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.: PACTR202303901133915 Date of Approval: 31/03/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title side effects of intrathecal morphine in orthopedic surgery
Official scientific title The impact of adding Nalbuphine or Naloxone to intrathecal morphine as adjuvants on morphine linked side effects in orthopedic surgery: A randomized controlled study.
Brief summary describing the background and objectives of the trial Nalbuphine is an opioid with 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. Naloxone is a μ-opioid receptor antagonist. it can enhance the postoperative pain-relieving effects of opioids and reduce their dosage. The aim of the study is to evaluate the effect of adding naloxone or nalbuphine to intrathecal bupivacaine and morphine in lower limb orthopedic surgeries to reduce morphine related side effects.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Orthopaedics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial anesthesia
Anticipated trial start date 01/05/2023
Actual trial start date
Anticipated date of last follow up 31/10/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 126
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 anesthesia Patients will be received 0.2mg morphine mixed with 12.5 mg hyperbaric bupivacaine 0.5 % (total volume 3 ml). intrathecal injection of local anesthetic at the start of the surgery subarachnoid injection of the drugs at the lumber region between L3 and L4 vertebrae 42 Dose Comparison
Experimental Group intrathecal anesthesia Patients will be received 0.2mg morphine and 0.8 mg nalbuphine mixed with 12.5 mg hyperbaric bupivacaine 0.5 % (total volume 3 ml). intrathecal injection of local anesthetic at the start of the surgery subarachnoid injection of the drugs at the lumber region between L3 and L4 vertebrae 42
Experimental Group intrathecal anesthesia Patients will be received 0.2mg morphine and 20 µg of naloxone mixed with 12.5 mg hyperbaric bupivacaine 0.5 % (total volume 3 ml). intrathecal injection of local anesthetic at the start of the surgery subarachnoid injection of the drugs at the lumber region between L3 and L4 vertebrae 42
Experimental Group intrathecal anesthesia Patients will be received 0.2mg morphine and 0.8 mg nalbuphine mixed with 12.5 mg hyperbaric bupivacaine 0.5 % (total volume 3 ml). intrathecal injection of local anesthetic at the start of the surgery subarachnoid injection of the drugs at the lumber region between L3 and L4 vertebrae 42
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
both sex ASA physical status I &II age 50-80 years old scheduled to undergoing elective lower orthopedic surgery. • Body mass index ≥ 35. • Diabetes Mellitus • Allergy to the study drugs. • Chronic alcoholism. • Patient with significant neurological and psychiatric disorders. • Any contraindications to spinal anesthesia. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 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 adverse effects nausea, pruritus,urinary retention intraoperative and for 24 hours postoperative
Secondary Outcome onset of sensory and motor block from the end of intrathecal injection to onset of sensory and motor block before start of surgery
Secondary Outcome duration of sensory block from end of intrathecal injection to first analgesic request postoperative
Secondary Outcome duration of motor block from the end of intrathecal injection to Bromage scale zero postoperative
Secondary Outcome pain assessment by visual analog scale VAS score postoperative Pain will be assessed by VAS at PACU then after 0.5 ,1 ,2 ,6 ,8 ,12 ,24 hours postoperatively.
Secondary Outcome Total amount of rescue analgesics that required postoperative for 24 hours postoperative
Secondary Outcome Hemodynamics changes: heart rate and mean arterial blood pressure Intraoperative hemodynamic monitoring before intrathecal injection as baseline then at 5, 10, 15 min after performing technique and every 15 min until the end of the procedure.
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
Marwa Ahmed Eloraby Elfert elgeish street Tanta 31527 Egypt
Nashwa Ebrahim Hamoda elgeish street Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mona Elghamry drmonagh19802000@gmail.com +201060101867 elgeish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant Professor
Role Name Email Phone Street address
Public Enquiries Marwa Elfert dr.marwaoraby5@gmail.com +201008618309 elgeish street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Nashwa Hamoda Nashwa741987@gmail.com +201020526560 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 side effects nausea pruritus urine retention onset and duration of sensory and motor block VAS score and hemodynamic parameters 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 e-mail 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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 09/04/2025 rephrasing after plagiarism check The effect of adding Nalbuphine or Naloxone as an adjuvant to intrathecal morphine and bupivacaine on morphine related side effects in orthopedic surgeries: A randomized controlled study. The impact of adding Nalbuphine or Naloxone to intrathecal morphine as adjuvants on morphine linked side effects in orthopedic surgery: A randomized controlled study.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 09/04/2025 common age both sex ASA physical status I &II age 20-60 years old scheduled to undergoing elective lower orthopedic surgery. both sex ASA physical status I &II age 50-80 years old scheduled to undergoing elective lower orthopedic surgery.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 09/04/2025 common age Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s) Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 09/04/2025 the optimum dose Experimental Group, intrathecal anesthesia, Patients will be received 0.2mg morphine and 1 mg nalbuphine mixed with 12.5 mg hyperbaric bupivacaine 0.5 % (total volume 3 ml)., intrathecal injection of local anesthetic at the start of the surgery, subarachnoid injection of the drugs at the lumber region between L3 and L4 vertebrae , 42, Experimental Group, intrathecal anesthesia, Patients will be received 0.2mg morphine and 0.8 mg nalbuphine mixed with 12.5 mg hyperbaric bupivacaine 0.5 % (total volume 3 ml)., intrathecal injection of local anesthetic at the start of the surgery, subarachnoid injection of the drugs at the lumber region between L3 and L4 vertebrae , 42,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/03/2023 ethical committee approval letter is uploaded TRUE, research ethics committee, elgeish street, Tanta, 31527, Egypt, , 18 Feb 2023, +200403332033, qau@med.tanta.edu.eg, 25414_24242_4737.pdf TRUE, research ethics committee, elgeish street, Tanta, 31527, Egypt, , 18 Feb 2023, +200403332033, qau@med.tanta.edu.eg, 25414_24242_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 23/03/2023 complete ethical approval letter was uploaded at the top the title of the committee at the bottom the stamp and the signature of the chef of the committee TRUE, research ethics committee, elgeish street, Tanta, 31527, Egypt, , 18 Feb 2023, +200403332033, qau@med.tanta.edu.eg, 25414_24242_4737.pdf TRUE, research ethics committee, elgeish street, Tanta, 31527, Egypt, , 18 Feb 2023, +200403332033, qau@med.tanta.edu.eg, 25414_24242_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 27/03/2023 complete ethical approval letter TRUE, research ethics committee, elgeish street, Tanta, 31527, Egypt, , 18 Feb 2023, +200403332033, qau@med.tanta.edu.eg, 25414_24242_4737.pdf TRUE, research ethics committee, elgeish street, Tanta, 31527, Egypt, , 18 Feb 2023, +200403332033, qau@med.tanta.edu.eg, 25414_24242_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 22/03/2023 statement as WHO requirement statistics of side effects nausea pruritus urine retention onset and duration of sensory and motor block VAS score and hemodynamic parameters de-identified individual trial participant data as statistics of side effects nausea pruritus urine retention onset and duration of sensory and motor block VAS score and hemodynamic parameters were intended to be shared
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Minimum age 09/04/2025 common age 20 Year(s) 50 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Maximum age 09/04/2025 common age 60 Year(s) 80 Year(s)