Spinal AnesthesiaNCT06050044
Intrathecal Injection of Hyperbaric Bupivacaine Versus a Mixture of Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Lower Abdominal Surgery
A study testing Group A (hyperbaric bupivacaine) and Group B (Mixture of Hyperbaric and Isobaric Bupivacaine) in people with Spinal Anesthesia and Hyperbaric Bupivacaine, run by Helwan University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the effects of intrathecal injection of hyperbaric bupivacaine versus injection of hyperbaric and isobaric bupivacaine in patients undergoing lower abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Anesthesia, Hyperbaric Bupivacaine, Isobaric Bupivacaine
- What is being tested?
- Group A (hyperbaric bupivacaine) and Group B (Mixture of Hyperbaric and Isobaric Bupivacaine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 1 Jul 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-65 years old.
- Both sexes.
- American Society of Anaesthesia (ASA) I to II.
- Undergoing lower abdominal or urological surgery under spinal anesthesia
Who cannot join
- Allergy to amide.
- Patients with a significant history of substance abuse.
- Patients with diabetes mellitus, neurological or cardiovascular diseases.
- Patients with neuromuscular diseases.
- Pregnant patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrathecal Injection of Hyperbaric Bupivacaine Versus a Mixture of Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Lower Abdominal Surgery: A Randomized Controlled Trial
The aim of this study is to compare the effects of intrathecal injection of hyperbaric bupivacaine versus injection of hyperbaric and isobaric bupivacaine in patients undergoing lower abdominal surgery.
Read the detailed description
Spinal anesthesia is one of the most commonly used nerve block procedures for surgical operations involving the lower abdomen, the perineum, and the lower limbs, owing to its quick effect and cost-effectiveness. Spinal anesthesia is advantageous in that it uses a small dose of anesthesia, is simple to perform, and offers a rapid onset of action, reliable surgical analgesia, and good muscle relaxation.
The Baricity of a solution is defined as the ratio of the density of the solution to that of the cerebrospinal fluid (CSF). The most common anesthetic used for SA in obstetric and non-obstetric surgery is bupivacaine, which can be formulated as an isobaric or hyperbaric solution. Baricity differences between spinal anesthetic solutions are thought to affect hemodynamic parameters and distribution within the subarachnoid space, which may, in turn, affect the onset, extent, and duration of sensory block as well as side effects.
Spinal anesthesia has been linked to different adverse effects, out of which hypotension is most common complication. The incidence of hypotension is 25-75% in general population. Factors that increase the risk of hypotension include patient factors (advanced age, pregnancy, obesity, diabetes mellitus, hypertension, and anemia) and technical factors such as a block level at or above T5, use of opioids during premedication, and high local anesthetic dosages.
- Being tested
- Group A (hyperbaric bupivacaine), Group B (Mixture of Hyperbaric and Isobaric Bupivacaine)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A (hyperbaric bupivacaine)Drug
Patients were injected intrathecally with 20 mg hyperbaric bupivacaine 0.5% solution
Group B (Mixture of Hyperbaric and Isobaric Bupivacaine)Drug
Patients received 10 mg hyperbaric bupivacaine and 10 mg isobaric bupivacaine 0,5 % solution
| Study group | Role | What they receive |
|---|---|---|
| Group A (hyperbaric bupivacaine) | Experimental | Patients were injected intrathecally with 20 mg hyperbaric bupivacaine 0.5% solution. Receives: Drug: Group A (hyperbaric bupivacaine) |
| Group B (Mixture of Hyperbaric and Isobaric Bupivacaine) | Experimental | Patients received 10 mg hyperbaric bupivacaine and 10 mg isobaric bupivacaine 0,5 % solution. Receives: Drug: Group B (Mixture of Hyperbaric and Isobaric Bupivacaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypotension
Blood pressure was recorded using standard non-invasive monitors at 5, 10, 15, 20, 25, 30, 45, and 60 min, then hourly until 3 h post-injection.
Hypotension was defined as a decrease in mean arterial pressure of more than 30% from baseline.
Measured: 3 hours post-injection
Secondary outcomes (2)
Heart rate
Heart rate was recorded using standard non-invasive monitors at 5, 10, 15, 20, 25, 30, 45, and 60 min, then hourly until 3 h post-injection.
