AnesthesiaNCT03006042
Pharmacokinetics of BPV Following Bilateral US-guided TAP Block for C-section
An observational study of Anesthesia and Adverse Effect, run by University Tunis El Manar.
Trial summary
The transversus abdominis plane block (TAP block) is an effective method of postoperative pain management after cesarean section (C-section). Up to now, there are no data available about bupivacaine (BPV) plasma levels after TAP block in adults. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Anesthesia, Adverse Effect, Cesarean Section
- What is being tested?
- Bupivacaine
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to May 2015
- Phase
- Observational
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: After obtaining approval by the institute ethics committee and having written informed consent signed on the day of surgery, 17 American Society of Anesthesiologists (ASA) physical status I-II pregnant women aged between 20 and 40 years scheduled for elective C-section with Pfannenstiel incision, under SA, were enrolled in this study.
Who may be able to join
- ASA physical status I-II pregnant women scheduled for elective C-section with Pfannenstiel incision under Spinal anesthesia
Who cannot join
- ASA physical status > II,
- known allergy to local anesthetics,
- body mass index (BMI) more than 40 kg/m²,
- coagulation disorders,
- neurologic or neuromuscular disease,
- significant liver or renal dysfunction,
Show all 10Show fewer
- electrolyte disturbances,
- heart arrhythmias,
- corrected QT (QTc) interval> 0.47s
- patients taking drugs that may prolong QT interval.
About this study
Official title: Pharmacokinetics of Bupivacaine Following Bilateral Ultrasound-guided Transversus Abdominis Plane Block for Cesarean Section
The transversus abdominis plane block (TAP block) is an effective method of postoperative pain management after cesarean section (C-section). Up to now, there are no data available about bupivacaine (BPV) plasma levels after TAP block in adults. In the current study, the investigators aimed to assess BPV pharmacokinetic parameters after ultrasound-guided TAP block using BPV in parturients undergoing C-section and to report its effects on corrected QT interval.
Read the detailed description
The investigators led a prospective observational study in pregnant women undergoing elective C-section under spinal anesthesia (SA) using 10 mg of hyperbaric BPV. After surgery, they received bilateral ultrasound-guided TAP block with 50 mg of BPV in each side. Venous blood samples were collected immediately before and at 10, 30, 45, 60, 90, 120, 180, 240, 720 and 1440 minutes after both TAP blocks. The investigators used high performance liquid chromatography (HPLC) to measure BPV total plasma concentrations. Mean BPV area under the curve (AUC) was calculated from 0 to 24 hours according to the linear trapezoidal rule. Mean peak of total BPV plasma concentration (Cmax) and time to reach the peak (Tmax) were recorded. Electrocardiographic (ECG) recordings were also repeated at 1, 2, 3 and 4 hours to investigate the effect of BPV on corrected QT (QTc) intervals. Data were computed using SPSS 20®. Quantitative data were expressed as means ± SD. Qualitative data were expressed as percentages.
- Being tested
- Bupivacaine
- Keywords
- bupivacaine, local anaesthetics, cesarean section, transversus abdominis plane block, toxicity, ultrasound guidance, QTc interval
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Total venous plasma concentration of BPV
Measured: Immediately before and at 10, 30, 45, 60, 90, 120, 180, 240, 720 and 1440 minutes after both TAP blocks.
Secondary outcomes (1)
corrected QT interval
Measured: at 1, 2, 3 and 4 hours after TAP blocks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startNov 2014
- Primary completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben marzouk Sofiene, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006042
- Sponsor's protocol ID
- UTEM BPV
- Status last verified
- Dec 2016
- First submitted
- 20 Dec 2016
- Last updated
- 30 Dec 2016
- 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 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Bupivacaine Following Bilateral Ultrasound-guided Transversus Abdominis Plane Block for Cesarean Section
- ClinicalTrials.gov ID
- NCT03006042
- Acronym / sponsor ID
- UTEM BPV
- Keywords
- bupivacaine, local anaesthetics, cesarean section, transversus abdominis plane block, toxicity, ultrasound guidance, QTc interval
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- May 2015 (actual)
- First posted
- 30 Dec 2016 (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.
The transversus abdominis plane block (TAP block) is an effective method of postoperative pain management after cesarean section (C-section). Up to now, there are no data available about bupivacaine (BPV) plasma levels after TAP block in adults. In the current study, the investigators aimed to assess BPV pharmacokinetic parameters after ultrasound-guided TAP block using BPV in parturients undergoing C-section and to report its effects on corrected QT interval.
Detailed description
The investigators led a prospective observational study in pregnant women undergoing elective C-section under spinal anesthesia (SA) using 10 mg of hyperbaric BPV. After surgery, they received bilateral ultrasound-guided TAP block with 50 mg of BPV in each side. Venous blood samples were collected immediately before and at 10, 30, 45, 60, 90, 120, 180, 240, 720 and 1440 minutes after both TAP blocks. The investigators used high performance liquid chromatography (HPLC) to measure BPV total plasma concentrations. Mean BPV area under the curve (AUC) was calculated from 0 to 24 hours according to the linear trapezoidal rule. Mean peak of total BPV plasma concentration (Cmax) and time to reach the peak (Tmax) were recorded. Electrocardiographic (ECG) recordings were also repeated at 1, 2, 3 and 4 hours to investigate the effect of BPV on corrected QT (QTc) intervals. Data were computed using SPSS 20®. Quantitative data were expressed as means ± SD. Qualitative data were expressed as percentages.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- After obtaining approval by the institute ethics committee and having written informed consent signed on the day of surgery, 17 American Society of Anesthesiologists (ASA) physical status I-II pregnant women aged between 20 and 40 years scheduled for elective C-section with Pfannenstiel incision, under SA, were enrolled in this study.
Key inclusion criteria (1 listed)
- ASA physical status I-II pregnant women scheduled for elective C-section with Pfannenstiel incision under Spinal anesthesia
Key exclusion criteria (10 listed)
- ASA physical status > II,
- known allergy to local anesthetics,
- body mass index (BMI) more than 40 kg/m²,
- coagulation disorders,
- neurologic or neuromuscular disease,
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 | Drug | – |
Primary outcome
Total venous plasma concentration of BPV
Time frame: Immediately before and at 10, 30, 45, 60, 90, 120, 180, 240, 720 and 1440 minutes after both TAP blocks.
1 secondary outcome
corrected QT interval
Time frame: at 1, 2, 3 and 4 hours after TAP blocks
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 Dec 2016.
- Individual participant dataSharing planned: No
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Adverse Effect, run by University Tunis El Manar.
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 1 inclusion and 10 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 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Total venous plasma concentration of BPV (time frame: Immediately before and at 10, 30, 45, 60, 90, 120, 180, 240, 720 and 1440 minutes after both TAP blocks.). 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 Dec 2016.