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.: PACTR202310515862483 Date of Approval: 18/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title comparison of adding dexmedetomidine versus fentanyl to Intrathecal local anesthetic aiming at prevention or lowering the incidence of rebound pain in patients undergoing open surgeries under spinal anesthesia. a Randomized Controlled Trial.
Official scientific title Dexmedetomidine Versus Fentanyl Added to Intrathecal Local Anesthetic for Prevention of Rebound Pain in Patients Undergoing Open Surgeries Under Spinal Anesthesia.
Brief summary describing the background and objectives of the trial Spinal anesthesia is a safe and reliable method of anesthesia for abdominal and lower limb surgery, with the advantages of rapid onset of action, economical and easy to administer, and a relatively low side effects rate and shorter post-anesthesia care unit stay. Regional anesthesia (RA) techniques have been shown to reduce perioperative opioid requirements, postoperative length of stay, and positively impact long-term outcomes such as the risk of persistent postsurgical pain (PPSP), morbidity, and mortality. It has been found that many drugs, such as opioids α2 adrenergic agonists can be used as adjuvants for intrathecal local anesthetics to improve the quality of spinal anesthesia. Rebound pain is a recently introduced term used to describe acute postoperative pain occurring after regression of the sensory block associated with regional anesthesia. It has been observed to occur after both peripheral nerve block and neuraxial anesthesia. Essential characteristics of rebound pain are that it is acute postoperative pain, ensues following resolution of PNB or neuraxial block, and is clinically significant, either with regard to the intensity of pain or the impact on psychological well-being, quality of recovery, and activities of daily living. This study aims to assess the efficacy of addition of dexmedetomidine versus fentanyl to the local anesthetic for prevention of rebound pain after open surgeries performed under spinal anesthesia. We hypothesize that the intrathecal dexmedetomidine administration would decrease the incidence of rebound pain. Incidence of intraoperative hypotension, bradycardia, nausea, vomiting and pruritus compared between fentanyl and dexmedetomidine groups. Severity of rebound pain score (RPS), duration of the sensory and motor blocks, deepest level of sedation, patient satisfaction from pain control and meperidine requirement all compared between two groups.
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 Rehabilitation
Anticipated trial start date 01/06/2022
Actual trial start date 01/09/2022
Anticipated date of last follow up 01/06/2023
Actual Last follow-up date 01/09/2023
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group spinal anesthesia with dexmedetomidine as adjuvant 5 microgram dexmedetomidine added to 15 mg bupivacaine after induction After decontaminating the patient’s skin with a chlorhexidine-in-alcohol solution, conventional palpation technique will be used. The midline will be identified by palpation of the tip of spinous processes and the line connecting the iliac crests (Tuffier`s line) will be assumed to cross the L4-L5 interspace. L2-L3 interspace is identified and a midline approach will be typically used. The puncture site will be infiltrated with lidocaine and a 25-gauge Quincke spinal needle will be introduced to the subarachnoid space. After obtaining free flow of cerebrospinal fluid (CSF), hyperbaric bupivacaine 15 mg will be administered intrathecally. According to random assignment, patients in dexmedetomidine group will receive intrathecal injection of 5 microgram dexmedetomidine. A prefilled 1ml syringe will be prepared by a separate nurse anesthesiologist not participating in the study who will hand it over to the anesthesiologist who will conduct the spinal anesthesia procedure. This syringe will contain an equal volume of either dexmedetomidine or fentanyl diluted to 0.5 mL. After completing the spinal anesthesia, patients will be placed in supine position and a solution of ringer acetate will be infused intravenously at a rate of 10 mL/kg. The upper sensory level will be assessed using pin prick and the motor block level will be assessed by Bromage score (I, unable to move feet or knee; II, able to move feet only; III, just able to move knees; IV, full flexion of knees and feet). Surgery will start after attaining a sensory level of T6 or higher and the type and duration of the surgery will be recorded. The level after 10 minutes of intrathecal injection will be recorded; a level below T6 will be considered a failed spinal block and the patient will be excluded from the study and managed as appropriate. 60
