Bupivacaine Effectivity and Efficiency for Regional Spinal Anesthesia in Non-ERACS and ERACS Caesarean Section

October 11, 2024 updated by: MM Rudi Prihatno, Universitas Jenderal Soedirman

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.

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 :

  1. Is Bupivacaine in ERACS patients better than Non-ERACS based on BMI and height?
  2. Is Bupivacaine in ERACS patients more effective and efficient than Non-ERACS based on BMI and height?

Study Overview

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 Type

Observational

Enrollment (Actual)

150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All pregnant patients who come to the hospital and undergo delivery operations

Description

Inclusion Criteria:

  • Patient undergo sectio caesaria
  • ASA 1-2 phisically state

Exclusion Criteria:

- Patient refuses to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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)
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
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
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

September 25, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 11, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • UJenderalSoedirman

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

This study uses secondary data in Indonesian hospitals

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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