AnalgesiaIntrathecalNCT05347173
Dexmedetomidine Versus Nalbuphine as an Adjuvant to Intrathecal Bupivacaine
A study testing Dexmedetomidine and Nalbuphine in people with Analgesia, run by Mansoura University at 1 site in Egypt.
Trial summary
Spinal anesthesia is the most consistent block for lower abdomen and lower limb surgical procedures. Over years many drugs have been used as an additive to spinal anesthesia in order to prolong the duration of action and to provide adequate postoperative analgesia. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Dexmedetomidine and Nalbuphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Jun 2022to 12 Mar 2024
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20 and 60 years.
- Both genders.
- Patients scheduled for lower limb orthopedic surgeries under spinal anesthesia.
- American society of anesthesiologists (ASA) class I or II.
Who cannot join
- Patient refusal.
- Age <20 or >60 years.
- Contraindications to spinal anesthesia (e.g. bleeding diathesis, spinal cord deformities, infection at injection site).
- History of allergy to any of the study medications.
- Cases with severe cardiac, renal, or hepatic disease.
- American society of anesthesiologists (ASA) class III, IV.
- Patient on regular analgesics or opioid abuse.
- Patient with peripheral neuropathy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University-Emergency hospital-ICU
El Dakahlia, Mansoura, 35511
About this study
Official title: Dexmedetomidine Versus Nalbuphine as an Adjuvant to Intrathecal Bupivacaine in Lower Limb Surgeries
Spinal anesthesia is the most consistent block for lower abdomen and lower limb surgical procedures. Over years many drugs have been used as an additive to spinal anesthesia in order to prolong the duration of action and to provide adequate postoperative analgesia.
Dexmedetomidine, a highly selective α2 agonist is rapidly emerging as the choice of additive to spinal anesthesia in view of its property to provide analgesia however, it may be associated with bradycardia which may affect the hemodynamic stability.
Nalbuphine is an opioid with agonist actions in the kappa receptor and antagonist actions in the mu receptor, it produces analgesia and sedation and lesser side effects through antagonism at the mu receptor but, it could be associated with some side effects as: dizziness, bradycardia, nausea, vomiting, and pruritus and may be associated with respiratory depression.
Read the detailed description
This prospective, double blinded, randomized, controlled study will be held to compare Nalbuphine versus Dexmedetomidine as adjuvants to intrathecal Bupivacaine in spinal anesthesia in patients undergoing lower limb orthopedic surgeries
- Conditions
- Analgesia
- Being tested
- Dexmedetomidine, Nalbuphine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
patients who will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus Dexmedetomidine (10 µg in 0.5 mL normal saline)
NalbuphineDrug
patients who will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus Nalbuphine (1 mg in 0.5 mL normal saline)
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine group (B gp) | No intervention | Patients will receive 2.5 ml hyperbaric bupivacaine (0.5%) plus 0.5 ml normal saline |
| Bupivacaine-Dexmedetomidine group (BD gp) | Active comparator | Patients will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus 10 µg Dexmedetomidine in 0.5 mL normal saline Receives: Drug: Dexmedetomidine |
| Bupivacaine-Nalbuphine group (BN gp) | Active comparator | Patients will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus 1 mg Nalbuphine in 0.5 mL normal saline Receives: Drug: Nalbuphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The post-operative analgesic duration
Measured: during the first 24 postoperative hours
Secondary outcomes (9)
Onset of sensory block
from intrathecal injection till sensory block grade 2 at T10
Measured: After intrathecal injection up to 15 minutes
Onset of motor block
from intrathecal injection till reach Bromage scale 3
Measured: After intrathecal injection up to 15 minutes
Heart rate (HR)
beat per minute
Measured: Every 5 minutes after spinal injection for the first 30 minutes, and then every 15 minutes till the end of surgery
Mean arterial pressure (MAP)
mmHg
Measured: Every 5 minutes after spinal injection for the first 30 minutes, and then every 15 minutes till the end of surgery
Hypotension will be considered if there was 25% decrease below the baseline for Mean arterial pressure (MAP)
mmHg
Measured: every 5 minutes after spinal injection for the first 30 minutes, then every 15 minutes till the end of surgery and every 30 minutes for the first 6 hours postoperatively
Bradycardia will be considered if the heart rate is less than 50 beats/min
beat per minute
Measured: every 5 minutes after spinal injection for the first 30 minutes, then every 15 minutes till the end of surgery and every 30 minutes for the first 6 hours postoperatively
postoperative pain
visual analogue scale (VAS) marked from 0-10 (where 0 = no pain and 10 = worst pain imaginable)
Measured: at 0, 2, 4, 6, 8,12,18 and 24 hours postoperatively
side effects as Vomiting, Nausea, pruritus, shivering
incidence
Measured: Intraoperatively and for the first 24 hours postoperatively
sedation
via Ramsay scale [1= Patient is anxious and agitated or restless, or both, 2= Patient is co-operative, oriented, and tranquil, 3= Patient responds to commands only, 4= Patient exhibits brisk response to light glabellar tap or loud auditory stimulus, 5= Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus and 6=Patient exhibits no response]
Measured: at 0, 2, 4, 6, 8,12,18 and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start21 Jun 2022
- Primary completion30 Jan 2024
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Model description
- Via the sealed envelope method; the patients will be randomly assigned to three equal groups according to the administration of adjuvant to intrathecal Bupivacaine and its dose; * Bupivacaine group (B gp) will include patients who will receive 2.5 ml hyperbaric bupivacaine (0.5%) +0.5 ml normal saline. * Bupivacaine-Dexmedetomidine group (BDgp) will include patients who will receive 2.5 ml hyperbaric bupivacaine (0.5%) plus Dexmedetomidine (10 µg in 0.5 ml normal saline). * Bupivacaine-Nalbuphine group (BN gp) will include patients who will receive 2.5 ml hyperbaric bupivacaine (0.5%) plus Nalbuphine (1 mg in 0.5ml normal saline).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maha abou-zeid, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347173
- Sponsor's protocol ID
- Dexmed+Nalbuph
- Acronym
- Intrathecal
- Status last verified
- Mar 2024
- First submitted
- 13 Apr 2022
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Nalbuphine as an Adjuvant to Intrathecal Bupivacaine in Lower Limb Surgeries
- ClinicalTrials.gov ID
- NCT05347173
- Acronym / sponsor ID
- Intrathecal / Dexmed+Nalbuph
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 26 Apr 2022 (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.
