Subarachnoid Bupivacaine in Obese Patients Undergoing Cesarean Delivery

December 19, 2019 updated by: MARIA DE LOS ANGELES CAMPECHANO ASCENCIO, Hospital Civil de Guadalajara

Effectiveness of Subarachnoid Hyperbaric Bupivacaine on Mean Arterial Blood Pressure in Pregnant Patients With Obesity Operated by Cesarean Section

This study evaluates the effect of subarachnoid hyperbaric bupivacaine on mean arterial blood pressure (MAP) of pregnant patients with obesity undergoing cesarean section half of the patients will receive subarachnoid hyperbaric bupivacaine at a dose of 5 mg while the other half will receive a dose of 10 mg

Study Overview

Status

Completed

Detailed Description

Once the patients were admitted to the toco-surgery work area, patients over 18 years of age were captured, with pregnancy ≥37 weeks of gestation, which, based on weight and height prior to pregnancy, obesity is diagnosed with a BMI ≥30 kg / m2 and that had an indication of termination of pregnancy via abdominal caesarean section without compromising fetal well-being. Specifically, the objectives of the study protocol, benefits and risks were given and it was given to choose an envelope containing the consent letter under information, the data collection sheet and the group to which it was assigned. He was granted the consent letter under information to sign; the same procedure was performed with the husband or relative responsible for the patient They underwent pre-anesthetic evaluation, background check and review of laboratory tests, as well as taking vital signs such as non-invasive blood pressure, mean blood pressure (PAM), O2 saturation and heart rate, Fetal heart rate was taken with adult stethoscope. The administration of Hartmann solution at 10ml /kg pregestational weight and premedication with ranitidine 50 mg and metoclopramide 10 mg was informed prior to admission to the operating room In the operating room, room preparation was carried out with material for anesthesiology corresponding laryngoscope, intubation cannulas, oropharyngeal cannulas, verification of operation of anesthesia machine, verification of material of blocking equipment, needles, syringes, alcohol and iodo povidone; Verify hyperbaric bupivacaine drugs, ephedrine and atropine. In case of requiring a change in anesthetic technique, general anesthesia have necessary fentanyl opioid drugs, propofol inducer and rocuronium muscle relaxant. Preparation of emergency drugs atropine and ephedrine dilution of 1 ampoule in 10 ml of diluent solution. The patient was transferred to the operating room, baseline vital signs were taken, non-invasive blood pressure, MAP, O2 saturation and heart rate with the monitor team Simultaneously fetal heart rate was taken Permeability of peripheral pathways was verified The patient was placed in a sitting position and started with mixed technique neuraxial anesthetic anesthetic technique (placement of peridural catheter + subarachnoid block with brand blocking equipment) The anatomical reference of the intervertebral space L2-L3, L3-L4 was located in a seated position. Aseptic and antiseptic technique was performed with iodo povidone, and subsequently removed with alcohol Sterile fields were placed Skin and subcutaneous tissue were infiltrated with 2% lidocaine 5 ml of the selected intervertebral space Tuohy needle No. 17 was introduced with the "Gout of Gutierrez" technique, until the location was found, it was corroborated with the "resistance loss" technique. Through the Tuohy needle, the spinal needle "whitacre" pencil No. 27 was introduced until cerebrospinal fluid (CSF) was obtained. The dose of hyperbaric bupivacaine blockade of 10 mg (2 ml) or mg (1 ml) was administered agreement with the assigned group, in approximately 20 seconds; the spinal needle pencil tip "whitacre" and an epidural catheter was introduced with cephalic direction and left 5 cm inside the epidural space, left inert. Catheter was attached to the back with adhesive tape The patient was placed in a dorsal recumbent position with a shifting wedge placement on the right hip approximately 15 degrees to the left. Vital signs monitoring was started every 3 minutes for the first 15 minutes and then every 5 minutes until the end of the anesthetic procedure When obtaining PAM record of less than 20% at baseline, ephedrine 10 mg is administered and total doses required were recorded until PAM records were recovered above 20% of baseline. Together with the record of the first taking of vital signs, the fetal heart rate was taken again After the second vital signs were taken, (3 minutes), a sensory block evaluation was started with a puncture technique from the dermatome where the block was placed and the ascending dermatome was registered where the patient reported pain. This assessment was performed every 3 minutes for the first 15 minutes, and then every 15 minutes until the end of the surgery. The blocking level was considered adequate to initiate the surgical procedure when the loss of sensitivity in the T4 dermatome was reached. After the second vital signs were taken (3 minutes), a motor block assessment with a Bromage scale was initiated, in which the patient was instructed to make movements with her legs to assess the capacity of movement that still remains. This assessment was performed every 3 minutes for the first 15 minutes, and then every 15 minutes until the end of the surgery After the second vital signs were taken (3 minutes), the patient was asked if she had a feeling of nausea or the presence of vomiting and was registered. At the extraction of the fetus, the Apgar assessment granted by the attached neonatology doctor at one minute and at 5 minutes of extrauterine life was recorded. Once the placenta was illuminated, a sample was taken for gasometry with a heparinized syringe of the umbilical artery and sent to the laboratory for processing. A dose of local anesthetic was administered via a 5% lidocaine 2% peridural catheter if necessary, when the patient reported discomfort or pain (referred to the decrease in sensory block) and the surgical procedure has not been completed. The time at which subsequent doses are administered is recorded The information collected was recorded on the data collection sheet. The presence of adverse reactions to drugs or the anesthetic technique were recorded in the adverse event sheets. The sample size was calculated with a formula for comparison of two means with finite population.

