PainNCT00403663
Effect of Body Mass Index on the Dose of Intrathecal Hyperbaric Bupivacaine for Elective Cesarean Section
A study testing bupivacaine 0.75% with fentanyl and morphine in people with Pain and Obesity, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
Combined spinal - epidural (CSE) anesthesia is a well established technique used for elective Cesarean section. As its name suggests, it combines two anesthesia techniques - spinal and epidural. Adjusting the dose of freezing medication for body size is not as simple as giving a larger dose to a larger person. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- What is being tested?
- bupivacaine 0.75% with fentanyl and morphine
- Type of treatment
- Injection or infusion
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2006to Dec 2007
- 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
- Obese group: All pregnant women at term (over 37 weeks) scheduled for elective Cesarean section, with pre-pregnancy BMI greater than 30
- Normal weight group: All pregnant women at term (over 37 weeks) scheduled for elective Cesarean section, with pre-pregnancy BMI less than 25.
Who cannot join
- Patient's refusal.
- Patients with any absolute or relative contraindication for spinal/epidural anesthesia.
- Patients with BMI between 25 and 30.
- Patients with more than one fetus.
- Patients unable to communicate in English effectively.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Body Mass Index on the ED95 of Intrathecal Hyperbaric Bupivacaine for Elective Cesarean Section
Combined spinal - epidural (CSE) anesthesia is a well established technique used for elective Cesarean section. As its name suggests, it combines two anesthesia techniques - spinal and epidural. Adjusting the dose of freezing medication for body size is not as simple as giving a larger dose to a larger person. This study asks a simple, yet important question: does your body mass index (BMI) influence the amount of freezing medication needed for adequate CSE anesthesia for Cesarean section? BMI is a number calculated from your height and weight. In patients with a higher BMI, freezing medication appears to spread farther (to a higher level) in the spinal fluid. When freezing is too high, it can cause unwanted side effects. Therefore, in order to provide optimal spinal anesthesia to patients with a higher BMI, it may be advisable to administer less freezing medication. In this study, we want to find the ideal dose of freezing medication for patients with a higher body mass index, and compare it to the dose found to be ideal for patients with normal body mass index.
Read the detailed description
Spinal anesthesia is the most common anesthetic technique used for Cesarean section. It offers many advantages over epidural and general anesthesia. However, one of the limitations of spinal anesthesia in Obstetrics is the use of a single shot technique as the continuous technique is associated with unacceptable incidence of PDPH. It is difficult to predict the exact level of sensory block because many factors affect the spread of local anesthetic injected into the CSF. Theoretically, obese patients may have greater intra-abdominal pressure, leading to compression of the inferior vena cava and engorgement of the epidural venous plexus, which in turn increases the pressure inside the epidural space. This augmented pressure is transmitted to the dural sac and diverge the CSF from the lumbosacral region, leading to a decrease in CSF volume. It has been demonstrated that the volume of CSF in lumbosacral region is an important factor affecting intrathecal spread of anesthetics.
Our hypothesis is that obese women require less intrathecal hyperbaric bupivacaine than do normal weight women to achieve satisfactory surgical anesthesia for elective Cesarean section.Two groups of patients will be studied separately. Patients with BMI greater than or equal to 30 will be included in the obese group, also denominated study group. Patients with BMI less than 25 will be included in the normal weight group, also denominated control group. BMI will be calculated based on the patient's pre-pregnancy weight. For each group, the up-down sequential allocation method based on the Narayana rule will be used to find the minimum effective dose of intrathecal hyperbaric bupivacaine 0.75% associated with opioids necessary for satisfactory outcome in 95% of the pregnant women undergoing cesarean section, i.e. ED95.
There are two possible outcomes in our study: a satisfactory outcome is defined if the sensory block reaches at least at T6 and the patient does not complain of any pain or discomfort that requires intraoperative supplemental drugs; an unsatisfactory outcome is defined if the sensory block reaches a level lower than T6 or the patient complains of pain or discomfort that requires intraoperative supplemental drugs. The decision whether or not the supplementation is required will be made exclusively by the patient, and not by the physician in charge.
- Being tested
- bupivacaine 0.75% with fentanyl and morphine
- Keywords
- Body mass index, Combined Spinal-Epidural Anesthesia, Cesarean section, Obesity
- Medical subject headings
- Pain, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaine 0.75% with fentanyl and morphineDrug
the following administered once, by spinal injection; 9-12 mg 0.75% hyperbaric bupivacaine 10 mcg fentanyl 100 mcg morphine
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the success/failure of the block. Success meaning a sensory block level at least at T6 within 15 minutes after intrathecal injection and no requirement of any supplemental analgesic by the patient throughout the CS.
