Paravertebral BlockNCT03480308
Effect of Addition of Fentanyl or Dexamethasone or Both to Bupivacaine in Paravertebral Block for Patients Undergoing Major Breast Surgery
A study testing Fentanyl, Dexamethasone and Bupivacaine in people with Paravertebral Block, run by Assiut University at 1 site in Egypt.
Trial summary
This study evaluated the analgesic efficacy of fentanyl and dexamethasone in combination with bupivacaine for single-shot paravertebral block (PVB) in patients undergoing major breast surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Paravertebral Block
- What is being tested?
- Fentanyl, Dexamethasone and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 30 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 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18-70 years.
- Sex: females
- ASA physical status: I-II.
- Operation: major breast surgery
Who cannot join
- - Patient refusal.
- History of cardiac disease, psychological disorders, respiratory diseases including asthma, renal or hepatic failure.
- Coagulation disorders.
- Infection at the puncture site
- Allergy to study medications.
- Chronic use of pain medications.
- Respiratory tract in¬fection within the last 2 weeks.
- Neurological deficit
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Amonios Khalil gerges
Asyut
Amonios Khalil, 01023466456, amonios_khalil@yahoo.com
About this study
This study evaluated the analgesic efficacy of fentanyl and dexamethasone in combination with bupivacaine for single-shot paravertebral block (PVB) in patients undergoing major breast surgery.
Read the detailed description
This study evaluated the analgesic efficacy of fentanyl and dexamethasone in combination with bupivacaine for single-shot paravertebral block (PVB) in patients undergoing major breast surgery.
Patients will receive ultrasound guided paravertebral block and stratified into 3 groups according to medication used :
Group 1 : bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg Group 2 : bupivacaine (0.5%) 20 ml , dexamethasone 4 mg Group 2 : bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg , dexamethasone 4 mg
- Conditions
- Paravertebral Block
- Being tested
- Fentanyl, Dexamethasone, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg in paravertebral block
DexamethasoneDrug
Patients will receive bupivacaine (0.5%) 20 ml , Dexamethasone 4mg in paravertebral block
BupivacaineDrug
Bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine fentanyl group | Active comparator | Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg in paravertebral block Receives: Drug: Fentanyl; Drug: Bupivacaine |
| Bupivacaine dexamethasone group | Active comparator | Patients will receive bupivacaine (0.5%) 20 ml , dexamethasone 4 mg in paravertebral block Receives: Drug: Dexamethasone; Drug: Bupivacaine |
| Bupivacaine fentanyl dexamethasone group | Active comparator | Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg , dexamethasone 4 mg in paravertebral block Receives: Drug: Fentanyl; Drug: Dexamethasone; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first analgesic request
Measured: one day postoperative
pain assessment
Pain assessment by the aid of Visual analogue scale (VAS) Ranging from 0=no pain, 10=excruciating pain higher values represent worse outcome
Measured: one day postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Apr 2018
- Primary completion1 Apr 2019
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paravertebral BlockStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will receive ultrasound guided paravertebral block and stratified into 3 groups according to medication used : Group 1 : bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg Group 2 : bupivacaine (0.5%) 20 ml , dexamethasone 4 mg Group 2 : bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg , dexamethasone 4 mg
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amonios khalil, Assiut University
- Investigators
- Amonios khalil, Study director, Faculty of medicine-Assiut university-Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480308
- Sponsor's protocol ID
- paravertebral block
- Status last verified
- Feb 2021
- First submitted
- 16 Mar 2018
- Last updated
- 23 Feb 2021
- 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 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Addition of Fentanyl or Dexamethasone or Both to Bupivacaine in Paravertebral Block for Patients Undergoing Major Breast Surgery
- ClinicalTrials.gov ID
- NCT03480308
- Acronym / sponsor ID
- paravertebral block
- Conditions
- Paravertebral Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 29 Mar 2018 (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.
This study evaluated the analgesic efficacy of fentanyl and dexamethasone in combination with bupivacaine for single-shot paravertebral block (PVB) in patients undergoing major breast surgery.
Detailed description
This study evaluated the analgesic efficacy of fentanyl and dexamethasone in combination with bupivacaine for single-shot paravertebral block (PVB) in patients undergoing major breast surgery.
Patients will receive ultrasound guided paravertebral block and stratified into 3 groups according to medication used :
Group 1 : bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg Group 2 : bupivacaine (0.5%) 20 ml , dexamethasone 4 mg Group 2 : bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg , dexamethasone 4 mg
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Patients will receive ultrasound guided paravertebral block and stratified into 3 groups according to medication used : Group 1 : bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg Group 2 : bupivacaine (0.5%) 20 ml , dexamethasone 4 mg Group 2 : bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg , dexamethasone 4 mg
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine fentanyl group | Active comparator | Drug: Fentanyl, Drug: BupivacainePatients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg in paravertebral block |
| Bupivacaine dexamethasone group | Active comparator | Drug: Dexamethasone, Drug: BupivacainePatients will receive bupivacaine (0.5%) 20 ml , dexamethasone 4 mg in paravertebral block |
| Bupivacaine fentanyl dexamethasone group | Active comparator | Drug: Fentanyl, Drug: Dexamethasone, Drug: BupivacainePatients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg , dexamethasone 4 mg in paravertebral block |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18-70 years.
- Sex: females
- ASA physical status: I-II.
- Operation: major breast surgery
Key exclusion criteria (8 listed)
- - Patient refusal.
- History of cardiac disease, psychological disorders, respiratory diseases including asthma, renal or hepatic failure.
- Coagulation disorders.
- Infection at the puncture site
- Allergy to study medications.
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 |
|---|---|---|
| FentanylPatients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg in paravertebral block | Drug | Bupivacaine fentanyl dexamethasone group, Bupivacaine fentanyl group |
| DexamethasonePatients will receive bupivacaine (0.5%) 20 ml , Dexamethasone 4mg in paravertebral block | Drug | Bupivacaine dexamethasone group, Bupivacaine fentanyl dexamethasone group |
| BupivacaineBupivacaine | Drug | Bupivacaine dexamethasone group, Bupivacaine fentanyl dexamethasone group, Bupivacaine fentanyl group |
Primary outcome
Time to first analgesic request
Time frame: one day postoperative
pain assessment
Time frame: one day postoperatively
Pain assessment by the aid of Visual analogue scale (VAS) Ranging from 0=no pain, 10=excruciating pain higher values represent worse outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
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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.
Amonios khalil study director
Faculty of medicine-Assiut university-Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl, Dexamethasone and Bupivacaine in people with Paravertebral Block, run by Assiut 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: status not confirmed, as of the sponsor's last update on 23 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amonios khalil (01023466456, amonios_khalil@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first analgesic request (time frame: one day postoperative). The study lists 2 primary outcomes in all. 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 23 Feb 2021.