacaine plus 25 mcg Fentanyl, in lateral position to enhance cephalade spread in epsilateral side for surgery. Analgesia was assessed intra and postoperatively, hemodynamics, side effects as nausea and itching for 24h.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied breast cancer surgery,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 27/06/2016
Actual trial start date 27/06/2016
Anticipated date of last follow up 01/11/2015
Actual Last follow-up date 01/11/2016
Anticipated target sample size (number of participants) 44
Actual target sample size (number of participants) 52
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 randomization sealed envelopes method Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group intrathecal analgesia 20 mg bupivacaine+ 25 mcg Fentanyl preoperative lumber intrathecal injection at 3-4L or 2-3L level in lateral position 22 Active-Treatment of Control Group
Control Group general anesthesia diprivan, atracurium 0.5 mg/kg, fentanyl 1 mcg/kg intraoperative induction, intubation, maintenance 22 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- female patients, - (ASA) physical status grade I-II, - with breast cancer scheduled for elective unilateral modified radical mastectomy. Patient refusal, inability to comprehend pain scale, localized or systemic sepsis, low platelets count (< 100,000 /microliter), coagulopathy, deformity or surgery interfering with spinal technique. 18 Year(s) 65 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 26/06/2016 Institutional Research Board (IRB), faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Al Gysh street Mansoura 002050 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the time to first request of analgesia and VAS at 0.5, 1, 3, 6, 9, 12 and 24 hours postoperatively
Secondary Outcome hemodynamics: HR, MAP at 0.5, 1, 3, 6, 9, 12 and 24 hours postoperatively
Secondary Outcome SaO2 at 0.5 and 1 hour postoperatively
Secondary Outcome The range of arm movement. at 0.5, 1, 3, 6, 9, 12 and 24 hours postoperatively
Secondary Outcome total analgesic requirements through 24 h postoperatively
Secondary Outcome Induction stress response. at 1,2,5 min after induction of anesthesia
Secondary Outcome Ephedrine requirements perioperatively
Secondary Outcome Postoperative complications: Nausea & vomiting, pruritus postoperative through 24 h.
Secondary Outcome Upper level of sensory loss. 15 min after intrathecal injection
Secondary Outcome fentanyl dose required intraoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Oncology Center Mansoura University (OCMU). Gehan street Mansoura 002050 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Oncology Center Mansoura University Gehan street Mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oncology Center Mansoura University Gehan street Mansoura Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Hosam I. Saber mansoura faculty of medicine Mansoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator alaa mazy alaa_mazy@yahoo.com 002050 01140065052 mansoura faculty of medicine
City Postal code Country Position/Affiliation
Mansoura Egypt associate profesor of anesthesia and surgical intensive care
Role Name Email Phone Street address
Public Enquiries alaa mazy alaa_mazy@yahoo.com 002 01140065052 Oncology center Mansoura University, Gehan street
City Postal code Country Position/Affiliation
Mansoura 002050 Egypt associate profesor of anestheia and surgical intensive care
Role Name Email Phone Street address
Scientific Enquiries Alaa Mazy alaa_mazy@yahoo.com 002 01140065052 Oncology center Mansoura University, Gehan street
City Postal code Country Position/Affiliation
Mansoura 002050 Egypt associate profesor of anestheia and surgical intensive care
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
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information