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.: PACTR201611001737111 Date of Approval: 07/08/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Dexmedetomidine versus Fentanyl as adjuvants to local anesthetic mixture in peribulbar block for retinal surgery, a randomized prospective study.
Official scientific title Dexmedetomidine versus Fentanyl as adjuvants to local anesthetic mixture in peribulbar block for retinal surgery, a randomized prospective study.
Brief summary describing the background and objectives of the trial Different anesthetic techniques (general, topical, or regional anaethesia) may be used for ophthalmic surgeries. Regional block is the preferred choice of anesthesia for many ophthalmic surgeons because it is more economic, easy to be performed, and associated with less complications, better postoperative analgesia and early discharge of the patient compared to GA. Retinal surgery presents a multitude of problems to the anesthesiologists. Most of the patients are old age , this makes regional block advisable to decrease risks and morbidity. Peribulbar anaethesia has been the anesthesia of choice for ophthalmic surgery because it has less complications (3, 4) Peribulbar block with local anesthetics only lead to delayed onset of globe akinesia, frequent need of block supplementation due to short duration of analgesia, and late onset of corneal anesthesia. Many drugs (5) such as clonidine(6), sodium bicarbonate, Vecuronium, Rocuronium(5) Atracurium(7) hyluronidase (8)and adrenaline were added to local anesthetics to improve the quality of the block but with limited success Fentanyl is an opioid that can be given intrathecal, epidural, and added to local anesthetics for peripheral nerve block to decrease the onset time of analgesia and prolonged the duration of the block.(9) Dexmetedomidine is an alpha 2 adrenergic receptor agonist with haemodynamic- stabilizing properties, sedative, analgesic, and sympatholytic effects. Adding dexemedetomidine to local anesthetics during regional anesthesia and peripheral nerve blockade is proved to be efficacious for the surgical patient. (10) The aim of this study to evaluate and compare the effects of adding dexmedetomidine versus fentanyl as adjuvants to Lidocaine2%, Bupivacaine 0.5%and hyluronida
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Eye Diseases,local anesthetic mixture in peribulbar block for retinal surgery,,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/07/2016
Actual trial start date 02/07/2016
Anticipated date of last follow up 02/01/2017
Actual Last follow-up date 02/01/2017
Anticipated target sample size (number of participants) 128
Actual target sample size (number of participants) 130
Recruitment status Recruiting
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomisation (please state block size and whether or not the block size was variable) Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group GROUP F Receiving 4 cc Bupivacaine 0.5% + 4cc lidocaine 2% pluse hyluronidase 15 IU/mL + 1cc contianing 20 microgram of fentanyl local anesthetic mixture will be injected using 25-gauge, 5/8 inch needle in the area limited laterally by imaginary perpendicular line joining inferior lacrimal papilla to the inferior margin of the orbit and superiorly by the inferior lacrimal canaliculus, medially by the lateral margin of the nose, and inferiorly by the inferior margin of the orbit 65
Experimental Group GROUP D Receiving 4 cc Bupivacaine 0.5% + 4cc lidocaine 2% pluse hyluronidase 15 IU/mL + 1cc contianing 20 microgram of dexmedetomidine. local anesthetic mixture will be injected using 25-gauge, 5/8 inch needle in the area limited laterally by imaginary perpendicular line joining inferior lacrimal papilla to the inferior margin of the orbit and superiorly by the inferior lacrimal canaliculus, medially by the lateral margin of the nose, and inferiorly by the inferior margin of the orbit 65
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
, ASA I-III, aged 40-80 years old, scheduled for retinal surgery under local anesthesia will be included in the study 1. Patients age below 40 years and above 80 years. 2. Patients with active ocular infection. 3. Single eyed patients. 4. Patient refuses local anesthetics. 5. Patients known to be allergic to bupivacaine and lidocaine. 6. Patients can not lie flat. 7. Coagulopathy. 40 Year(s) 80 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 22/06/2016 research ethics committee, tanta university , faculty of medicine
Ethics Committee Address
Street address City Postal code Country
faculty of medicine , albar street tanta Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ¿ Effectiveness of the block every 2 minutes for maximum of 10 minutes
Primary Outcome sensory block every minute for maximum of 10 minutes
Primary Outcome The duration of sensory block and the duration of motor block by frequent examination in the postoperative period every 15 minutes till complet recovery of sensory and motor function .