No results are found in previous publications with a statistically significant P, so a pilot test is carried out based on the specified criteria, which includes 30 patients, 15 patients in the group administered 5 mg of Subarachnoid hyperbaric bupivacaine and 15 patients in the group who were administered 10 mg of the same drug, and a standard deviation of 14.46 was obtained for the maximum blood hypotension variable recorded. For the development of the finite population formula, the total of anesthesiology procedures is quantified, the total of cesarean surgeries performed in the operating rooms of the toco-surgery of the Civil Hospital of Guadalajara Fray Antonio Alcalde in 2015; where a total of 1,218 caesarean sections are obtained y Calculated losses 25% pregnant women with obesity per group N = 40 patients. The statistical analysis was carried out once both study groups were completed. The groups were divided with the assignment codes to group 5 or 10. The database was formed in the Microsoft Office Excel 2013 program, which was exported to the statistical program Statistics Product and Service Solution (SPSS) version 22 in order to carry out the data analysis. All patients were included in the statistical analysis. The data obtained are expressed through measures of central tendency and dispersion, mean and standard deviation for quantitative variables, and frequencies and percentages in the case of qualitative variables. Due to the sample size, it is decided to use non-parametric tests for data analysis. The intra-group differences for the quantitative variables were determined by the Wilcoxon rank test, while the differences between the groups were determined with the Mann Whitney U test. Qualitative variables were analyzed through the Chi Square test. A value of p≤0.05 was considered statistically significant.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Hospital Civil de Guadalajara

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

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with single fetus pregnancy ≥37 weeks gestation
  • Body mass index (BMI) ≥ 30 kg / m2
  • Indication of termination of pregnancy via abdominal caesarean section
  • Indication of subarachnoid neuraxial block under mixed technique
  • Signing of consent under information

Exclusion Criteria:

  • Patients with a known allergy to local anesthetics
  • Patients with psychiatric treatment (antidepressants, anxiolytics, antipsychotics)
  • Patients with addiction to any type of drug
  • Patients with a history of liver disease
  • Patients with a history of renal pathology
  • Patients with a history of pulmonary pathology
  • Patients with a history of cardiac pathology
  • Patients with a history of high blood pressure
  • Patient with a history of type I, II and gestational diabetes
  • Non-calming fetal state
  • Patients who refuse the anesthetic technique of neuraxial block

