Anesthesia, ObstetricalPhase 4NCT04205344
Subarachnoid Bupivacaine in Obese Patients Undergoing Cesarean Delivery
A Phase 4 study testing Bupivacaine 5 mg and Bupivacaine 10 mg in people with Anesthesia, Obstetrical, run by Hospital Civil de Guadalajara at 1 site in Mexico.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Anesthesia, Obstetrical
- What is being tested?
- Bupivacaine 5 mg and Bupivacaine 10 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 1 Feb 2017to 30 May 2018
- Phase
- Phase 4
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Anesthesia, Obstetrical
- Being tested
- Bupivacaine 5 mg, Bupivacaine 10 mg
- Keywords
- Bupivacaine, Obesity, Pregnant, Subarachnoid, Cesarean, Subdural
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 5 mgDrug
Also called hyperbaric bupivacaine 1ml, bupivacaine/Dextrose 1ml
Receive subarachnoid hyperbaric bupivacaine at a dose of 5 mg
Bupivacaine 10 mgDrug
Also called hyperbaric bupivacaine 2 ml, bupivacaine/Dextrose 1 ml
Receive subarachnoid hyperbaric bupivacaine at a dose of 10 mg
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine 5 mg | Experimental | Receive subarachnoid hyperbaric bupivacaine at a dose of 5 mg Receives: Drug: Bupivacaine 5 mg |
| Bupivacaine 10 mg | Experimental | Receive subarachnoid hyperbaric bupivacaine at a dose of 10 mg Receives: Drug: Bupivacaine 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the mean blood pressure
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
Measured: 2 hours
Determine the effects on the heart rate
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
Measured: 2 hour
Determine the effects on the respiratory rate
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
Measured: 2 hour
Secondary outcomes (6)
Describe the adverse effects
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.
Measured: 2 hours
Identify the level of sensory blockade
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.
Measured: 15 minutes
Identify the intensity of motor blockade
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.
Measured: 15 minutes
Measure the duration of the block
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
Measured: 2 hour
Describe the adverse effects on the fetus
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)
Measured: 1 hour
Document the Apgar score
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start1 Feb 2017
- Primary completion30 Jun 2017
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, ObstetricalStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical trial open controlled parallel randomized simple
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Civil de Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARIA DE LOS ANGELES CAMPECHANO ASCENCIO, Hospital Civil de Guadalajara
- Investigators
- MARIA DE LOS ANGELES CAMPECHANO ASCENCIO, MSc, Principal investigator, Hospital Civil de GuadalajaraMIRIAM MENDEZ DEL VILLAR, MSc PhD, Study director, CENTRO UNIVERSITARIO DE TONALALEONEL GARCIA BENAVIDES, Study chair, Hospital Civil de GuadalajaraJORGE BRAVO RUBIO, Study chair, Hospital Civil de Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205344
- Sponsor's protocol ID
- 005/16
- Status last verified
- Dec 2019
- First submitted
- 7 Dec 2019
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Teoh WH, Thomas E, Tan HM. Ultra-low dose combined spinal-epidural anesthesia with intrathecal bupivacaine 3.75 mg for cesarean delivery: a randomized controlled trial. Int J Obstet Anesth. 2006 Oct;15(4):273-8. doi: 10.1016/j.ijoa.2006.03.004. Epub 2006 Jun 13.
PubMed 16774830Tonidandel A, Booth J, D'Angelo R, Harris L, Tonidandel S. Anesthetic and obstetric outcomes in morbidly obese parturients: a 20-year follow-up retrospective cohort study. Int J Obstet Anesth. 2014 Nov;23(4):357-64. doi: 10.1016/j.ijoa.2014.05.004. Epub 2014 Jun 4.
PubMed 25201313Ouzounian JG, Elkayam U. Physiologic changes during normal pregnancy and delivery. Cardiol Clin. 2012 Aug;30(3):317-29. doi: 10.1016/j.ccl.2012.05.004. Epub 2012 Jun 20.
PubMed 22813360Hood DD, Dewan DM. Anesthetic and obstetric outcome in morbidly obese parturients. Anesthesiology. 1993 Dec;79(6):1210-8. doi: 10.1097/00000542-199312000-00011.
PubMed 8267196Tan T, Sia AT. Anesthesia considerations in the obese gravida. Semin Perinatol. 2011 Dec;35(6):350-5. doi: 10.1053/j.semperi.2011.05.021.
PubMed 22108086Ngan Kee WD, Khaw KS, Tan PE, Ng FF, Karmakar MK. Placental transfer and fetal metabolic effects of phenylephrine and ephedrine during spinal anesthesia for cesarean delivery. Anesthesiology. 2009 Sep;111(3):506-12. doi: 10.1097/ALN.0b013e3181b160a3.
