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.: PACTR202311772437904 Date of Approval: 06/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A Comparison Between Ultrasound Guided Erector Spinae Block Using Bupivacaine versus Bupivacaine & Dexmedetomidine for Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy: A Randomized Controlled Double-Blinded Study
Official scientific title A Comparison Between Ultrasound Guided Erector Spinae Block Using Bupivacaine versus Bupivacaine & Dexmedetomidine for Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy: A Randomized Controlled Double-Blinded Study
Brief summary describing the background and objectives of the trial Percutaneous nephrolithotomy (PCNL) is a popular and effective treatment for large kidney stones. The Erector Spinae block (ESB) is a regional anesthetic technique that can provide pain relief for patients undergoing PCNL. Adding the drug dexmedetomidine to the local anesthetic used in ESB can extend the duration of sensory and motor block and reduce postoperative pain. This study aimed to assess the safety and efficacy of adding dexmedetomidine as an adjuvant to the local anesthetic used in ESB in patients scheduled for PCNL. Fifty patients were randomly divided into two groups (25 each). Group A received the local anesthetic bupivacaine alone, while Group B received bupivacaine plus dexmedetomidine. The researchers recorded the postoperative 24-hour morphine consumption, intraoperative fentanyl consumption, intraoperative hemodynamics, and side effects as nausea, vomiting, bleeding, or organ injury.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2021
Actual trial start date 01/01/2021
Anticipated date of last follow up 30/06/2021
Actual Last follow-up date 30/06/2021
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
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 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 Bupivacaine alone 30 mL of bupivacaine 0.25% The performance of the block requires about 5 minutes. It is performed 10 minutes before starting the surgery. Under complete Aseptic technique which was done by wearing sterile gown and sterile gloves, then the skin was sterilized using chlorhexidine. The location of the eighth rib was found using a counting down approach from the first rib under ultrasonography {Mindray, Model: DC-N2} and marked on the skin. After placing a 5–12 MHz linear probe parallel to the vertebral axis at the level of the 10th rib, the probe was moved from the lateral side to medial side transversely to identify any change in shape that transited the rib and transverse process (TP). When the round shadow of the rib was shifted into the rectangular shape of the TP, an 18-gauge Tuohy needle (Perifix, B. Braun Melsungen AG, Melsungen, Germany) was inserted toward the trapezius and Erector Spinae and the TP of T10 using the plane technique in a cephalad-to-caudal direction. When the needle was in contact with the TP, we confirmed that this fascial plane is well separated by injecting 2 ml of saline. Then, we injected our medications according to the group. In the control group, a total of 30 mL of bupivacaine 0.25% was injected. 25 Active-Treatment of Control Group
Experimental Group Bupivacaine and dexmedetomidine The performance of the block requires about 5 minutes. It is performed 10 minutes before starting the surgery. Under complete Aseptic technique which was done by wearing sterile gown and sterile gloves, then the skin was sterilized using chlorhexidine. The location of the eighth rib was found using a counting down approach from the first rib under ultrasonography {Mindray, Model: DC-N2} and marked on the skin. After placing a 5–12 MHz linear probe parallel to the vertebral axis at the level of the 10th rib, the probe was moved from the lateral side to medial side transversely to identify any change in shape that transited the rib and transverse process (TP). When the round shadow of the rib was shifted into the rectangular shape of the TP, an 18-gauge Tuohy needle (Perifix, B. Braun Melsungen AG, Melsungen, Germany) was inserted toward the trapezius and Erector Spinae and the TP of T10 using the plane technique in a cephalad-to-caudal direction. When the needle was in contact with the TP, we confirmed that this fascial plane is well separated by injecting 2 ml of saline. Then, we injected our medications according to the group. In the experimental group, a total of 30 mL of bupivacaine 0.25% plus 2 ml of dexmedetomidine (0.5 μg/kg) were injected. 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged between 21 and 70 years Patients scheduled for PCNL ASA classification I or II Ability to sign the consent Patient refusal Coagulation disorders (INR >1.4 or platelets < 80000) Skin lesion or infection at the site of injection or puncture Known allergy to local anesthetics or any of the study medications Patients suffering from neurological or mental disease ASA III or IV Conversion to open surgery Opioid consumption 48 hours before the operation Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 70 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 10/11/2020 Research Ethics Committee Faculty of Medicine Cairo University
Ethics Committee Address
Street address City Postal code Country
Kasr Alainy street Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The total morphine consumption Within 24 hours postoperatively
Secondary Outcome Hemodynamics (the mean arterial blood pressure and heart rate) Before induction of general Anesthesia, before starting the block, and 30 minutes after performing the block.
Secondary Outcome Total fentanyl consumption During the operation
Secondary Outcome Complications e.g. nausea, vomiting, bleeding, or organ damage. After the operation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Souad Kafafi University Hospital 26th of July Corridor 6th of October Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Manar Mahmoud ElKholy Kasr Alainy Street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Souad Kafafi University Hospital 26th of July Corridor 6th of October Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Manar ElKholy Manar.elkholy@must.edu.eg 000000000000000 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
Role Name Email Phone Street address
Scientific Enquiries Yahya Hammad res.train.1111@gmail.com +201114048081 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
Role Name Email Phone Street address
Public Enquiries Yahya Hammad res.train.1111@gmail.com +201114048081 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share the individual de-identified participants’ data. The datasets generated during and/or analyzed during the current study will be available from the corresponding author on reasonable request, beginning 12 months and ending 24 months following article publication. Study Protocol From 12 to 24 months after article publication The data will be available on reasonable request to the corresponding author, to be used for systematic reviews or meta-analyses.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 02/11/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 02/11/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information