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bupivacaine 5 mg
Receive subarachnoid hyperbaric bupivacaine at a dose of 5 mg
Receive subarachnoid hyperbaric bupivacaine at a dose of 5 mg
Other Names:
  • hyperbaric bupivacaine 1ml
  • bupivacaine/Dextrose 1ml
Experimental: Bupivacaine 10 mg
Receive subarachnoid hyperbaric bupivacaine at a dose of 10 mg
Receive subarachnoid hyperbaric bupivacaine at a dose of 10 mg
Other Names:
  • hyperbaric bupivacaine 2 ml
  • bupivacaine/Dextrose 1 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the mean blood pressure
Time Frame: 2 hours
Number of participants with a decrease in mean arterial blood pressure after administration of subarachnoid hyperbaric bupivacaine at a dose of 5 mg and 10 mg to preserve the mean blood pressure in pregnant patients with obesity undergoing caesarean section
2 hours
Determine the effects on the heart rate
Time Frame: 2 hour
Number of participants presenting changes in heart rate such as bradycardia (heart rate less than 60 beats minute) or tachycardia (heart rate greater than 120 beats minute) after administration of subarachnoid hyperbaric bupivacaine in the pregnant patients with obesity, after subarachnoid block
2 hour
Determine the effects on the respiratory rate
Time Frame: 2 hour
Number of participants presenting changes in respiratory rate such as bradypnea (respiratory rate less than 12 minute breaths) after administration of subarachnoid hyperbaric bupivacaine in the pregnant patient with obesity, after subarachnoid block
2 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the adverse effects
Time Frame: 2 hours
Number of participants with side effects such as nausea or vomiting after administration of subarachnoid hyperbaric bupivacaine in the pregnant patient with obesity, after subarachnoid block.
2 hours
Identify the level of sensory blockade
Time Frame: 15 minutes
The number of participants with adequate sensory block (thoracic dermatome 4 is defined as adequate to begin the surgical technique), the level of sensory block reached after the subarachnoid block; The sensory block was evaluated using pinprick. Every 3 minutes the first 15 minutes after the subarcnoid block.
15 minutes
Identify the intensity of motor blockade
Time Frame: 15 minutes
The number of participants with adequate intensity of motor blockade achieved after subarachnoid block, the intensity of the motor block was evaluated with the bromage scale (I Free movement of legs and feet. II Just able to flex Knees with free movement of feet, III Unable to flex knees, but with free movement of feet. IV Unable to move legs or feet) Level IV was considered adequate motor block. Every 3 minutes the first 15 minutes after the subarachnoid block.
15 minutes
Measure the duration of the block
Time Frame: 2 hour
Measure the duration of the block with a dose of 5 mg and 10 mg of hyperbaric bupivacaine via subarachnoid route in pregnant patients with obesity
2 hour
Describe the adverse effects on the fetus
Time Frame: 1 hour
The number of patients with any side effect associated with the fetal bradycardia anesthetic technique (Fetal heart rate less than 120 beats minute) cardiac arrest (Fetal heart rate less than 100 beats minute) And in the newborn fetal acidosis (umbilical vein gasometry with Hydrogen Potential (pH) <7.0 or excess bases >-12 mmol/L)
1 hour
Document the Apgar score
Time Frame: 5 minutes
Document the Apgar score in the newborn. (Apgar Score evaluate five sign: color, heart rate, reflex irritability, muscle tone and respiration) The score ranges from 0 to 2 per sign according to the criteria of the neonatologist, to grant a maximum score of 10 points. A grade of less than 7 points is considered low Apgar scores. This scores is registered t minute and five minutes of life.
5 minutes

Collaborators and Investigators

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

Investigators

  • Principal Investigator: María de los Angeles Campechano Ascencio, MSc, Hospital Civil de Guadalajara
  • Study Director: MIRIAM MENDEZ DEL VILLAR, MSc PhD, Centro Universitario de Tonalá
  • Study Chair: LEONEL GARCIA BENAVIDES, Hospital Civil de Guadalajara
  • Study Chair: JORGE BRAVO RUBIO, Hospital Civil de Guadalajara

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.

General Publications

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)

February 1, 2017

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

May 30, 2018

Study Registration Dates

First Submitted

December 7, 2019

First Submitted That Met QC Criteria

December 17, 2019

First Posted (Actual)

December 19, 2019

Study Record Updates

Last Update Posted (Actual)

December 23, 2019

Last Update Submitted That Met QC Criteria

December 19, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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