PubMed 19672175Lee Y, Balki M, Parkes R, Carvalho JC. Dose requirement of intrathecal bupivacaine for cesarean delivery is similar in obese and normal weight women. Rev Bras Anestesiol. 2009 Nov-Dec;59(6):674-83. doi: 10.1016/s0034-7094(09)70092-3. English, Portuguese.
PubMed 20011857Carvalho B, Collins J, Drover DR, Atkinson Ralls L, Riley ET. ED(50) and ED(95) of intrathecal bupivacaine in morbidly obese patients undergoing cesarean delivery. Anesthesiology. 2011 Mar;114(3):529-35. doi: 10.1097/ALN.0b013e318209a92d.
PubMed 21307769Ring LE. The anesthetic approach to operative delivery of the extremely obese parturient. Semin Perinatol. 2014 Oct;38(6):341-8. doi: 10.1053/j.semperi.2014.07.008. Epub 2014 Aug 19.
PubMed 25146109Badve MH, Golfeiz C, Vallejo MC. Anesthetic considerations for the morbid obese parturient. Int Anesthesiol Clin. 2014 Summer;52(3):132-47. doi: 10.1097/AIA.0000000000000024. No abstract available.
PubMed 24946047Lamon AM, Habib AS. Managing anesthesia for cesarean section in obese patients: current perspectives. Local Reg Anesth. 2016 Aug 16;9:45-57. doi: 10.2147/LRA.S64279. eCollection 2016.
PubMed 27574464Dennis AT, Castro JM, Ong M, Carr C. Haemodynamics in obese pregnant women. Int J Obstet Anesth. 2012 Apr;21(2):129-34. doi: 10.1016/j.ijoa.2011.11.007. Epub 2012 Feb 11.
PubMed 22326199Rodrigues FR, Brandao MJ. Regional anesthesia for cesarean section in obese pregnant women: a retrospective study. Rev Bras Anestesiol. 2011 Jan-Feb;61(1):13-20. doi: 10.1016/S0034-7094(11)70002-2.
PubMed 21334503Wise RA, Polito AJ, Krishnan V. Respiratory physiologic changes in pregnancy. Immunol Allergy Clin North Am. 2006 Feb;26(1):1-12. doi: 10.1016/j.iac.2005.10.004.
PubMed 16443140Chandra S, Tripathi AK, Mishra S, Amzarul M, Vaish AK. Physiological changes in hematological parameters during pregnancy. Indian J Hematol Blood Transfus. 2012 Sep;28(3):144-6. doi: 10.1007/s12288-012-0175-6. Epub 2012 Jul 15.
PubMed 23997449
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Subarachnoid Hyperbaric Bupivacaine on Mean Arterial Blood Pressure in Pregnant Patients With Obesity Operated by Cesarean Section
- ClinicalTrials.gov ID
- NCT04205344
- Acronym / sponsor ID
- 005/16
- Conditions
- Anesthesia, Obstetrical
- Keywords
- Bupivacaine, Obesity, Pregnant, Subarachnoid, Cesarean, Subdural
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital Civil de GuadalajaraUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 19 Dec 2019 (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 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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Clinical trial open controlled parallel randomized simple
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine 5 mg | Experimental | Drug: Bupivacaine 5 mgReceive subarachnoid hyperbaric bupivacaine at a dose of 5 mg |
| Bupivacaine 10 mg | Experimental | Drug: Bupivacaine 10 mgReceive subarachnoid hyperbaric bupivacaine at a dose of 10 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Bupivacaine 5 mgAlso: hyperbaric bupivacaine 1ml, bupivacaine/Dextrose 1mlReceive subarachnoid hyperbaric bupivacaine at a dose of 5 mg | Drug | Bupivacaine 5 mg |
| Bupivacaine 10 mgAlso: hyperbaric bupivacaine 2 ml, bupivacaine/Dextrose 1 mlReceive subarachnoid hyperbaric bupivacaine at a dose of 10 mg | Drug | Bupivacaine 10 mg |
Primary outcome
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
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
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
6 secondary outcomes
Describe the adverse effects
Time frame: 2 hours
Identify the level of sensory blockade
Time frame: 15 minutes
Identify the intensity of motor blockade
Time frame: 15 minutes
Measure the duration of the block
Time frame: 2 hour
Describe the adverse effects on the fetus
Time frame: 1 hour
Document the Apgar score
Time frame: 5 minutes
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 23 Dec 2019.
