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.: PACTR201606001657480 Date of Approval: 31/05/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Hypobaric Rather Than Isobaric Bupivacaine to Prevent Anesthesia-induced Hypotension in Patients Undergoing Surgical Repair of Hip Fracture Under Cont
Official scientific title A prospective randomized controlled study to compare the incidence of per-operative hypotension in elderly patients undergoing surgical repair of hip fracture under continuous spinal anesthesia with isobaric versus hypobaric bupivacaine
Brief summary describing the background and objectives of the trial Anesthesia for surgical repair of hip fracture is still controversial. Large retrospective studies and systematic reviews failed to demonstrate the superiority of either general or regional anesthesia. However, continuous spinal anesthesia has been shown to preserve hemodynamics better than general and single shoot spinal anesthesia. Nevertheless, hypotension still occurs with continuous spinal anesthesia. Unilateral spinal anesthesia may be achieved by hypobaric bupivacaine when patients are in the lateral position. Unilateral spinal anesthesia is more effective in preserving hemodynamics by limiting the spread of the sympathetic blockade to the operated side. Our goal is to show that the use of hypobaric rather than isobaric bupivacaine in continuous spinal anesthesia for surgical repair of hip fracture reduces incidence of hypotension. Half of the patients will receive hypobaric bupivacaine and the over half will reveive isobaric bupivacaine and hemodynamic data will be compared.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/03/2016
Actual trial start date 15/03/2016
Anticipated date of last follow up 31/12/2016
Actual Last follow-up date 01/03/2017
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
NCT02428257 clinicaltrials.gov
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 Simple randomisation using a radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Isobaric bupivacaine Initial boluses of 2.5 mg until sensory blockade reached T12. Per-operatively, additional 1 mg boluses according to patient analgesic demand During the surgery (maximal duration of 2 hours) Continuous spinal anesthesia: Spinal puncture performed with a 19-gauge Tuohy needle at the L4-L5 or L3-L4 interspace using a midline approach. 3 cm of a 22-gauge catheter introduced through the needle, directed to the fractured side. Local anesthetic used: 0.5% isobaric bupivacaine. 60 Active-Treatment of Control Group
Experimental Group Hypobaric bupivacaine Initial boluses of 2.5 mg until sensory blockade reached T12. Per-operatively, additional 1 mg boluses according to patient analgesic demand During the surgery (maximal duration of 2 hours) Continuous spinal anesthesia: Spinal puncture performed with a 19-gauge Tuohy needle at the L4-L5 or L3-L4 interspace using a midline approach. 3 cm of a 22-gauge catheter introduced through the needle, directed to the fractured side. Local anesthetic used: hypobaric bupivacaine, prepared diluting each 1 ml of 0.5% isobaric bupivacaine with 1 ml of sterile water. 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged more than 65 years. Scheduled for a surgical repair of a hip fracture. Contraindication to spinal anesthesia or peripheral nerve blocks including hemostasis anomalies, local infection, allergic reaction to local anesthetics. Dementia. Consent refusal. 65 Year(s) 120 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 15/12/2015 CE-IMKO
Ethics Committee Address
Street address City Postal code Country
Avenue Habib Bourguiba Ksar Said 2010 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The percentage of patients who experienced at least one episode of hypotension during surgery (fall of more than 20% of systolic blood pressure) among the 2 groups End of surgery (2 hours)
Secondary Outcome Total bupivacaine consumption: total dose of bupivacaine needed to perform the surgery End of surgery (2 hours)
Secondary Outcome vasopressor use: total ephedrine injected if hypotension occurred End of surgery (2 hours)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Institut Mohamed Kassab d'Orthopédie Avenue Habib Bourguiba Ksar Said 2010 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Institut Mohamed Kassab d'Orthopédie Avenue Habib Bourguiba Ksar Said 2010 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Institut Mohamed Kassab d'Orthopédie Avenue Habib Bourguiba Ksar Said 2010 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Olfa Kaabachi Avenue Habib Bourguiba Ksar Said 2010 Tunisia
Abderrahmen Bargaoui Avenue Habib Bourguiba Ksar Said 2010 Tunisia
Olfa Kaabachi Avenue Habib Bourguiba Ksar Said 2010 Tunisia
Abderrahmen Bargaoui Avenue Habib Bourguiba Ksar Said 2010 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Olfa Kaabachi Olfa.kaabachi@gnet.tn 0021698317381 Avenue Habib Bourguiba
City Postal code Country Position/Affiliation
Ksar Said 2010 Tunisia Department of anesthesia and critical care
Role Name Email Phone Street address
Public Enquiries Olfa Kaabachi olfa.kaabachi@gnet.tn 0021698317381 Avenue Habib Bourguiba
City Postal code Country Position/Affiliation
Ksar Said 2010 Tunisia Department of anesthesia and critical care
Role Name Email Phone Street address
Scientific Enquiries Abderrahmen Bargaoui bargaoui.abd@gmail.com 0033755846993 Avenue Habib Bourguiba
City Postal code Country Position/Affiliation
Ksar Said 2010 Tunisia Department of Anesthesia and Critical Care
REPORTING
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