AnesthesiaNCT04783194
Dexamethasone Plus Bupivacaine Versus Bupivacaine in Bilateral Trans-incisional Paravertebral Block in Lumbar Spine Surgeries .
A study testing Dexamethasone+ Bupivacaine and Bupivacaine in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of this study is to compare addition of dexamethasone to bupivacaine versus bupivacaine alone for trans-incisional bilateral paravertebral block for postoperative analgesia in elective lumbar spine surgeries. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Dexamethasone+ Bupivacaine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2021to 20 Oct 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- physical status American Society of Anesthesiologists (ASA) I or II.
Who cannot join
- refuse to participate have a body mass index (BMI) >30 kg/m2 ASA physical status >II have major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological) coagulation abnormalities infection at the injection site tumor in the paravertebral space sepsis Severe chest deformity or scoliosis, due to the possibility of injection into the meninges an allergy or contraindications to the drugs used in the study uncontrolled diabetes patients with active gastric ulceration a history of drug addiction or alcohol abuse a psychiatric illness mental retardation interfering with the evaluation of pain scores.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexamethasone Plus Bupivacaine Versus Bupivacaine in Bilateral Trans-incisional Paravertebral Block in Lumbar Spine Surgeries, a Randomized Clinical Trial.
The purpose of this study is to compare addition of dexamethasone to bupivacaine versus bupivacaine alone for trans-incisional bilateral paravertebral block for postoperative analgesia in elective lumbar spine surgeries.
- Conditions
- Anesthesia
- Being tested
- Dexamethasone+ Bupivacaine, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone+ BupivacaineDrug
Dexamethasone plus bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery.
BupivacaineDrug
Bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone + bupivacaine in bilateral TiPVB in lumbar spine surgery | Active comparator | Dexamethasone plus bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery for postoperative analgesia Receives: Drug: Dexamethasone+ Bupivacaine |
| Bupivacaine in bilateral TiPVB in lumbar spine surgery | Active comparator | Bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery for postoperative analgesia Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
First time to analgesic requirement
After extubation, an IV PCA system will be connected to the patient (Accufuser Plus® 100 mL: Woo Young Medical Co, Korea). PCA will be prepared with 60 mL of normal saline containing 60 mg of morphine, and the system will be programmed to give a 0.5 mL bolus dose with a lockout interval of 8 min. basal rate will not be present. PCA will be discontinued at 24 h after surgery, and at that time, oral analgesics begin.
Measured: 1st 24 hour
Secondary outcomes (2)
Total opioid consumption .
Total opioid consumption in the first 24 h postoperatively .
Measured: 1st 24 hour
Visual analogue scale (VAS)
Pain scores will be evaluated by a blinded observer anesthesiologist at the time of arrival in the PACU and 10, 20, and 30 min and 1, 2, 4, 6, 12, and 24 h thereafter using a visual analog scale (VAS) (ranging from0-10 cm: where 0 = no pain, 10 = worst pain). The patients Will be instructed about the usage of the PCA system and the VAS preoperatively
Measured: 1st 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 posted5 Mar 2021
- Study start15 Mar 2021
- Primary completion15 Sep 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Mohammed Alansary Amin Ahmed Helwa, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783194
- Sponsor's protocol ID
- FMASU R 47/2020/2021
- Status last verified
- Dec 2022
- First submitted
- 28 Feb 2021
- Last updated
- 21 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Plus Bupivacaine Versus Bupivacaine in Bilateral Trans-incisional Paravertebral Block in Lumbar Spine Surgeries, a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04783194
- Acronym / sponsor ID
- FMASU R 47/2020/2021
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 5 Mar 2021 (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.
The purpose of this study is to compare addition of dexamethasone to bupivacaine versus bupivacaine alone for trans-incisional bilateral paravertebral block for postoperative analgesia in elective lumbar spine surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone + bupivacaine in bilateral TiPVB in lumbar spine surgery | Active comparator | Drug: Dexamethasone+ BupivacaineDexamethasone plus bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery for postoperative analgesia |
| Bupivacaine in bilateral TiPVB in lumbar spine surgery | Active comparator | Drug: BupivacaineBupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery for postoperative analgesia |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- physical status American Society of Anesthesiologists (ASA) I or II.
Key exclusion criteria (1 listed)
- refuse to participate have a body mass index (BMI) >30 kg/m2 ASA physical status >II have major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological) coagulation abnormalities infection at the injection site tumor in the paravertebral space sepsis Severe chest deformity or scoliosis, due to the possibility of injection into the meninges an allergy or contraindications to the drugs used in the study uncontrolled diabetes patients with active gastric ulceration a history of drug addiction or alcohol abuse a psychiatric illness mental retardation interfering with the evaluation of pain scores.
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 |
|---|---|---|
| Dexamethasone+ BupivacaineDexamethasone plus bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery. | Drug | Dexamethasone + bupivacaine in bilateral TiPVB in lumbar spine surgery |
| BupivacaineBupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery. | Drug | Bupivacaine in bilateral TiPVB in lumbar spine surgery |
Primary outcome
First time to analgesic requirement
Time frame: 1st 24 hour
After extubation, an IV PCA system will be connected to the patient (Accufuser Plus® 100 mL: Woo Young Medical Co, Korea). PCA will be prepared with 60 mL of normal saline containing 60 mg of morphine, and the system will be programmed to give a 0.5 mL bolus dose with a lockout interval of 8 min. basal rate will not be present. PCA will be discontinued at 24 h after surgery, and at that time, oral analgesics begin.
2 secondary outcomes
Total opioid consumption .
Time frame: 1st 24 hour
Visual analogue scale (VAS)
Time frame: 1st 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 21 Dec 2022.
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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 Dexamethasone+ Bupivacaine and Bupivacaine in people with Anesthesia, run by Ain Shams 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 1 inclusion and 1 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 21 Dec 2022. 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?
First time to analgesic requirement (time frame: 1st 24 hour). 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 21 Dec 2022.