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.: PACTR201801002886341 Date of Approval: 17/12/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Neostigmine-lidocaine admixture for tourniquet pain management in Bier's block
Official scientific title Fentanyl consumption for tourniquet pain management while using neostigmine-lidocaine admixture versus lidocaine in Bier's block for upper limb surgeries.
Brief summary describing the background and objectives of the trial Tourniquet pain and speedy washout of local anesthetic after removal of the tourniquet in patients undergoing Bier's block for upper limb surgeries are considered drawbacks, they limit the use of such an easy and mostly safe anesthetic technique. Consequently, we evaluate the effects of using neostigmine-lidocaine admixture on tourniquet pain and postoperative analgesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Injury, Occupational Diseases, Poisoning,Surgery,upper limb surgeries
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 04/12/2012
Actual trial start date 14/05/2013
Anticipated date of last follow up 16/10/2013
Actual Last follow-up date 18/06/2014
Anticipated target sample size (number of participants) 62
Actual target sample size (number of participants) 66
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 randomization was done using research randomizer.org software sealed opaque closed 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 lidocaine 40 ml of 0.5% lidocaine Hcl once The research drug was injected over 1 minute 33 Active-Treatment of Control Group
Experimental Group Neostigmine-lidocaine 0.5 mg neostigmine in 40 ml of 0.5% lidocaine Hcl once The research drugs were injected over 1 minute 33
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients submitted to elective forearm and hand surgeries. Age between 18-65 years. Males and females. ASA physical status I and II. ¿ Patients suffering from any of the subsequent medical problems:bronchial asthma, Raynaud¿s disease, Sickle cell anaemia, cardiac conduction abnormalities. ¿ Allergy to either lidocaine and/or neostigmine. ¿ Emergency surgeries. ¿ Surgeries exceeding 1 hour duration. ¿ Patients subjected to general anesthesia during surgery. 18 Year(s) 65 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 25/09/2012 Research ethics committee
Ethics Committee Address
Street address City Postal code Country
Kasr Al Ainy st. Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome intraoperative fentanyl consumption for each group. Fentanyl 25 ¿g incremental doses at 5 minutes interval were given for analgesia in patients experiencing tourniquet pain with VAS > 3
Secondary Outcome Onset of tourniquet Pain. Time when intraoperative tourniquet pain started.
Secondary Outcome Number of patients suffering from tourniquet pain. At time of tourniquet deflation.
Secondary Outcome VAS (Visual analogue scale) Every 5 minutes subsequent to tourniquet inflation. At 30 minutes interval for 2 hours postoperative. Every hour for 4 hours thereafter
Secondary Outcome Time to first rescue analgesic. Time at which VAS>3 in postoperative period
Secondary Outcome Onset of sensory block. Time interval between giving the research drug and sensory block.
Secondary Outcome Onset of motor block Time interval between giving the research drug and motor block.
Secondary Outcome Sensory recovery time. Time interval between tourniquet deflation and sensory recovery
Secondary Outcome Motor recovery time. Time interval between tourniquet deflation and motor recovery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo university hospitals Kasr Al Ainy St. Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Anesthesia departement, Cairo university Kasr Al Ainy St. Cairo 11562 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo university hospitals Kasr Al Ainy St. Cairo 11562 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Omar Wageeh Abbas 18 Abd el Azim Salama st. Nasr city Cairo 11762 Egypt
Hesham Abd-El-Wahab Abu-El-Dahab 6 Tahrir st. Dokki Cairo 12611 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Omar Abbas w_a_g_i_h@live.com 01006367148 18 Abd el Azim st. Nasr city
City Postal code Country Position/Affiliation
Cairo 11762 Egypt Professor of anesthesia, surgical intensive care and pain medicine, Cairo university
Role Name Email Phone Street address
Public Enquiries Hesham Abu el Dahab meshodoctor@gmail.com 01016644419 6 Tahrir st. Dokki
City Postal code Country Position/Affiliation
Giza 112611 Egypt Assistant professor of anesthesia, surgical intensive care and pain medicine, Cairo university
Role Name Email Phone Street address
Scientific Enquiries Rania Fahmy ransam98@gmail.com 01222651063 13 Massarra st. Shoubra
City Postal code Country Position/Affiliation
Cairo 11231 Egypt Lecturer of anesthesia, surgical intensive care and pain medicine, Cairo university
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 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