Anesthesia, SpinalNCT05091294
The Effect of Injection Rate of Local Anesthetic in Caesarean Section
A study testing Local anesthetic injection rate in spinal anesthesia in people with Anesthesia, Spinal and Anesthesia, Obstetrical, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
This randomized double-blind study aimed to compare the effects of two different subaracnoid lokal anesthetic injection rate in cesarean section. Totally 67 patients were included. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Spinal, Anesthesia, Obstetrical
- What is being tested?
- Local anesthetic injection rate in spinal anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Feb 2020to 30 Jul 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Anesthesiologists risk score (ASA) I-II risk status
- Singleton pregnancy aged
- Between 18-40 years
Who cannot join
- Pregnant women with contraindications for spinal anesthesia;
- Placental anomaly;
- Hypertension
- Cardiac disease
- Vascular disease
- Hepatic disease
Show all 13Show fewer
- Renal disease
- Hemodynamic instability
- Spinal deformity;
- Severe mental retardation
- Weight < 50 kg or >110 kg; height < 140 cm or > 180 cm
- Metabolic and Acid-base balance disorders
- Emergency patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Injection Rate of Local Anesthetic Affect the Onset of Sensory Block and Incidence of Hypotension in Caesarean Section
This randomized double-blind study aimed to compare the effects of two different subaracnoid lokal anesthetic injection rate in cesarean section. Totally 67 patients were included. The groups were compared in terms of maximum sensory and motor block level, time to reach T6 level, hemodynamic changes and nausea- vomiting saved.
Read the detailed description
A total of 67 patients 18-40 years undergoing cesarean, who were graded as American Society of Anesthesiologists physical status were randomly allocated into two groups, 120-sn injection time (n=34, Group F), 15-sn injection time (n=33, Group S). When the level of the sensory block achieve the T6 level the surgery was let to begin. The groups were compared in terms of hemodynamic values, use of efedrin, the time to achieve sensory block to the T6 level, maximum sensory block level and motor block level.
- Conditions
- Anesthesia, Spinal, Anesthesia, Obstetrical
- Being tested
- Local anesthetic injection rate in spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anesthetic injection rate in spinal anesthesiaOther
Administering intrathecal local anesthetics for all patients according to height and weight.
| Study group | Role | What they receive |
|---|---|---|
| Group S:33 | Active comparator | 120-second local anesthesic (% 0,5 Bupivacaine) injection time Receives: Other: Local anesthetic injection rate in spinal anesthesia |
| Group F:34 | Active comparator | 15-second local anesthesic(% 0,5 Bupivacaine) injection time Receives: Other: Local anesthetic injection rate in spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensory block
The time to reach the sufficient sensory block and maximum level of sensory block was significantly shorter in Group S
Measured: 2 minutes interval
Hypotension
The time to onset of hypotension was significantly shorter in Group F
Measured: 2 minutes interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start11 Feb 2020
- Primary completion25 Jan 2021
- Study completion30 Jul 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ersagun Tugcugil, Karadeniz Technical University
- Investigators
- Ersagun tugcugil, Principal investigator, KARADENİZ TEKNİK ÜNİVERSİTESİ DEPARTMENT OF ANESTHESİOLOGİA AND REANİMATİON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091294
- Sponsor's protocol ID
- 2020-52
- Other IDs
- Ahmet Beşir
- Status last verified
- Jan 2022
- First submitted
- 12 Oct 2021
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Injection Rate of Local Anesthetic Affect the Onset of Sensory Block and Incidence of Hypotension in Caesarean Section
- ClinicalTrials.gov ID
- NCT05091294
- Acronym / sponsor ID
- 2020-52
- Conditions
- Anesthesia, Spinal, Anesthesia, Obstetrical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 25 Jan 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 25 Oct 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.
This randomized double-blind study aimed to compare the effects of two different subaracnoid lokal anesthetic injection rate in cesarean section. Totally 67 patients were included. The groups were compared in terms of maximum sensory and motor block level, time to reach T6 level, hemodynamic changes and nausea- vomiting saved.
Detailed description
A total of 67 patients 18-40 years undergoing cesarean, who were graded as American Society of Anesthesiologists physical status were randomly allocated into two groups, 120-sn injection time (n=34, Group F), 15-sn injection time (n=33, Group S). When the level of the sensory block achieve the T6 level the surgery was let to begin. The groups were compared in terms of hemodynamic values, use of efedrin, the time to achieve sensory block to the T6 level, maximum sensory block level and motor block level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S:33 | Active comparator | Other: Local anesthetic injection rate in spinal anesthesia120-second local anesthesic (% 0,5 Bupivacaine) injection time |
| Group F:34 | Active comparator | Other: Local anesthetic injection rate in spinal anesthesia15-second local anesthesic(% 0,5 Bupivacaine) injection time |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Anesthesiologists risk score (ASA) I-II risk status
- Singleton pregnancy aged
- Between 18-40 years
Key exclusion criteria (13 listed)
- Pregnant women with contraindications for spinal anesthesia;
- Placental anomaly;
- Hypertension
- Cardiac disease
- Vascular 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 |
|---|---|---|
| Local anesthetic injection rate in spinal anesthesiaAdministering intrathecal local anesthetics for all patients according to height and weight. | Other | Group F:34, Group S:33 |
Primary outcome
sensory block
Time frame: 2 minutes interval
The time to reach the sufficient sensory block and maximum level of sensory block was significantly shorter in Group S
Hypotension
Time frame: 2 minutes interval
The time to onset of hypotension was significantly shorter in Group F
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 4 Feb 2022.
- 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.
Ersagun tugcugil principal investigator
KARADENİZ TEKNİK ÜNİVERSİTESİ DEPARTMENT OF ANESTHESİOLOGİA AND REANİMATİON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local anesthetic injection rate in spinal anesthesia in people with Anesthesia, Spinal and Anesthesia, Obstetrical, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
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 13 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 4 Feb 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 Turkey (Türkiye). 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?
sensory block (time frame: 2 minutes interval). 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 4 Feb 2022.