Anesthesia, SpinalNCT04673812
Influence Of Low Dose Intrathecal Naloxone On Bupivacaine - Fentanyl Spinal Anaesthesia For Lower Limb Orthopedic Surgery In Elderly Patients
A study testing Bupivacaine-fentanyl in people with Anesthesia, Spinal and Elderly, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Fentanyl is a safer alternative than morphine in the management of postoperative pain in elderly. However, pruritus, nausea and vomiting are unwanted side effects of intrathecal fentanyl administration, that can decrease patient satisfaction with anaesthesia, delay post anaesthesia care unit ( PACU ) discharge, and… Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Anesthesia, Spinal, Elderly
- What is being tested?
- Bupivacaine-fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2020to 10 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60y of either gender.
- ASA physical status III or below.
- Patients scheduled for elective unilateral lower limb orthopedic surgery.
Who cannot join
- Morbid obese patients.
- Severe or uncompensated cardiovascular, renal, hepatic or endocrinal diseases.
- Allergy to one of the agents used.
- Severely altered consciousness level.
- Coagulopathy
- Increased intracranial pressure
Show all 11Show fewer
- Neuromuscular diseases
- Severe spinal deformity
- Patients on opioid analgesics or opioid abuse
- Multi traumatized patients
- Patients with preoperative Mini Mental State Examination ( MMSE ) scoring < 24
Trial locations and contacts
1 site in 1 country.
About this study
Fentanyl is a safer alternative than morphine in the management of postoperative pain in elderly. However, pruritus, nausea and vomiting are unwanted side effects of intrathecal fentanyl administration, that can decrease patient satisfaction with anaesthesia, delay post anaesthesia care unit ( PACU ) discharge, and increase costs.
The incidence of pruritus with neuraxial fentanyl is high. The incidence of pruritus in non-obstetric surgery patients after intrathecal fentanyl ranges from 53% to 79%.
Naloxone hydrochloride is a pure opioid competitive antagonist. Small doses of naloxone may reduce Fentanyl-associated adverse effects, such as pruritus, nausea and vomiting without affecting analgesia.
Read the detailed description
The aim of this study is to evaluate the effect of adding low dose intathecal naloxone to bupivacaine - fentanyl spinal anesthesia in elderly patients scheduled for unilateral lower limb orthopedic surgeries on opioid induced side effects namely pruritus, postoperative analgesia and the incidence of postoperative cognitive dysfunction (POCD) in elderly.
A four category verbal rating scale VRS-4 ( 0 to 3 scale ) will be used for assessment of intrathecal fentanyl induced side effects including pruritus, nausea, vomiting and shivering.
Mini Mental State Examination ( MMSE ) test will be applied to all patients pre- and post- operative to assess the incidence and the degree of POCD.
An 11 points Verbal Numerical Rating Scale VNRS for pain assessment will be also applied to all patients postoperatively to assess the effect on postoperative analgesia.
- Cannulation: Peripheral cannulae ( size 20 gauge or 18 gauge ) will be inserted to all patients . Ringer's acetate warmed up to 37°C will be infused slowly at rate of 7ml/kg, 30 min before induction of spinal anaesthesia. A single intravenous ( I.V. ) dose of prophylactic antibiotic after a negative sensitivity test will be given to all patients 15-30 min. before operation.
- Induction: Patient will receive spinal anaesthesia with 12.5 mg hyperbaric Bupivacaine 0.5% ( 2.5 mL ) plus 25 µg Fentanyl ( 0.5 mL ) and 20 µg Naloxone ( prepared in 0.5 mL normal saline ) added in the same syringe in a total volume of 3.5 mL..
- Spinal anaesthesia will be conducted while the patients are in the sitting position and under complete aseptic conditions; a lumber puncture at L3-4 or L4-5 interspaces will be performed with a 25- gauge Quincke spinal needle after infiltrating the skin with 2 ml of lidocaine 2%. After a successful dural puncture and ensuring free flow of cerebrospinal fluid, injectates will be injected slowly over 20 seconds without barbotage or aspiration according to group of the patient. Immediately, patients will be turned into the supine position. Oxygen 2-3 L/min will be applied to all patients via nasal prongs.
