Patients with ASA Physical Status 1 - 2 Who Undergo Surgical Delivery (cesarean Section)NCT06640816
Bupivacaine Effectivity and Efficiency for Regional Spinal Anesthesia in Non-ERACS and ERACS Caesarean Section
An observational study of Patients with ASA Physical Status 1 - 2 Who Undergo Surgical Delivery (cesarean Section), run by Universitas Jenderal Soedirman.
Trial summary
The most widely used regional anesthesia technique in Indonesia today is regional anesthesia with the subarachnoid (spinal) blockade method. In its development, this technique is not only used for surgery in the lower abdomen area, but also used as a management of acute pain. Read more about this study
- Who is it for?
- Ages 20 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patients with ASA Physical Status 1 - 2 Who Undergo Surgical Delivery (cesarean Section)
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 30 Dec 2023
- How long will I take part?
- 3 Days
- Phase
- Observational
- 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All pregnant patients who come to the hospital and undergo delivery operations
Who may be able to join
- Patient undergo sectio caesaria
- ASA 1-2 phisically state
Who cannot join
- Patient refuses to participate
About this study
Official title: Effectiveness & Efficiency of Bupivacaine Regional Spinal Anesthesia in Non-ERACS and ERACS Caesarean Section Based on Height and BMI
The most widely used regional anesthesia technique in Indonesia today is regional anesthesia with the subarachnoid (spinal) blockade method. In its development, this technique is not only used for surgery in the lower abdomen area, but also used as a management of acute pain. Especially for cases of pregnant patients undergoing cesarean section, in its development a method known as enhanced regional anesthesia for c-section (ERACS) emerged.
This technique is widely preferred by most patients. ERACS is considered very beneficial for patients, because this technique promises faster mobility after surgery with a longer duration of pain compared to conventional spinal regional anesthesia techniques.
Read more
The data collected from this study is secondary data derived from the medical records of patients in 2 private hospitals in Purbalingga Regency, which are taken and sorted systematically according to needs.
This study was conducted based on the situation and condition of health services in Indonesia which are highly dependent on state funding through the national health insurance system. The state funding emphasizes the effectiveness and efficiency of health services, including surgical and related procedures.
The question of this research :
- Is Bupivacaine in ERACS patients better than Non-ERACS based on BMI and height?
- Is Bupivacaine in ERACS patients more effective and efficient than Non-ERACS based on BMI and height?
Read the detailed description
This study was conducted at 2 hospitals in Purbalingga Regency and is a routine procedure carried out by researchers since 2015 and collected gradually from January to December 2023. The purpose of this study was to see the effectiveness and efficiency of several standard procedures carried out by the author for several years on post-spinal anesthesia complications and the duration of mobilization. In general, the effectiveness and efficiency of an action will lead to costs. This study was divided into 4 groups, namely the dose group based on height and weight with the ERACS method (A1), the dose group based on height and weight non-ERACS (A2), the dose group not based on height and weight with the ERACS method (K1), and the dose group not based on height and weight non-ERACS (K2). The total sample used was 150 which was divided into 2, namely 100 cases based on height and weight and 50 cases not based on height and weight. The sampling technique used the purposive sampling method. The study was conducted during January - December 2023.
This study compared the effectiveness between groups as seen from postoperative hemodynamics (blood pressure and pulse), duration of pain relief, and the use of perioperative resuscitation drugs (ephedrine) based on the patient\'s height and weight. In patients in groups A1 and A2, the administration of 0.5% bupivacaine is when the height is \> 150 cm, then the dose of bupivacaine is 10 mg and if the height is more than 160 cm, then the dose of bupivacaine is 15 mg. In groups K1 and K2, the administration of 0.5% bupivacaine is 20 mg. All statistical analyses were performed using IBM SPSS Statistics Software Version 20. The statistical tests used were the Wilcoxon Signed Ranks Test and the Kruskal Wallis Test adjusted to the needs and type of data. Data is considered significant if the p value is less than 0.05.
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index (BMI)
In Kg/ m2. BMI is an estimate of the ideal body weight for health. BMI does not measure body fat directly but is closely related to other measurements that measure body fat. BMI is calculated by dividing your weight in kilograms by the patients; height in square meters. BMI can be calculated using either metric or imperial (US) units. For imperial units, BMI is calculated by dividing your weight in pounds by your height in inches squared, then multiplying by 703.
Measured: Each patient's BMI is measured from the time they first come for antenatal care, until the patient goes home after giving birth (9 months)
Body weight
Patient body weight in kilogram (Kg)
Measured: Each patient's body weight is measured from the time they first come for antenatal care, until the patient goes home after giving birth (9 months)
Body height
Patient height in meters
Measured: Measurements are taken once during pregnancy and also taken together with other measurements (BMI and bodyweight). Patients measured from the time they first come for antenatal care, until the patient goes home after giving birth (9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Jan 2015
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients with ASA Physical Status 1 - 2 Who Undergo Surgical Delivery (cesarean Section)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 150 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Universitas Jenderal Soedirman
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MM Rudi Prihatno, Universitas Jenderal Soedirman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640816
- Sponsor's protocol ID
- UJenderalSoedirman
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This study uses secondary data in Indonesian hospitals
Publications
Huang Q, Wen G, Hai C, Zheng Z, Li Y, Huang Z, Huang B. A Height-Based Dosing Algorithm of Bupivacaine in Spinal Anesthesia for Decreasing Maternal Hypotension in Cesarean Section Without Prophylactic Fluid Preloading and Vasopressors: A Randomized-Controlled Non-Inferiority Trial. Front Med (Lausanne). 2022 Jun 10;9:858115. doi: 10.3389/fmed.2022.858115. eCollection 2022.