- Background: PubMed 16774830Teoh WH, Thomas E, Tan HM. Ultra-low dose combined spinal-epidural anesthesia with intrathecal bupivacaine 3.75 mg for cesarean delivery: a randomized controlled trial. Int J Obstet Anesth. 2006 Oct;15(4):273-8. doi: 10.1016/j.ijoa.2006.03.004. Epub 2006 Jun 13.
- Results publication: PubMed 25201313Tonidandel A, Booth J, D'Angelo R, Harris L, Tonidandel S. Anesthetic and obstetric outcomes in morbidly obese parturients: a 20-year follow-up retrospective cohort study. Int J Obstet Anesth. 2014 Nov;23(4):357-64. doi: 10.1016/j.ijoa.2014.05.004. Epub 2014 Jun 4.
- Results publication: PubMed 22813360Ouzounian JG, Elkayam U. Physiologic changes during normal pregnancy and delivery. Cardiol Clin. 2012 Aug;30(3):317-29. doi: 10.1016/j.ccl.2012.05.004. Epub 2012 Jun 20.
- Results publication: PubMed 8267196Hood DD, Dewan DM. Anesthetic and obstetric outcome in morbidly obese parturients. Anesthesiology. 1993 Dec;79(6):1210-8. doi: 10.1097/00000542-199312000-00011.
- Results publication: PubMed 22108086Tan T, Sia AT. Anesthesia considerations in the obese gravida. Semin Perinatol. 2011 Dec;35(6):350-5. doi: 10.1053/j.semperi.2011.05.021.
- Results publication: PubMed 19672175Ngan Kee WD, Khaw KS, Tan PE, Ng FF, Karmakar MK. Placental transfer and fetal metabolic effects of phenylephrine and ephedrine during spinal anesthesia for cesarean delivery. Anesthesiology. 2009 Sep;111(3):506-12. doi: 10.1097/ALN.0b013e3181b160a3.
- Results publication: PubMed 20011857Lee Y, Balki M, Parkes R, Carvalho JC. Dose requirement of intrathecal bupivacaine for cesarean delivery is similar in obese and normal weight women. Rev Bras Anestesiol. 2009 Nov-Dec;59(6):674-83. doi: 10.1016/s0034-7094(09)70092-3. English, Portuguese.
- Results publication: PubMed 21307769Carvalho B, Collins J, Drover DR, Atkinson Ralls L, Riley ET. ED(50) and ED(95) of intrathecal bupivacaine in morbidly obese patients undergoing cesarean delivery. Anesthesiology. 2011 Mar;114(3):529-35. doi: 10.1097/ALN.0b013e318209a92d.
- Results publication: PubMed 25146109Ring LE. The anesthetic approach to operative delivery of the extremely obese parturient. Semin Perinatol. 2014 Oct;38(6):341-8. doi: 10.1053/j.semperi.2014.07.008. Epub 2014 Aug 19.
- Results publication: PubMed 24946047Badve MH, Golfeiz C, Vallejo MC. Anesthetic considerations for the morbid obese parturient. Int Anesthesiol Clin. 2014 Summer;52(3):132-47. doi: 10.1097/AIA.0000000000000024. No abstract available.
- Results publication: PubMed 27574464Lamon AM, Habib AS. Managing anesthesia for cesarean section in obese patients: current perspectives. Local Reg Anesth. 2016 Aug 16;9:45-57. doi: 10.2147/LRA.S64279. eCollection 2016.
- Results publication: PubMed 22326199Dennis AT, Castro JM, Ong M, Carr C. Haemodynamics in obese pregnant women. Int J Obstet Anesth. 2012 Apr;21(2):129-34. doi: 10.1016/j.ijoa.2011.11.007. Epub 2012 Feb 11.
- Legislative powerLink provided by the sponsor.
- World Health Organization. Obesity and Overweight Descriptive Note No. 311Link provided by the sponsor.
- 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.
MARIA DE LOS ANGELES CAMPECHANO ASCENCIO, MSc principal investigator
Hospital Civil de Guadalajara
MIRIAM MENDEZ DEL VILLAR, MSc PhD study director
CENTRO UNIVERSITARIO DE TONALA
LEONEL GARCIA BENAVIDES study chair
Hospital Civil de Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine 5 mg and Bupivacaine 10 mg in people with Anesthesia, Obstetrical, run by Hospital Civil de Guadalajara at 1 site in Mexico.
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 5 inclusion and 11 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 23 Dec 2019. 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 Mexico. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Assess the mean blood pressure (time frame: 2 hours). 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 NCT04205344, which also lists 31 linked publications.
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 23 Dec 2019.