Evolution and regression of sensory and motor block will be evaluated. Sensation will be assessed by pinprick in the mid-clavicular line as follows; Grade 0: Sharp pain felt, Grade I: Analgesia, dull sensation felt, Grade II: Anesthesia, no sensation felt. Motor blockade will be assessed according to Modified Bromage Scale.
Hemodynamics ( mean arterial blood pressure MAP, heart rate HR and oxygen saturation SpO2 ) will be also recorded at predetermined accurate times.
- Conditions
- Anesthesia, Spinal, Elderly
- Being tested
- Bupivacaine-fentanyl
- Keywords
- spinal anesthesia, elderly, naloxone, pruritus, post operative cognitive dysfunction
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine-fentanylDrug
Also called Naloxone hydrochloride
Bupivacaine-Fentanyl (BF) group (46 patients): will receive spinal anaesthesia with 12.5 mg hyperbaric Bupivacaine 0.5% (2.5 mL) plus 25 µg Fentanyl (0.5 mL) and (0.5 mL) normal saline added in the same syringe in a total volume of 3.5 mL.
Bupivacaine-Fentanyl-Naloxone (BFN) group (46 patients): will receive spinal anaesthesia with 12.5 mg hyperbaric Bupivacaine 0.5% (2.5 mL) plus 25 µg Fentanyl (0.5 mL) and 20 µg Naloxone (prepared in 0.5 mL normal saline) added in the same syringe in a total volume of 3.5 mL.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine-Fentanyl Spinal Anaesthesia | Active comparator | Not described Receives: Drug: Bupivacaine-fentanyl |
| Bupivacaine-Fentanyl-Naloxone Spinal Anaesthesia | Active comparator | Not described Receives: Drug: Bupivacaine-fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of fentanyl - induced pruritus
A four category verbal rating scale VRS-4 ( 0 to 3 scale ) which will be will be explained to all patients, where ( 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms ) with the basal preoperative value is being recorded.
Measured: 4 hours postoperative
Secondary outcomes (3)
The time for first postoperative analgesic requirements
Measured: 24 hours
Cognitive function using Mini Mental State Examination (MMSE) scoring
Measured: 24 hours
postoperative nausea and vomiting
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start10 Dec 2020
- Primary completion10 Mar 2021
- Study completion10 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, SpinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University
- Responsible party
- Principal investigator, Khaled Abdelfattah Abdallah Sarhan, Kasr El Aini Hospital
- Investigators
- Mohamed Y. Makharita, professor, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673812
- Sponsor's protocol ID
- MS/19.09.830
- Status last verified
- Mar 2021
- First submitted
- 13 Dec 2020
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence Of Low Dose Intrathecal Naloxone On Bupivacaine - Fentanyl Spinal Anaesthesia For Lower Limb Orthopedic Surgery In Elderly Patients
- ClinicalTrials.gov ID
- NCT04673812
- Acronym / sponsor ID
- MS/19.09.830
- Conditions
- Anesthesia, Spinal, Elderly
- Keywords
- spinal anesthesia, elderly, naloxone, pruritus, post operative cognitive dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fentanyl is a safer alternative than morphine in the management of postoperative pain in elderly. However, pruritus, nausea and vomiting are unwanted side effects of intrathecal fentanyl administration, that can decrease patient satisfaction with anaesthesia, delay post anaesthesia care unit ( PACU ) discharge, and increase costs.
The incidence of pruritus with neuraxial fentanyl is high. The incidence of pruritus in non-obstetric surgery patients after intrathecal fentanyl ranges from 53% to 79%.
Naloxone hydrochloride is a pure opioid competitive antagonist. Small doses of naloxone may reduce Fentanyl-associated adverse effects, such as pruritus, nausea and vomiting without affecting analgesia.
Detailed description
The aim of this study is to evaluate the effect of adding low dose intathecal naloxone to bupivacaine - fentanyl spinal anesthesia in elderly patients scheduled for unilateral lower limb orthopedic surgeries on opioid induced side effects namely pruritus, postoperative analgesia and the incidence of postoperative cognitive dysfunction (POCD) in elderly.
A four category verbal rating scale VRS-4 ( 0 to 3 scale ) will be used for assessment of intrathecal fentanyl induced side effects including pruritus, nausea, vomiting and shivering.
