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.: PACTR202308663873345 Date of Approval: 07/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Bupivacaine vs Bupivacaine and dexmedetomidine for caudal epidural blocks as an adjuvant to general anesthesia in lumbosacral surgeries.
Official scientific title Bupivacaine vs Bupivacaine and dexmedetomidine for caudal epidural blocks as an adjuvant to general anesthesia in lumbosacral surgeries.
Brief summary describing the background and objectives of the trial Acute pain after spine surgery is usually controlled by intravenous opioids. Utilizing a combination of different analgesic modalities achieving better pain relief, sparing opioids and decreasing their adverse effects. A caudal epidural block can be incorporated as a part of multimodal analgesia for lumbosacral spine surgeries. It is a simple and safe technique that can be easily performed under fluoroscopy in prone position. The injection site is far away from the operative site, which decreases the risk of CSF leakage or infection). However, the analgesic effect of a single-shot caudal block can last only for short time even with long-acting local anesthetics. Adding non-opioid adjuvants like alpha-2 agonists (dexmedetomidine) improves both the quality and duration of analgesia. Dexmedetomidine is a sympatholytic selective Alpha-2 agonist. Alpha-2 receptors are found in postsynaptic dorsal horn neurons. Activation of these receptors has an analgesic effect mediated by depressing neurotransmitters of C fibers. Dexmedetomidine with a safe pharmacokinetic profile is a good neuraxial adjuvant. The objectives are to assess the effect of adding dexmedetomidine perineurally to bupivacaine in caudal epidural block for postoperative analgesia following lumbosacral surgeries under general anesthesia regarding; duration of postoperative analgesia as a primary objective and one-day postoperative opioid consumption as a secondary objective.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Nervous System Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/04/2023
Actual trial start date 01/04/2023
Anticipated date of last follow up 30/09/2023
Actual Last follow-up date 30/09/2023
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Bupivacaine for combined caudal epidural blocks with general anesthesia in lumbosacral surgeries Isobaric Bupivacaine (0.25%) 20 ml + 0.5 ml normal saline Caudal block is done within 20 minutes then assessment is done over 24 hours postoperatively. Induction of general anesthesia will be performed then after securing the airway, patient stabilization and proper positioning in the prone position, the caudal epidural block is performed. 30 Active-Treatment of Control Group
Experimental Group Bupivacaine and dexmedetomidine for caudal epidural blocks with GA in lumbosacral surgeries. 20 ml plain bupivacaine (0.25%) + 2.5μg/ml dexmedetomidine (50 μg = 0.5 ml) Block is done in 20 minutes then assessment is done for 24 hours postoperatively. Induction of general anesthesia will be performed then after securing the airway, patient stabilization and proper positioning in the prone position, the caudal epidural block is performed. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age 18-60 years. 2. Sex: Both sexes. 3. American Society of Anesthesiologists (ASA) Physical Status Class-I and II. 4. Scheduled for lumbosacral surgery with instrumental fixation under General Anesthesia 1. Declining to give written informed consent or preoperative neurological defects as sensory or motor dysfunction that hinders informed consent. 2. History of allergy to the medications used in the study. 3. Contraindications to regional anesthesia (including coagulopathy and local infection). 4. Drug abusers either opioids or NSAIDs. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 28/03/2023 FMASU REC
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine, Ain Shams University, Abbasia, Cairo, Egypt Cairo 11311 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Duration of postoperative analgesia. 24 hours
Secondary Outcome One-day postoperative opioid consumption. 24 hours.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospitals. Ain Shams University Hospitals, Al-Abbasia, Cairo, Egypt. Cairo 11311 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Eldemerdash Hospitals Abbasia, Cairo, Egypt Cairo 0000 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Eldemerdash Hospitals Abbasia, Cairo, Egypt Cairo 11311 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Salma Ayman ahsnyso-1995@hotmail.com +201285665828 84B Gesr Elsues, Cairo, Egypt
City Postal code Country Position/Affiliation
Cairo 11311 Egypt Anesthesia Resident
Role Name Email Phone Street address
Public Enquiries Mostafa Mansour mostafa.mansour@med.asu.edu.eg +201093322145 Cairo
City Postal code Country Position/Affiliation
Cairo 0000 Egypt Assistant Professor of Anesthesia
Role Name Email Phone Street address
Scientific Enquiries Amr Abd El Fatah dramr2001@gmail.com +2010001034225 Cairo
City Postal code Country Position/Affiliation
Cairo 0000 Egypt Professor of Anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification. (including text, tables, figures, and appendices). Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication. No end date. Anyone who wishes to access the data. For any type of analyses. The data will be available in our university's data warehouse.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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