Primary Outcome ¿ Effectiveness of the block every 2 minutes for maximum of 10 minutes
Primary Outcome sensory block every minute for maximum of 10 minutes
Primary Outcome The duration of sensory block and the duration of motor block by frequent examination in the postoperative period every 15 minutes till complet recovery of sensory and motor function .
Secondary Outcome ¿ Sedation levels will be assessed by Ramsay Sedation Score Every 15 min for 2 hours after injection of local anesthetics then every 30 min for another 2 hours
Primary Outcome ¿ Effectiveness of the block every 2 minutes for maximum of 10 minutes
Primary Outcome sensory block every minute for maximum of 10 minutes
Primary Outcome The duration of sensory block and the duration of motor block by frequent examination in the postoperative period every 15 minutes till complet recovery of sensory and motor function .
Secondary Outcome ¿ Sedation levels will be assessed by Ramsay Sedation Score Every 15 min for 2 hours after injection of local anesthetics then every 30 min for another 2 hours
Secondary Outcome ¿ Heart rate, mean arterial blood pressure and sp02 will be recorded at 5 mins interval for the first 20mins, thereafter every 15mins till 1hr and every hour for next 5hrs
Secondary Outcome ¿ Visual analogue scale will be used to assess the patients¿ level of pain at 1, 2, 4, 6, 8, 12, and 24 h postoperatively
Secondary Outcome The total paracetamol consumption (mg) and the number of patients (%) requiring naluphin as rescue analgesia medication, the time of first request for analgesic will be recorded. 24 hours postoperatively
Primary Outcome ¿ Effectiveness of the block every 2 minutes for maximum of 10 minutes
Primary Outcome sensory block every minute for maximum of 10 minutes
Primary Outcome The duration of sensory block and the duration of motor block by frequent examination in the postoperative period every 15 minutes till complet recovery of sensory and motor function .
Secondary Outcome ¿ Sedation levels will be assessed by Ramsay Sedation Score Every 15 min for 2 hours after injection of local anesthetics then every 30 min for another 2 hours
Secondary Outcome ¿ Heart rate, mean arterial blood pressure and sp02 will be recorded at 5 mins interval for the first 20mins, thereafter every 15mins till 1hr and every hour for next 5hrs
Secondary Outcome ¿ Visual analogue scale will be used to assess the patients¿ level of pain at 1, 2, 4, 6, 8, 12, and 24 h postoperatively
Secondary Outcome The total paracetamol consumption (mg) and the number of patients (%) requiring naluphin as rescue analgesia medication, the time of first request for analgesic will be recorded. 24 hours postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta university hospital al bahr street tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
tanta univerity hospital al bahr street tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor tanta university faculty of medicine albahr street tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
hesham mohamed marouf hasan radwn street tanta Egypt
Naglaa khalil yousef hasan radwan street tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hesham marouf heshammarouf@hotmail.com 00201274366808 Hasan Radwan street ( at its crossing with Said Kotb street ) Safier 1 tower, Tanta , Egypt.
City Postal code Country Position/Affiliation
tanta Egypt
Role Name Email Phone Street address
Principal Investigator naglaa khalil heshammarouf@hotmail.com 00201273547762 hasan radwan street
City Postal code Country Position/Affiliation
tanta Egypt
Role Name Email Phone Street address
Public Enquiries hesham marouf heshammarouf@hotmail.com 00201274366808 hasan radwan street
City Postal code Country Position/Affiliation
tanta Egypt
Role Name Email Phone Street address
Scientific Enquiries hesham marouf heshammarouf@hotmail.com 00201274366808 hasan radwan street
City Postal code Country Position/Affiliation
tanta Egypt
REPORTING
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