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

NCT06640816 | Completed DMC

• 1 other identifier: UJenderalSoedirman
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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

Conditions

Patients with ASA Physical Status 1 - 2 Who Undergo Surgical Delivery (cesarean Section)

Outcome Measures

Primary Outcomes (3)

• 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.

  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)

  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

  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)

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• \- Patient refuses to participate

Sponsors & Collaborators

• Universitas Jenderal Soedirman: lead

Related Publications (1)

• 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.

  PMID: 35755061 BACKGROUND

Related Links

• Related Info

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 15, 2024
• Study Start: January 1, 2015
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: October 15, 2024

Record last verified: 2024-09