Control Group spinal anesthesia with fentanyl as adjuvant 20 microgram fentanyl added to 15 mg bupivacaine after induction After decontaminating the patient’s skin with a chlorhexidine-in-alcohol solution, conventional palpation technique will be used. The midline will be identified by palpation of the tip of spinous processes and the line connecting the iliac crests (Tuffier`s line) will be assumed to cross the L4-L5 interspace. L2-L3 interspace is identified and a midline approach will be typically used. The puncture site will be infiltrated with lidocaine and a 25-gauge Quincke spinal needle will be introduced to the subarachnoid space. After obtaining free flow of cerebrospinal fluid (CSF), hyperbaric bupivacaine 15 mg will be administered intrathecally. According to random assignment, patients in fentanyl group will receive intrathecal injection of 20 microgram fentanyl. A prefilled 1ml syringe will be prepared by a separate nurse anesthesiologist not participating in the study who will hand it over to the anesthesiologist who will conduct the spinal anesthesia procedure. This syringe will contain an equal volume of either dexmedetomidine or fentanyl diluted to 0.5 mL. After completing the spinal anesthesia, patients will be placed in supine position and a solution of ringer acetate will be infused intravenously at a rate of 10 mL/kg. The upper sensory level will be assessed using pin prick and the motor block level will be assessed by Bromage score (I, unable to move feet or knee; II, able to move feet only; III, just able to move knees; IV, full flexion of knees and feet). Surgery will start after attaining a sensory level of T6 or higher and the type and duration of the surgery will be recorded. The level after 10 minutes of intrathecal injection will be recorded; a level below T6 will be considered a failed spinal block and the patient will be excluded from the study and managed as appropriate. 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients undergoing open surgeries under spinal anesthesia of both genders. American Society of Anesthesiologists physical status I and II patients. Age < 18 years. Contraindications to neuraxial anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection). Hypersensitivity to any of the administered drugs. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 85 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 15/08/2022 Institutional Research Board
Ethics Committee Address
Street address City Postal code Country
nstitutional research board office- building A - ground floor- faculty of medicine Mansoura university Mansoura Mansoura 35511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence of rebound pain after wearing off of the spinal anesthesia. after 24 hours
Secondary Outcome Incidence of intraoperative hypotension and bradycardia. Severity of rebound pain score (RPS) Duration of the sensory block. Duration of the motor block. The deepest level of sedation at 2, 4, 6, 12, 24 hours (h) postoperatively. Patient satisfaction from pain control. Time to first intravenous (IV) meperidine requirement. Cumulative consumption of IV meperidine at 2, 4, 6, 12, 24 hours (h) postoperatively. Incidence of side effects (nausea and vomiting and pruritus). after 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Hospitals El Goumhoria st Mansoura 35511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Moaaz Mohammed Mohammed ElSaeed Abdou Maarof Mansoura 35511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University Hospitals El Goumhoria st Mansoura 35511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Moaaz Mohammed Mohammed ElSaeed Abdou Maarof Mansoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moaaz ElSaeed moaaz.mohammed94@gmail.com +201018020909 Abdou Maarof
City Postal code Country Position/Affiliation
Mansoura Egypt Resident of anesthesia faculty of medicine Mansoura University Hospitals
Role Name Email Phone Street address
Public Enquiries Nabil Abdelraouf nabilabdelraouf60@mans.edu.eg +201142507020 Qanat ElSwes
City Postal code Country Position/Affiliation
MAnsoura Egypt Professor of Anesthesia faculty of Medicine mansoura university hospitals
Role Name Email Phone Street address
Scientific Enquiries Samah ElKenany drsamah2008@mans.edu.eg +201002262557 EL Goumhoria st
City Postal code Country Position/Affiliation
Mansoura Egypt assistant professor of anesthesia at Mansoura University Hospitals
Role Name Email Phone Street address
Scientific Enquiries May ElSherbiny Mayelsherbiny@mans.edu.eg +201007193959 El Goumhoria st
City Postal code Country Position/Affiliation
Mansoura Egypt Lecturer of anesthesia at Mansoura University Hospitals
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results, after deidentification (text ,tables, figures, and appendices) will be reported. We will individual participate data and share it through the PubMed indexed journal. IPD that will be generated from this study will be shared upon request from the researchers and permission from the University research and publication director Informed Consent Form 1 year We will provide individual participant data and share it through the PubMed indexed journal
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