Measured: 15 minutes
Secondary outcomes (5)
Upper level of sensory blockage determined by the pinprick at midaxillary line
Measured: 60 minutes
VAPS during surgery
Measured: 60 minutes
Dose of lidocaine 2% required as supplementation
Measured: 60 minutes
Dose of IV fentanyl or ketamine required as supplementation
Measured: 60 minutes
Conversion to general anesthesia
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jose CA Carvalho, MD PhD, Principal investigator, Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403663
- Sponsor's protocol ID
- 06-02
- Other IDs
- 06-0206-E
- Status last verified
- Jul 2009
- First submitted
- 23 Nov 2006
- Last updated
- 30 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Body Mass Index on the ED95 of Intrathecal Hyperbaric Bupivacaine for Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT00403663
- Acronym / sponsor ID
- 06-02
- Keywords
- Body mass index, Combined Spinal-Epidural Anesthesia, Cesarean section, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 27 Nov 2006 (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.
Combined spinal - epidural (CSE) anesthesia is a well established technique used for elective Cesarean section. As its name suggests, it combines two anesthesia techniques - spinal and epidural. Adjusting the dose of freezing medication for body size is not as simple as giving a larger dose to a larger person. This study asks a simple, yet important question: does your body mass index (BMI) influence the amount of freezing medication needed for adequate CSE anesthesia for Cesarean section? BMI is a number calculated from your height and weight. In patients with a higher BMI, freezing medication appears to spread farther (to a higher level) in the spinal fluid. When freezing is too high, it can cause unwanted side effects. Therefore, in order to provide optimal spinal anesthesia to patients with a higher BMI, it may be advisable to administer less freezing medication. In this study, we want to find the ideal dose of freezing medication for patients with a higher body mass index, and compare it to the dose found to be ideal for patients with normal body mass index.
Detailed description
Spinal anesthesia is the most common anesthetic technique used for Cesarean section. It offers many advantages over epidural and general anesthesia. However, one of the limitations of spinal anesthesia in Obstetrics is the use of a single shot technique as the continuous technique is associated with unacceptable incidence of PDPH. It is difficult to predict the exact level of sensory block because many factors affect the spread of local anesthetic injected into the CSF. Theoretically, obese patients may have greater intra-abdominal pressure, leading to compression of the inferior vena cava and engorgement of the epidural venous plexus, which in turn increases the pressure inside the epidural space. This augmented pressure is transmitted to the dural sac and diverge the CSF from the lumbosacral region, leading to a decrease in CSF volume. It has been demonstrated that the volume of CSF in lumbosacral region is an important factor affecting intrathecal spread of anesthetics.
Our hypothesis is that obese women require less intrathecal hyperbaric bupivacaine than do normal weight women to achieve satisfactory surgical anesthesia for elective Cesarean section.Two groups of patients will be studied separately. Patients with BMI greater than or equal to 30 will be included in the obese group, also denominated study group. Patients with BMI less than 25 will be included in the normal weight group, also denominated control group. BMI will be calculated based on the patient's pre-pregnancy weight. For each group, the up-down sequential allocation method based on the Narayana rule will be used to find the minimum effective dose of intrathecal hyperbaric bupivacaine 0.75% associated with opioids necessary for satisfactory outcome in 95% of the pregnant women undergoing cesarean section, i.e. ED95.
There are two possible outcomes in our study: a satisfactory outcome is defined if the sensory block reaches at least at T6 and the patient does not complain of any pain or discomfort that requires intraoperative supplemental drugs; an unsatisfactory outcome is defined if the sensory block reaches a level lower than T6 or the patient complains of pain or discomfort that requires intraoperative supplemental drugs. The decision whether or not the supplementation is required will be made exclusively by the patient, and not by the physician in charge.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Obese group: All pregnant women at term (over 37 weeks) scheduled for elective Cesarean section, with pre-pregnancy BMI greater than 30
- Normal weight group: All pregnant women at term (over 37 weeks) scheduled for elective Cesarean section, with pre-pregnancy BMI less than 25.
Key exclusion criteria (5 listed)
- Patient's refusal.
- Patients with any absolute or relative contraindication for spinal/epidural anesthesia.
- Patients with BMI between 25 and 30.
- Patients with more than one fetus.
- Patients unable to communicate in English effectively.
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 0.75% with fentanyl and morphinethe following administered once, by spinal injection; 9-12 mg 0.75% hyperbaric bupivacaine 10 mcg fentanyl 100 mcg morphine | Drug | – |
Primary outcome
The primary outcome will be the success/failure of the block. Success meaning a sensory block level at least at T6 within 15 minutes after intrathecal injection and no requirement of any supplemental analgesic by the patient throughout the CS.
Time frame: 15 minutes
5 secondary outcomes
Upper level of sensory blockage determined by the pinprick at midaxillary line
Time frame: 60 minutes
VAPS during surgery
Time frame: 60 minutes
Dose of lidocaine 2% required as supplementation
Time frame: 60 minutes
Dose of IV fentanyl or ketamine required as supplementation
Time frame: 60 minutes
Conversion to general anesthesia
Time frame: 60 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 30 Jul 2009.
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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.
Jose CA Carvalho, MD PhD principal investigator
Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bupivacaine 0.75% with fentanyl and morphine in people with Pain and Obesity, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital 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 2 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 30 Jul 2009. 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?
The primary outcome will be the success/failure of the block. Success meaning a sensory block level at least at T6 within 15 minutes after intrathecal injection and no requirement of any supplemental analgesic by the patient throughout the CS. (time frame: 15 minutes). 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 30 Jul 2009.