Mini Mental State Examination ( MMSE ) test will be applied to all patients pre- and post- operative to assess the incidence and the degree of POCD.
An 11 points Verbal Numerical Rating Scale VNRS for pain assessment will be also applied to all patients postoperatively to assess the effect on postoperative analgesia.
- Cannulation: Peripheral cannulae ( size 20 gauge or 18 gauge ) will be inserted to all patients . Ringer's acetate warmed up to 37°C will be infused slowly at rate of 7ml/kg, 30 min before induction of spinal anaesthesia. A single intravenous ( I.V. ) dose of prophylactic antibiotic after a negative sensitivity test will be given to all patients 15-30 min. before operation.
- Induction: Patient will receive spinal anaesthesia with 12.5 mg hyperbaric Bupivacaine 0.5% ( 2.5 mL ) plus 25 µg Fentanyl ( 0.5 mL ) and 20 µg Naloxone ( prepared in 0.5 mL normal saline ) added in the same syringe in a total volume of 3.5 mL..
- Spinal anaesthesia will be conducted while the patients are in the sitting position and under complete aseptic conditions; a lumber puncture at L3-4 or L4-5 interspaces will be performed with a 25- gauge Quincke spinal needle after infiltrating the skin with 2 ml of lidocaine 2%. After a successful dural puncture and ensuring free flow of cerebrospinal fluid, injectates will be injected slowly over 20 seconds without barbotage or aspiration according to group of the patient. Immediately, patients will be turned into the supine position. Oxygen 2-3 L/min will be applied to all patients via nasal prongs.
Evolution and regression of sensory and motor block will be evaluated. Sensation will be assessed by pinprick in the mid-clavicular line as follows; Grade 0: Sharp pain felt, Grade I: Analgesia, dull sensation felt, Grade II: Anesthesia, no sensation felt. Motor blockade will be assessed according to Modified Bromage Scale.
Hemodynamics ( mean arterial blood pressure MAP, heart rate HR and oxygen saturation SpO2 ) will be also recorded at predetermined accurate times.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine-Fentanyl Spinal Anaesthesia | Active comparator | Drug: Bupivacaine-fentanyl |
| Bupivacaine-Fentanyl-Naloxone Spinal Anaesthesia | Active comparator | Drug: Bupivacaine-fentanyl |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 60y of either gender.
- ASA physical status III or below.
- Patients scheduled for elective unilateral lower limb orthopedic surgery.
Key exclusion criteria (11 listed)
- Morbid obese patients.
- Severe or uncompensated cardiovascular, renal, hepatic or endocrinal diseases.
- Allergy to one of the agents used.
- Severely altered consciousness level.
- Coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine-fentanylAlso: Naloxone hydrochlorideBupivacaine-Fentanyl (BF) group (46 patients): will receive spinal anaesthesia with 12.5 mg hyperbaric Bupivacaine 0.5% (2.5 mL) plus 25 µg Fentanyl (0.5 mL) and (0.5 mL) normal saline added in the same syringe in a total volume of 3.5 mL. Bupivacaine-Fentanyl-Naloxone (BFN) group (46 patients): will receive spinal anaesthesia with 12.5 mg hyperbaric Bupivacaine 0.5% (2.5 mL) plus 25 µg Fentanyl (0.5 mL) and 20 µg Naloxone (prepared in 0.5 mL normal saline) added in the same syringe in a total volume of 3.5 mL. | Drug | Bupivacaine-Fentanyl Spinal Anaesthesia, Bupivacaine-Fentanyl-Naloxone Spinal Anaesthesia |
Primary outcome
incidence of fentanyl - induced pruritus
Time frame: 4 hours postoperative
A four category verbal rating scale VRS-4 ( 0 to 3 scale ) which will be will be explained to all patients, where ( 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms ) with the basal preoperative value is being recorded.
3 secondary outcomes
The time for first postoperative analgesic requirements
Time frame: 24 hours
Cognitive function using Mini Mental State Examination (MMSE) scoring
Time frame: 24 hours
postoperative nausea and vomiting
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Y. Makharita, professor principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine-fentanyl in people with Anesthesia, Spinal and Elderly, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of fentanyl - induced pruritus (time frame: 4 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.