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.: PACTR202104609519383 Date of Approval: 12/04/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title opioid sparing analgesia post-thoracotomy
Official scientific title Preemptive subcutaneous nalbuphine for Opioid sparing analgesia after thoracotomy: A prospective Randomized Clinical Trial
Brief summary describing the background and objectives of the trial thoracic epidural analgesia (TEA) is considered the ‘gold standard’ of perioperative care after thoracotomy, other local and regional techniques have emerged within recent years and seem to become valid alternatives to TEA.Morphine is the standard opioid analgesic for pain control. When it is used appropriately, about 80% of patients will achieve adequate pain relief. However, many patients may change to an alternative opioid, because of the intolerable adverse effects associated with morphine.Preemptive analgesia with Nalbuphine can improve the efficacy of postoperative analgesia and effectively reduce inflammatory reaction in the old patients undergoing thoracotomy.The aim of our study is to evaluate the postoperative opioid sparing effects of preemptive subcutaneous injection of nalbuphine for analgesia in thoracotomy.
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 Treatment: Drugs
Anticipated trial start date 01/05/2021
Actual trial start date
Anticipated date of last follow up 01/05/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants)
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 Simple randomization using a randomization table created by a computer software program Sealed opaque 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 placebo general anesthesia with subcutaneous normal saline injection after induction single dose injection of subcutaneous normal saline after induction of anesthesia the general anesthesia (GA) will be induced with 2 mg/kg of propofol, 2 µg/kg of fentanil, 0.2 mg/kg of cisatracurium.single dose injection of subcutaneous normal saline after induction of anesthesia. Then, the GA will be maintained by inhaling 2.5%-3.0% sevoflurane (1.3-1.5 MAC) to keep the bispectral index (BIS) value between 40 and 60. 35 Placebo
Experimental Group nalbuphine nalbuphine 0.2 mg/kg will be injected subcutaneously after the general anesthesia single dose injection of subcutaneous nalbuphine after induction of anesthesia the general anesthesia (GA) will be induced with 2 mg/kg of propofol, 2 µg/kg of fentanil, 0.2 mg/kg of cisatracurium.single dose injection of subcutaneous nalbuphine after induction of anesthesia. Then, the GA will be maintained by inhaling 2.5%-3.0% sevoflurane (1.3-1.5 MAC) to keep the bispectral index (BIS) value between 40 and 60. 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients of both sex, American Society of Anesthesiologists (ASA) physical status I, II and III, aged 20 to 80 years selected for open thoracic surgery Patients with allergy to nalbuphine or morphine; opioid abuse, history of chronic pain, recurrent operation, pregnancy; uncontrolled hepatic or renal diseases; neurologic or psychiatric illnesses that would interfere with assessment of pain score Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 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 15/03/2021 Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Elgeish st Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative consumptions of morphine first 24 hours postoperative
Secondary Outcome The intraoperative consumptions of fentanyl the whole time of operarion
Secondary Outcome Time to first dose of opioid analgesia postoperative 24 hours postoperative
Secondary Outcome acute pain assessment arrival to PACU, then after 1,2,4,6, 8,12,18,24 hours postoperative
Secondary Outcome chronic pain assessment 3 and 6 months postoperative
Secondary Outcome Length of hospital stay postoperative period in hospital
Secondary Outcome The incidence of postoperative opioid-related adverse events 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Facualty of Medicine El-Geish st Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr mona raafat elghamry Elgeish st Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr mona raafat elghamry Elgeish st Tanta 31527 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Mona Raafat Elghamry Elgeish st Tanta 31527 Egypt
Atteia Gad Anwar Elgeish st Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Atteia Anwar atteiagad@gmail.com +201025547544 Elgeish st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries Mona Elghamry drmonagh19802000@gmail.com +201060101867 Elgeish st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
Role Name Email Phone Street address
Principal Investigator Mona Elghamry drmonagh19802000@gmail.com +201060101867 Elgeish st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer of anesthesia and surgical intensive care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes statistics of intraoperative and postoperative opioid consumption, time to first analgesic request postoperative, acute and chronic pain postoperative, length of hospital stay, and postoperative complucations Statistical Analysis Plan IPD will be shared after finishing and publication of the study.and it will be available for 1 year. the IPD will be available for scientific research purpose only up on e-mail request with reason of the request. request will be sent to e-mail (drmonagh19802000@gmail.com)
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