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.: PACTR202304865602085 Date of Approval: 04/04/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title postoperative intrathecal analgesia for lumber spine surgery
Official scientific title Efficacy and safety of preemptive intrathecal morphine versus nalbuphine in lumbar spine surgery: A randomized clinical trial.
Brief summary describing the background and objectives of the trial Intrathecal morphine is an effective analgesia method for managing postoperative pain after spine surgery. however it has some complications that have been reported as respiratory depression, urine retention, pruritis, nausea and vomiting as its pure mu receptor agonist.Nalbuphine is an opioid with agonist actions in the kappa receptor and antagonist actions in the mu receptor. Because of this mixed agonist antagonist effects, it produces analgesia and sedation through agonism at the kappa receptor and lesser side effects through antagonism at the mu receptor. The aim of this study is to evaluate efficacy and safety of preemptive intrathecal injection of morphine compared to nalbuphine in posterior lumbar interbody fusion surgery under general anesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial postoperative analgesia
Anticipated trial start date 01/05/2023
Actual trial start date
Anticipated date of last follow up 01/11/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 88
Actual target sample size (number of participants)
Recruitment status Active, not 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 intrathecal morphine three ml volume containing 2 ml of 0.9% saline and 0.2 mg morphine diluted in 1 ml 0.9% saline. intrathecal injection once before induction of general anesthesia intrathecal injection of three ml volume containing 2 ml of 0.9% saline and 0.2 mg morphine diluted in 1 ml 0.9% saline before induction of general anesthesia 44 Active-Treatment of Control Group
Experimental Group intrathecal nalbuphine three ml volume containing 2 ml of 0.9% saline and 0.8 mg nalbuphine diluted in 1 ml 0.9% saline. intrathecal injection once before induction of general anesthesia intrathecal injection of 3 ml volume containing 2 ml of 0.9% saline and 0.8 mg nalbuphine diluted in 1 ml 0.9% saline. once before induction of general anesthesia 44
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
both sex ASA physical status I &II age range 30-60 years old scheduled to undergo elective open posterior lumbar interbody fusion surgery at 1 or 2 level • Body mass index >35 kg/m2. • Patients with neurological deficit (symptoms of lumbar intervertebral nerve injury (determined by a neurosurgical specialist based on physical and imaging examinations). • Redo or previous lumber surgery. • Allergy or contraindication to the given study drugs. • Patients on chronic pain medication. • Chronic alcoholism, history of a major psychiatric disorder or cognitive disorder (inability to understand the VAS). • Any contraindication to intrathecal injection. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 70 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 18/02/2023 Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
elgeish street Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The duration of effective analgesia from the intrathecal injection to the first rescue analgesic requirement or VAS more than 3 postoperative
Secondary Outcome pain score at arrival to PACU, 1, 2, 4,6, 12, 18, 24 hours postoperatively
Secondary Outcome adverse effects e.g. PONV, pruritus, respiratory depression, urinary retention, sedation for 24 hours postoperative
Secondary Outcome postoperative fentanyl consumption from the end of the surgery up to 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Faculty of Medicine elgeish street Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Mona Raafat Elghamry elgeish street Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Mona Raafat Elghamry elgeish street Tanta 31527 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Mona Raafat Elghamry elgeish street Tanta 31527 Egypt
Nashwa Ebrahim Hamoda elgeish street Tanta 31527 Egypt
Marwa Ahmed Eloraby Elfert elgeish street Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mona Elghamry drmonagh19802000@gmail.com +201060101867 elgeish street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant Professor
Role Name Email Phone Street address
Public Enquiries Nashwa Hamoda Nashwa741987@gmail.com +201020526560 elgeish street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Marwa Elfert dr.marwaoraby5@gmail.com +201008618309 elgeish street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes de-identified individual trial participant data as statistics of onset and duration of sensory and motor block, pain score, hemodynamic parameters, side effects,and patients satisfaction were intended to be shared Statistical Analysis Plan IPD will be shared after finishing and publication of the study.and it will be available for 6 months the IPD will be available for scientific researcher up on e-mail request with reason of the request. request will be sent to email of 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