PubMed 35755061
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness & Efficiency of Bupivacaine Regional Spinal Anesthesia in Non-ERACS and ERACS Caesarean Section Based on Height and BMI
- ClinicalTrials.gov ID
- NCT06640816
- Acronym / sponsor ID
- UJenderalSoedirman
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Universitas Jenderal SoedirmanUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 15 Oct 2024 (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 most widely used regional anesthesia technique in Indonesia today is regional anesthesia with the subarachnoid (spinal) blockade method. In its development, this technique is not only used for surgery in the lower abdomen area, but also used as a management of acute pain. Especially for cases of pregnant patients undergoing cesarean section, in its development a method known as enhanced regional anesthesia for c-section (ERACS) emerged.
This technique is widely preferred by most patients. ERACS is considered very beneficial for patients, because this technique promises faster mobility after surgery with a longer duration of pain compared to conventional spinal regional anesthesia techniques.
The data collected from this study is secondary data derived from the medical records of patients in 2 private hospitals in Purbalingga Regency, which are taken and sorted systematically according to needs.
This study was conducted based on the situation and condition of health services in Indonesia which are highly dependent on state funding through the national health insurance system. The state funding emphasizes the effectiveness and efficiency of health services, including surgical and related procedures.
The question of this research :
- Is Bupivacaine in ERACS patients better than Non-ERACS based on BMI and height?
- Is Bupivacaine in ERACS patients more effective and efficient than Non-ERACS based on BMI and height?
Detailed description
This study was conducted at 2 hospitals in Purbalingga Regency and is a routine procedure carried out by researchers since 2015 and collected gradually from January to December 2023. The purpose of this study was to see the effectiveness and efficiency of several standard procedures carried out by the author for several years on post-spinal anesthesia complications and the duration of mobilization. In general, the effectiveness and efficiency of an action will lead to costs. This study was divided into 4 groups, namely the dose group based on height and weight with the ERACS method (A1), the dose group based on height and weight non-ERACS (A2), the dose group not based on height and weight with the ERACS method (K1), and the dose group not based on height and weight non-ERACS (K2). The total sample used was 150 which was divided into 2, namely 100 cases based on height and weight and 50 cases not based on height and weight. The sampling technique used the purposive sampling method. The study was conducted during January - December 2023.
This study compared the effectiveness between groups as seen from postoperative hemodynamics (blood pressure and pulse), duration of pain relief, and the use of perioperative resuscitation drugs (ephedrine) based on the patient\'s height and weight. In patients in groups A1 and A2, the administration of 0.5% bupivacaine is when the height is \> 150 cm, then the dose of bupivacaine is 10 mg and if the height is more than 160 cm, then the dose of bupivacaine is 15 mg. In groups K1 and K2, the administration of 0.5% bupivacaine is 20 mg. All statistical analyses were performed using IBM SPSS Statistics Software Version 20. The statistical tests used were the Wilcoxon Signed Ranks Test and the Kruskal Wallis Test adjusted to the needs and type of data. Data is considered significant if the p value is less than 0.05.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 3 Days
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All pregnant patients who come to the hospital and undergo delivery operations
Key inclusion criteria (2 listed)
- Patient undergo sectio caesaria
- ASA 1-2 phisically state
Key exclusion criteria (1 listed)
- Patient refuses to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body mass index (BMI)
Time frame: Each patient's BMI is measured from the time they first come for antenatal care, until the patient goes home after giving birth (9 months)
In Kg/ m2. BMI is an estimate of the ideal body weight for health. BMI does not measure body fat directly but is closely related to other measurements that measure body fat. BMI is calculated by dividing your weight in kilograms by the patients; height in square meters. BMI can be calculated using either metric or imperial (US) units. For imperial units, BMI is calculated by dividing your weight in pounds by your height in inches squared, then multiplying by 703.
Body weight
Time frame: Each patient's body weight is measured from the time they first come for antenatal care, until the patient goes home after giving birth (9 months)
Patient body weight in kilogram (Kg)
Body height
Time frame: Measurements are taken once during pregnancy and also taken together with other measurements (BMI and bodyweight). Patients measured from the time they first come for antenatal care, until the patient goes home after giving birth (9 months)
Patient height in meters
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 Oct 2024.
- Background: PubMed 35755061Huang Q, Wen G, Hai C, Zheng Z, Li Y, Huang Z, Huang B. A Height-Based Dosing Algorithm of Bupivacaine in Spinal Anesthesia for Decreasing Maternal Hypotension in Cesarean Section Without Prophylactic Fluid Preloading and Vasopressors: A Randomized-Controlled Non-Inferiority Trial. Front Med (Lausanne). 2022 Jun 10;9:858115. doi: 10.3389/fmed.2022.858115. eCollection 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. This study uses secondary data in Indonesian hospitals
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients with ASA Physical Status 1 - 2 Who Undergo Surgical Delivery (cesarean Section), run by Universitas Jenderal Soedirman.
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 2 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Body mass index (BMI) (time frame: Each patient's BMI is measured from the time they first come for antenatal care, until the patient goes home after giving birth (9 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06640816, which also lists 1 linked publication.
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 Oct 2024.