Measured: 3 hours post-injection
Mean arterial pressure (MAP)
Mean arterial pressure was recorded using standard non-invasive monitors at 5, 10, 15, 20, 25, 30, 45, and 60 min, then hourly until 3 h post-injection.
Measured: 3 hours post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 May 2022
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adel Ali Hassan, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050044
- Sponsor's protocol ID
- 48-2022
- Status last verified
- Sep 2023
- First submitted
- 17 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Injection of Hyperbaric Bupivacaine Versus a Mixture of Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Lower Abdominal Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06050044
- Acronym / sponsor ID
- 48-2022
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 22 Sep 2023 (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 aim of this study is to compare the effects of intrathecal injection of hyperbaric bupivacaine versus injection of hyperbaric and isobaric bupivacaine in patients undergoing lower abdominal surgery.
Detailed description
Spinal anesthesia is one of the most commonly used nerve block procedures for surgical operations involving the lower abdomen, the perineum, and the lower limbs, owing to its quick effect and cost-effectiveness. Spinal anesthesia is advantageous in that it uses a small dose of anesthesia, is simple to perform, and offers a rapid onset of action, reliable surgical analgesia, and good muscle relaxation.
The Baricity of a solution is defined as the ratio of the density of the solution to that of the cerebrospinal fluid (CSF). The most common anesthetic used for SA in obstetric and non-obstetric surgery is bupivacaine, which can be formulated as an isobaric or hyperbaric solution. Baricity differences between spinal anesthetic solutions are thought to affect hemodynamic parameters and distribution within the subarachnoid space, which may, in turn, affect the onset, extent, and duration of sensory block as well as side effects.
Spinal anesthesia has been linked to different adverse effects, out of which hypotension is most common complication. The incidence of hypotension is 25-75% in general population. Factors that increase the risk of hypotension include patient factors (advanced age, pregnancy, obesity, diabetes mellitus, hypertension, and anemia) and technical factors such as a block level at or above T5, use of opioids during premedication, and high local anesthetic dosages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (hyperbaric bupivacaine) | Experimental | Drug: Group A (hyperbaric bupivacaine)Patients were injected intrathecally with 20 mg hyperbaric bupivacaine 0.5% solution. |
| Group B (Mixture of Hyperbaric and Isobaric Bupivacaine) | Experimental | Drug: Group B (Mixture of Hyperbaric and Isobaric Bupivacaine)Patients received 10 mg hyperbaric bupivacaine and 10 mg isobaric bupivacaine 0,5 % solution. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18-65 years old.
- Both sexes.
- American Society of Anaesthesia (ASA) I to II.
- Undergoing lower abdominal or urological surgery under spinal anesthesia
Key exclusion criteria (5 listed)
- Allergy to amide.
- Patients with a significant history of substance abuse.
- Patients with diabetes mellitus, neurological or cardiovascular diseases.
- Patients with neuromuscular diseases.
- Pregnant patients.
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 |
|---|---|---|
| Group A (hyperbaric bupivacaine)Patients were injected intrathecally with 20 mg hyperbaric bupivacaine 0.5% solution | Drug | Group A (hyperbaric bupivacaine) |
| Group B (Mixture of Hyperbaric and Isobaric Bupivacaine)Patients received 10 mg hyperbaric bupivacaine and 10 mg isobaric bupivacaine 0,5 % solution | Drug | Group B (Mixture of Hyperbaric and Isobaric Bupivacaine) |
Primary outcome
Incidence of hypotension
Time frame: 3 hours post-injection
Blood pressure was recorded using standard non-invasive monitors at 5, 10, 15, 20, 25, 30, 45, and 60 min, then hourly until 3 h post-injection. Hypotension was defined as a decrease in mean arterial pressure of more than 30% from baseline.
2 secondary outcomes
Heart rate
Time frame: 3 hours post-injection
Mean arterial pressure (MAP)
Time frame: 3 hours post-injection
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 22 Sep 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Group A (hyperbaric bupivacaine) and Group B (Mixture of Hyperbaric and Isobaric Bupivacaine) in people with Spinal Anesthesia and Hyperbaric Bupivacaine, run by Helwan 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 5 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 22 Sep 2023. 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 hypotension (time frame: 3 hours post-injection). 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 22 Sep 2023.