Complications; Cesarean SectionNCT02635555
The Effects of Height and Weight Adjusted Dose of Local Anesthetic.
A study testing Phenylephrine in people with Complications; Cesarean Section and Hypotension, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
At our centre a conventional dose of 12 mg of hyperbaric bupivacaine in combination with a short acting opioid fentanyl (to increase block density) and a long acting opioid morphine (to provide post-operative pain relief ) is used for spinal anesthesia for cesarean section.However, larger doses of local anesthetic… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Complications; Cesarean Section, Hypotension
- What is being tested?
- Phenylephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to Dec 2019
- Phase
- Interventional
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I and II patients aged 18-40 > 37 weeks gestation
- Scheduled for an elective c-section under spinal anesthetic
- Singleton pregnancy
- Patients height between 150-180cm and with a BMI of <35
- Subject understands the study and consents to participate
Who cannot join
- Contraindication to neuraxial blockade
- Local anesthetic allergy
- Above or below our defined height and BMI criteria
- Emergency C-Section
- Complicated pregnancy including severe toxemia, pregnancy induced hypertension, and placenta previa
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Height and Weight Adjusted Dose of Local Anesthetic Compared to Standard Dose for Spinal Anesthesia in Elective Cesarean Section
At our centre a conventional dose of 12 mg of hyperbaric bupivacaine in combination with a short acting opioid fentanyl (to increase block density) and a long acting opioid morphine (to provide post-operative pain relief ) is used for spinal anesthesia for cesarean section.However, larger doses of local anesthetic drug when used in caesarean section commonly cause low blood pressure and requires drugs (vasopressors) to treat it. In our study the investigators will standardize the doses of both opioids (fentanyl/morphine) and adjust the dose of local anesthetic (bupivacaine) based on the patients height and weight .One of the obvious challenges anesthesiologists face is providing adequate anesthesia to the patient whilst minimizing harmful side effects. Our primary concern is the low blood pressure as an effect of the spinal anesthetic as it is harmful to both mother and the baby. The investigators propose that the extent of surgical anesthetic block, which is dependent on height and weight in our adjusted dose group, will provide adequate anesthesia for surgery and minimise maternal low blood pressure.
Read the detailed description
Study design is prospective, randomized, double blind, placebo controlled.
Patients presenting for elective cesarean section under neuraxial block and meeting inclusion criteria will be randomized to two groups:
Group 1: Fixed dose group: Bupivacaine 12 mg, Fentanyl 15 mcg, Morphine 100 mcg Group 2: Height and weight adjusted bupivacaine dose, fentanyl 15 mcg, morphine 100 mcg Patients are fasted as per Canadian guidelines prior to the procedure. All patients have an IV cannula inserted,baseline vitals recorded and routine blood work checked prior to blockade. Routine monitoring (as per Canadian Anesthesia Society (CAS) guidelines) occur during and after the procedure. This includes pulse oximetry (SpO2), ECG and non-invasive blood pressure (NIBP). NIBP monitoring occurs every two minutes for the first 20 minutes post spinal and every 5 minutes thereafter. Oxygen via Hudson mask or nasal prongs is available if required.
Spinal anesthetic is performed with standard doses of drugs and the level of sensory block is tested with ice. Motor block is tested with Bromage scale just before prepping and draping. Once deemed adequate, surgery begins. During surgery, phenylephrine/ephedrine is given to maintain blood pressure as necessary. After surgery, patients are monitored in a recovery area until fit to be transferred to their rooms. If patient reports extreme discomfort or sharp pain during the surgery,conversion to general anesthetic is as per the discretion of the attending anesthesiologist.
- Conditions
- Complications; Cesarean Section, Hypotension
- Being tested
- Phenylephrine
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
Also called Ephedrine
100 mcg of phenylephrine or 5 mg ephedrine given as deemed necessary for treating episodes of hypotension.
| Study group | Role | What they receive |
|---|---|---|
| Adjusted Spinal Dose | Experimental | Patients in this group receive height and weight adjusted dose for spinal anesthesia.During surgery, phenylephrine/ephedrine is given to maintain blood pressure as necessary.
Episodes of hypotension will be treated with these vasopressors . Receives: Drug: Phenylephrine |
| Standard Spinal Dose | Active comparator | Patients in this group receive a fixed standard dose for spinal anesthesia. During surgery, phenylephrine/ephedrine is given to maintain blood pressure as necessary.
Episodes of hypotension will be treated with these vasopressors . Receives: Drug: Phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal hypotension needing vasopressors.
