Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: www.pactr.org
Trial no.: PACTR201708002496243 Date registered: 03/08/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Fentanyl versus Midazolam as additive to Local Anesthetic Mixture for Peribulbar Block during Posterior Segment Surgery in Adult Patients
Official scientific title Fentanyl versus Midazolam as additive to Local Anesthetic Mixture for Peribulbar Block during Posterior Segment Surgery in Adult Patients
Brief summary describing the background and objectives of the trial Abstract Objectives: To evaluate the analgesic and hemodynamic outcome of fentanyl or midazolam versus a control group for peribulbar block (PBB) during posterior chamber surgery. Patients & Methods: 132 patients were grouped into Group C received LAM plus 1 ml plain saline, Group F received LAM plus 25 ¿g fentanyl in 1 ml saline and Group M received LAM plus 1 mg midazolam in 1 ml saline. Study outcomes included evaluation and scoring of eyelid and globe akinesia, total 15-min akinesia score and duration of block. Intraoperative hemodynamic measures were assessed every 15 minutes during the entire procedure and every 30 minutes during the first two postoperative (PO) hours.. PO analgesia was hourly-assessed using Visual Analogue Score (VAS) and rescue analgesia was provided at VAS of >5. Results: Frequency of patients had fast eyelid and globe akinesia was significantly higher with significantly lower total 15-min score in group F than other groups. Intraoperative and PO hemodynamic measures were non-significantly different between studied groups. Duration of block was significantly longer in groups F and M than group C with significantly longer duration in group F. The number of patients who required PO rescue analgesia was significantly less in group F (p<0.05) than in the other 2 groups¿. Conclusion: The addition of Fentanyl (25 ¿g) or Midazolam (1 mg) to LAM (1.8 ml of mepivacaine 3%, 1 ml of hyaluronidase containing 150 IU, 3 ml of bupivacaine 0.5%, 1 ml of lidocaine 2%.) for PBB during posterior chamber surgery in adult patients provided satisfactory anesthetic outcome than LAM alone. Fentanyl was superior to midazolam in terms of significantly faster onset, longer block duration with significantly longer PO analgesia and lesser consumption of rescue analgesia. There were no significant differences in intra-operative and PO hemodynamic measures between the 3 groups.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Randomization
Disease(s) or condition(s) being studied Anaesthesia,Eye Block,Eye Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 03/01/2017
Actual trial start date 17/01/2017
Anticipated date of last follow up 03/05/2017
Actual Last follow-up date 13/08/2017
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 132
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program 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 Eye Block Fentanyl Group Group F received LAM plus 25 ¿g fentanyl in 1 ml saline 4.75 hours booster dose 44 Active-Treatment of Control Group
Control Group Eye Block Control Group Group C received Local Anesthetic Mixture plus 1 ml plain saline 3 hours booster dose 44 Active-Treatment of Control Group
Experimental Group Eye Block Midazolam Group and Group M received LAM plus 1 mg midazolam in 1 ml saline. 4.5 hours booster dose 44 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients were clinically evaluated for fitness for anesthesia and categorized according to ASA l grade and patients who had co-morbidities underwent preoperative contro and continued on their treatment during postoperative (PO) course. 1-Patients with impaired orbital/periorbital sensation, 2-Patients had history of bleeding tendency 3-Patients on current anticoagulants or antiplatelets 4-Patients had allergy to local anesthetics, 5-Patients had posterior staphyloma or with axial length >30 mm were excluded from the study. 44 Year(s) 69 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
No 01/05/2016 Fentanyl versus Midazolam as additive to Local Anesthetic Mixture for Peribulbar Block during Posterior Segment Surgery in Adult Patients
Ethics Committee Address
Street address City Postal code Country
Kasr Alainy Cairo 55555 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Motor block was evaluated using a three point scoring (14). The onset of eyelid and globe akinesia was assessed at 1, 3, 5, 10 and 15 minute and then every 15 minutes after surgery until complete recovery of the block. Duration of block was calculated starting from 15-min after LAM injection till complete recovery. Eye Block for at least 3 hours
Secondary Outcome 2. Hemodynamic variables were assessed every 15 minutes during the entire procedure and every 30 minutes during the first two postoperative (PO) hours. Hypotension and bradycardia were defined as a 20% decrease in MAP and HR in relation to baseline measures. Eye Block for at least 3 hours
Secondary Outcome 3. PO analgesia was assessed by using 11-points Visual Analogue Score (VAS) every hour for 6-hrs PO and was scored as 0 if no pain up to 10 which indicates intolerable pain sensation. PO analgesia was provided as if VAS was >5 in the form of intramuscular injection of diclofenac 75 mg. Eye Block for at least 3 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kasr Al Ainy Hospitals-Cairo University Kasr Al Ainy Street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Kasr Al Ainy Hospitals-Cairo University Kasr Al Ainy Street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Authors Kasr Al AinyHospitals Cairo 55555 Egypt Commercial Sector/Industry
Secondary Sponsor Kasr Al Ainy Hospitals-Cairo University Kasr Al Ainy Street Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Abdalla AL Ahram Giza 55555 Egypt
Tamer Safan Dokki Giza Egypt
Tamer Khair Zaiton Cairo Egypt
Ahmed Shaker Dokki Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Abdalla ahmed.aboali7268@gmail.com 00201272222923 AL Ahram
City Postal code Country Position/Affiliation
Cairo 55555 Egypt Assistant Professor of Anesthesia
Role Name Email Phone Street address
Principal Investigator Tamer Safan safan.tamer@hotmail.com 0020123337850 Dokki
City Postal code Country Position/Affiliation
Giza Egypt Lecurer of Anesthesia
Role Name Email Phone Street address
Principal Investigator Tamer Khair tamerkhair73@gmail.com 00201223889544 Zaiton
City Postal code Country Position/Affiliation
Cairo Egypt Lecurer of Anesthesia
Role Name Email Phone Street address
Public Enquiries Ahmed Shaker asragab1@yahoo.com 00201003252323 EL Shek Zayed
City Postal code Country Position/Affiliation
Giza 55555 Egypt Lecturer of Anesthesia
Role Name Email Phone Street address
Scientific Enquiries Ahmed Shaker asragab1@yahoo.com 00201003252323 Dokki
City Postal code Country Position/Affiliation
Giza 55555 Egypt Lecurer of Anesthesia
Role Name Email Phone Street address
Scientific Enquiries Tamer Khair tamerkhair73@gmail.com 00201223889544 Zaiton
City Postal code Country Position/Affiliation
Cairo 55555 Egypt Lecturer of Anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result URL Hyperlinks Baseline Characters Participant Flow Adverse Events Outcome Measures Description
Link To Protocol
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 16/10/2017 Modified Completed: recruitment & data analysis complete Open to recruitment: actively recruiting participants
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 06/07/2018 PACTR UPDATE Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Purpose of the trial 06/07/2018 PACTR UPDATE Supportive care Treatment: Drugs
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 06/07/2018 PACTR UPDATE Other Eye Diseases, Surgery, Other, Anaesthesia