Spinal anesthesia is the most consistent block for lower abdomen and lower limb surgical procedures. Over years many drugs have been used as an additive to spinal anesthesia in order to prolong the duration of action and to provide adequate postoperative analgesia.
Dexmedetomidine, a highly selective α2 agonist is rapidly emerging as the choice of additive to spinal anesthesia in view of its property to provide analgesia however, it may be associated with bradycardia which may affect the hemodynamic stability.
Nalbuphine is an opioid with agonist actions in the kappa receptor and antagonist actions in the mu receptor, it produces analgesia and sedation and lesser side effects through antagonism at the mu receptor but, it could be associated with some side effects as: dizziness, bradycardia, nausea, vomiting, and pruritus and may be associated with respiratory depression.
Detailed description
This prospective, double blinded, randomized, controlled study will be held to compare Nalbuphine versus Dexmedetomidine as adjuvants to intrathecal Bupivacaine in spinal anesthesia in patients undergoing lower limb orthopedic surgeries
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Via the sealed envelope method; the patients will be randomly assigned to three equal groups according to the administration of adjuvant to intrathecal Bupivacaine and its dose; * Bupivacaine group (B gp) will include patients who will receive 2.5 ml hyperbaric bupivacaine (0.5%) +0.5 ml normal saline. * Bupivacaine-Dexmedetomidine group (BDgp) will include patients who will receive 2.5 ml hyperbaric bupivacaine (0.5%) plus Dexmedetomidine (10 µg in 0.5 ml normal saline). * Bupivacaine-Nalbuphine group (BN gp) will include patients who will receive 2.5 ml hyperbaric bupivacaine (0.5%) plus Nalbuphine (1 mg in 0.5ml normal saline).
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine group (B gp) | No intervention | –Patients will receive 2.5 ml hyperbaric bupivacaine (0.5%) plus 0.5 ml normal saline |
| Bupivacaine-Dexmedetomidine group (BD gp) | Active comparator | Drug: DexmedetomidinePatients will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus 10 µg Dexmedetomidine in 0.5 mL normal saline |
| Bupivacaine-Nalbuphine group (BN gp) | Active comparator | Drug: NalbuphinePatients will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus 1 mg Nalbuphine in 0.5 mL normal saline |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 20 and 60 years.
- Both genders.
- Patients scheduled for lower limb orthopedic surgeries under spinal anesthesia.
- American society of anesthesiologists (ASA) class I or II.
Key exclusion criteria (8 listed)
- Patient refusal.
- Age <20 or >60 years.
- Contraindications to spinal anesthesia (e.g. bleeding diathesis, spinal cord deformities, infection at injection site).
- History of allergy to any of the study medications.
- Cases with severe cardiac, renal, or hepatic disease.
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 |
|---|---|---|
| Dexmedetomidinepatients who will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus Dexmedetomidine (10 µg in 0.5 mL normal saline) | Drug | Bupivacaine-Dexmedetomidine group (BD gp) |
| Nalbuphinepatients who will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus Nalbuphine (1 mg in 0.5 mL normal saline) | Drug | Bupivacaine-Nalbuphine group (BN gp) |
Primary outcome
The post-operative analgesic duration
Time frame: during the first 24 postoperative hours
9 secondary outcomes
Onset of sensory block
Time frame: After intrathecal injection up to 15 minutes
Onset of motor block
Time frame: After intrathecal injection up to 15 minutes
Heart rate (HR)
Time frame: Every 5 minutes after spinal injection for the first 30 minutes, and then every 15 minutes till the end of surgery
Mean arterial pressure (MAP)
Time frame: Every 5 minutes after spinal injection for the first 30 minutes, and then every 15 minutes till the end of surgery
Hypotension will be considered if there was 25% decrease below the baseline for Mean arterial pressure (MAP)
Time frame: every 5 minutes after spinal injection for the first 30 minutes, then every 15 minutes till the end of surgery and every 30 minutes for the first 6 hours postoperatively
Bradycardia will be considered if the heart rate is less than 50 beats/min
Time frame: every 5 minutes after spinal injection for the first 30 minutes, then every 15 minutes till the end of surgery and every 30 minutes for the first 6 hours postoperatively
postoperative pain
Time frame: at 0, 2, 4, 6, 8,12,18 and 24 hours postoperatively
side effects as Vomiting, Nausea, pruritus, shivering
Time frame: Intraoperatively and for the first 24 hours postoperatively
sedation
Time frame: at 0, 2, 4, 6, 8,12,18 and 24 hours postoperatively
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 15 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Nalbuphine in people with Analgesia, run by Mansoura University 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 4 inclusion and 8 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 15 Mar 2024. 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?
The post-operative analgesic duration (time frame: during the first 24 postoperative hours). 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 15 Mar 2024.