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.: PACTR201901839969911 Date of Registration: 16/01/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Perfusion index as a predictor of the efficacy of rescue analgesia after major abdominal surgeries
Official scientific title Pulse oximetry derived perfusion index as a predictor of the efficacy of rescue analgesia after major abdominal surgeries
Brief summary describing the background and objectives of the trial This study aims primarily to investigate the usefulness of the PI as an objective indicator of pain in pain assessment in non-sedated non intubated surgical ICU patients by examining the relationship between the PI and the BPS-NI before and after rescue analgesia given. Our secondary aim is to detect sex and age related changes in PI after pain control with rescue analgesics
Type of trial CCT
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 Diagnosis / Prognosis
Anticipated trial start date 15/01/2019
Actual trial start date
Anticipated date of last follow up 15/04/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Not yet 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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group rescue analgesia 5 mg Nalbuphine and 1g paracetamol were given intravenous bolus once pain control in patients less than 60 years old 20 Uncontrolled
Experimental Group rescue analgesia 5 mg Nalbuphine and 1g paracetamol were given intravenous bolus once pain control in patients more than 60 years old 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients with American Society of Anaesthesiologists (ASA) physical status I and II both sex 18 -80 years of age non-sedated non-intubated patients that were admitted to the Ain Shams teaching hospital - Assembled surgical intensive care unit, after major abdominal surgery fever hypothermia history of a neurological disorder psychiatric disorder dementia chronic pain disorder patients who were taking psychotropic drugs allergy to any drug used in the study mental retardation unstable hemodynamic status unconscious patients Patients who had combined general epidural anaesthesia or transverse abdominis plane (TAP) block Legally acceptable presentative of patients not willing to provide their voluntary written informed consent 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) 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 23/01/2019 AIN shams university research ethics committee
Ethics Committee Address
Street address City Postal code Country
abbasyia cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome This study aimed primarily to investigate the usefulness of the PI as an objective indicator of pain At the time of the first request for analgesia ,Thirty minutes after postoperative analgesia
Secondary Outcome to detect sex and age-related changes in PI after pain control with rescue analgesics. At the time of the first request for analgesia, Thirty minutes after postoperative analgesia
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams university hospital abbasyia street Cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ashraf Nabil Fifth Settlement Cairo 11835 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ashraf nabil abbasya cairo 11566 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Raham Hasam Mostafa Nasr City Cairo 11759 Egypt
Amr Fouad Hafez Fifth Settlement Cairo 11835 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ashraf Nabil ashraf_nabel@med.asu.edu.eg +201001100613 fifth settlement
City Postal code Country Position/Affiliation
cairo 11566 Egypt lecturer of anesthesia ain shams university
Role Name Email Phone Street address
Public Enquiries Raham Mostafa rahamhasan@yahoo.com +201222530020 nasr city
City Postal code Country Position/Affiliation
cairo 11566 Egypt lecturer of anesthesia ain shams university
Role Name Email Phone Street address
Scientific Enquiries Amr Hafez amrfouad85@gmail.com +201225674370 fifth settlement
City Postal code Country Position/Affiliation
cairo 11566 Egypt lecturer of anesthesia ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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