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.: PACTR201703002123104 Date of Registration: 23/03/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title blood conservation and analgesia in kyphoscoliotic surgery
Official scientific title High volume, multilevel local anesthetics-Epinephrine infiltration in kyphoscoliotic surgery: Blood conservation and analgesia
Brief summary describing the background and objectives of the trial Kyphoscoliosis correction accounts for massive blood loss that may exceed more than half of blood volume. There are many strategies for blood conservation; however sometimes some of them may not be suitable. For the purpose of analgesia and decreasing bleeding, the use of local anesthetic with epinephrine is a standard practice in spine surgery. local anesthetic infiltration was first applied over 35 years ago in lumbar spine surgery. However meta-analysis of data reviled inconclusive and heterogeneous efficacy results. This conflict arise from the differences in the technique and drugs. There are three levels of infiltration; subcutaneous, muscular and perineural. Its timing either pre-incision or post-surgery. Our proposal is that using epinephrine aids bleeding control. Concomitantly, Bupivacaine infiltration at three levels; subcutaneous, muscular and paraspinal provides analgesia. In addition, this drug combination may help to maintain spinal cord perfusion by avoiding deliberate hypotension. A high volume sufficient for proper tissue infiltration at three anatomically guided levels has not been described so far. This research may benefit all spine surgery patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Kyphoscoliosis surgery,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 12/03/2017
Actual trial start date 12/03/2017
Anticipated date of last follow up 30/06/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 44
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
R/17.02.85 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 randomization 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
Control Group saline infiltration 100 ml for every 10 cm wound length 24 hours general aneathesia group 22 Placebo
Experimental Group local infiltration group Bupivacaine 2 mg/Kg + Lidocaine 5 mg/Kg.+ Epinephrine 5 mcg/ml + normal saline to a total volume of 100 ml/10 cm of the wound length 24 hours local anesthetic- vasoconstrictor infiltration 22 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Kyphoscolioisis patients subjected for spinal correction. -ASA I-II status - Patient or parents refusal. - Infection at surgical site. - Hypersensitivity to amide local anesthetics. - Coagulopathy. - Blood diseases as sickle cell anemia, hemophilia, idiopatathic thrombocytopenic purpura. - Sever cardiac, respiratory, renal or hepatic impairment. - Presence of communication barrier 8 Year(s) 18 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 11/03/2017 institutional review board, faculty of medicine, Mansora university
Ethics Committee Address
Street address City Postal code Country
faculty of medicine, Bilding A, first floor Mansoura 002050 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Fromme¿s field visibility scale assessed by the surgeon during: Superficial dissection, muscular dissection, implant application and osteotomy.
Primary Outcome Total Morphine consumption during first 24h postoperatively
Secondary Outcome Estimated blood loss. intraoperative
Secondary Outcome Dissection time starting from skin incision tell complete bilateral muscular separation from the spines.
Secondary Outcome The Number of blood transfusion unites intra and postoperatively
Secondary Outcome utilization of nitroglycerine, propranolol, fentanyl and atracurium other than induction doses Intraoperative
Secondary Outcome MBP and HR basal, just after infiltration, incision, during superficial dissection, muscular dissection, every 30 minutes during implant application, osteotomy and spinal correction, then every 6 hours postoperatively.
Secondary Outcome The number of hypo and hypertensive episodes intraoperative.
Secondary Outcome The amount of fluid utilization. intraoperative
Secondary Outcome isoflurane concentration every 30 min intraoperatively.
Secondary Outcome VAS. every 4 h during first 24 hours
Secondary Outcome the incidence of Bupivacaine and epinephrine side effects intraoperative
Secondary Outcome Time of successful ambulation, after operation.
Secondary Outcome Hospital stay, postoperative
Secondary Outcome Incidence of wound complications: infection, dehiscence, seroma, hematoma, bleeding. postoperative for 2 weeks
Secondary Outcome Surgeon satisfaction with surgical field at the end of operation in a score of 0-10. just after the operation
Secondary Outcome Patient satisfaction with analgesia by a score from 0-10. after 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university hospital al gomhourya sreet Mansoura 002050 Egypt
Delta Hospital gehan street, in front of Emergency Hospital Mansoura 002050 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura University Hospital al gomhourya sreet Mansoura 002050 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine, Mansoura universisty al gomhourya sreet Mansoura 002050 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Serry faculty of medicine Mansoura 002050 Egypt
Mohamed Kassem faculty of medicine Mansoura 002050 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alaa Mazy alaa_mazy@yahoo.com 002 01140065052 faculty of medicine
City Postal code Country Position/Affiliation
Mansoura 002050 Egypt associate profesor of anestheia and surgical intensive care
Role Name Email Phone Street address
Public Enquiries Alaa Mazy alaa_mazy@yahoo.com 002 01140065052 faculty of medicine
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 faculty of medicine
City Postal code Country Position/Affiliation
Mansoura 002050 Egypt associate profesor of anestheia and surgical intensive care
REPORTING
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