Measured: Until the end of surgery
Secondary outcomes (3)
Time to adequate surgical anesthetic block
Measured: 24 hours after the surgery
incidence of nausea, vomiting, pruritus, and respiratory depression
Measured: 24 hours after the surgery
conversion to general anesthesia due to block failure
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startApr 2016
- Primary completionJun 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications; Cesarean SectionStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shalini Dhir, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Shalini Dhir, FRCPC, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635555
- Sponsor's protocol ID
- 107445
- Status last verified
- Sep 2022
- First submitted
- 10 Dec 2015
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Height and Weight Adjusted Dose of Local Anesthetic Compared to Standard Dose for Spinal Anesthesia in Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT02635555
- Acronym / sponsor ID
- 107445
- Conditions
- Complications; Cesarean Section, Hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 21 Dec 2015 (estimated)
- 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.
At our centre a conventional dose of 12 mg of hyperbaric bupivacaine in combination with a short acting opioid fentanyl (to increase block density) and a long acting opioid morphine (to provide post-operative pain relief ) is used for spinal anesthesia for cesarean section.However, larger doses of local anesthetic drug when used in caesarean section commonly cause low blood pressure and requires drugs (vasopressors) to treat it. In our study the investigators will standardize the doses of both opioids (fentanyl/morphine) and adjust the dose of local anesthetic (bupivacaine) based on the patients height and weight .One of the obvious challenges anesthesiologists face is providing adequate anesthesia to the patient whilst minimizing harmful side effects. Our primary concern is the low blood pressure as an effect of the spinal anesthetic as it is harmful to both mother and the baby. The investigators propose that the extent of surgical anesthetic block, which is dependent on height and weight in our adjusted dose group, will provide adequate anesthesia for surgery and minimise maternal low blood pressure.
Detailed description
Study design is prospective, randomized, double blind, placebo controlled.
Patients presenting for elective cesarean section under neuraxial block and meeting inclusion criteria will be randomized to two groups:
Group 1: Fixed dose group: Bupivacaine 12 mg, Fentanyl 15 mcg, Morphine 100 mcg Group 2: Height and weight adjusted bupivacaine dose, fentanyl 15 mcg, morphine 100 mcg Patients are fasted as per Canadian guidelines prior to the procedure. All patients have an IV cannula inserted,baseline vitals recorded and routine blood work checked prior to blockade. Routine monitoring (as per Canadian Anesthesia Society (CAS) guidelines) occur during and after the procedure. This includes pulse oximetry (SpO2), ECG and non-invasive blood pressure (NIBP). NIBP monitoring occurs every two minutes for the first 20 minutes post spinal and every 5 minutes thereafter. Oxygen via Hudson mask or nasal prongs is available if required.
Spinal anesthetic is performed with standard doses of drugs and the level of sensory block is tested with ice. Motor block is tested with Bromage scale just before prepping and draping. Once deemed adequate, surgery begins. During surgery, phenylephrine/ephedrine is given to maintain blood pressure as necessary. After surgery, patients are monitored in a recovery area until fit to be transferred to their rooms. If patient reports extreme discomfort or sharp pain during the surgery,conversion to general anesthetic is as per the discretion of the attending anesthesiologist.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjusted Spinal Dose | Experimental | Drug: PhenylephrinePatients in this group receive height and weight adjusted dose for spinal anesthesia.During surgery, phenylephrine/ephedrine is given to maintain blood pressure as necessary. Episodes of hypotension will be treated with these vasopressors . |
| Standard Spinal Dose | Active comparator | Drug: PhenylephrinePatients in this group receive a fixed standard dose for spinal anesthesia. During surgery, phenylephrine/ephedrine is given to maintain blood pressure as necessary. Episodes of hypotension will be treated with these vasopressors . |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ASA I and II patients aged 18-40 > 37 weeks gestation
- Scheduled for an elective c-section under spinal anesthetic
- Singleton pregnancy
- Patients height between 150-180cm and with a BMI of <35
- Subject understands the study and consents to participate
Key exclusion criteria (5 listed)
- Contraindication to neuraxial blockade
- Local anesthetic allergy
- Above or below our defined height and BMI criteria
- Emergency C-Section
- Complicated pregnancy including severe toxemia, pregnancy induced hypertension, and placenta previa
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 |
|---|---|---|
| PhenylephrineAlso: Ephedrine100 mcg of phenylephrine or 5 mg ephedrine given as deemed necessary for treating episodes of hypotension. | Drug | Adjusted Spinal Dose, Standard Spinal Dose |
Primary outcome
Maternal hypotension needing vasopressors.
Time frame: Until the end of surgery
3 secondary outcomes
Time to adequate surgical anesthetic block
Time frame: 24 hours after the surgery
incidence of nausea, vomiting, pruritus, and respiratory depression
Time frame: 24 hours after the surgery
conversion to general anesthesia due to block failure
Time frame: 1 hour
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 26 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Complications; Cesarean Section
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
Shalini Dhir, FRCPC principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenylephrine in people with Complications; Cesarean Section and Hypotension, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 5 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 26 Sep 2022. 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 Canada. 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.
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?
Maternal hypotension needing vasopressors. (time frame: Until the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2022.