Combined Spinal Epidural AnesthesiaNCT03219086
Spinal Prilocaine for Caesarian Sections
A study testing combined spinal epidural anaesthesia, Prilocaine and Bupivacaine in people with Combined Spinal Epidural Anesthesia and Prilocaine, run by University Hospital, Antwerp at 3 sites in Belgium.
Trial summary
Prilocaine theoretically could provide faster onset because of its lower pKa (7,7) compared to bupivacaine (8,1). The primary objective of this prospective double blind randomized trial is to determine block onset of spinal hyperbaric prilocaine compared to bupivacaine, both with a small dose of sufentanyl as an… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Combined Spinal Epidural Anesthesia, Prilocaine, Bupivacaine
- What is being tested?
- combined spinal epidural anaesthesia, Prilocaine and Bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 3 sitesBelgium
- Study dates
- 1 Aug 2017to 1 May 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A term Pregnant women (37-42 weeks)scheduled for caesarian section
Who cannot join
- Patient refusal
- Twin or multiple pregnancy
- Preeclampsia
- Contraindication neuraxial technique
- Indication general anaesthesia
- BMI before pregnancy >35
- Maternal height <155 cm
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
University Hospital Antwerp
Antwerp, 2650
AZ Middelheim
Berchem, Antwerpen, 2020
AZ KLina
Brasschaat, Antwerp
About this study
Official title: A Prospective Randomized Double Blind Comparison of 7,5 mg Hyperbaric Bupivacaine With 2,5mcg Sufentanyl or 50 mg Hyperbaric Prilocaine With 2,5 mcg Sufentanyl for Caesarean Sections
Prilocaine theoretically could provide faster onset because of its lower pKa (7,7) compared to bupivacaine (8,1). The primary objective of this prospective double blind randomized trial is to determine block onset of spinal hyperbaric prilocaine compared to bupivacaine, both with a small dose of sufentanyl as an additive.The primary hypothesis is that a significant larger amount of patients will gain surgical readiness within 8 minutes after spinal injection of prilocaine with sufentanyl compared to bupivacaine with sufentanyl. Surgical readiness is defined as a sensory block level of T5 tested by loss of cold sensation.
Read the detailed description
This study is designed as a randomised prospective double blind multi centre study.
Following approval by the Hospital Ethics committee of the University Hospital Antwerp and all participating hospitals, all-in term (37-42 weeks of gestation) pregnant women planned for a caesarean section will be asked to participate in this trial.
Patients will be randomised to receive either spinal prilocaine with sufentanyl or spinal bupivacaine with sufentanyl.The patient, the anaesthetist performing the CSE and the observer are not aware of the local anaesthetic solution administered.
Preoperative a combined spinal epidural puncture will be performed in the sitting position at the level of L2-L3 or L3-L4 . Vital parameters will be registered at regular intervals. Block characteristics ( onset, duration and intensity of the sensory block and motor block) will be measured at regular intervals.
Patients with insufficient analgesia will receive a top up dose of 5 ml lidocaine 2 % via the epidural catheter.
Time of birth, neonatal outcome (Apgar score 1 min, 5 min and 10 minutes after birth) and admission to the nicu as well as umbilicus venous and arterial blood gasses are recorded.
Patients will be discharged from the PACU when motor block reached a Bromage score 1 Time intervals of discharge to the ward will be registered.At the maternity ward the time of first contact of the baby and the mother and first breast feed (if applicable) will be registered.
One week postoperative patients will be called and asked if they experienced any postoperative symptoms like headache, micturition problems or symptoms resembling Transient Neurological Symptoms
- Conditions
- Combined Spinal Epidural Anesthesia, Prilocaine, Bupivacaine, Pain
- Being tested
- combined spinal epidural anaesthesia, Prilocaine, Bupivacaine
- Keywords
- combined spinal epidural anesthesia, caesarian section, prilocaine, bupivacaine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined spinal epidural anaesthesiaProcedure or surgery
Also called CSE, Spinal anesthesia, prilocaine
To give surgical anesthesia for performance of the caesarian section a combined spinal epidural anesthesia will be performed with different spinal solutions according to the appointed study group
PrilocaineDrug
Also called Tachipri
A combined spinal epidural anesthesia with spinal administration of 50 mg hyperbaric prilocaine 2% (Tachipri, Nordic Pharma) + 2,5mcg sufentanyl (5 mcg/ml) (Janssens-cilag)
BupivacaineDrug
Also called Marcaine
combined spinal epidural anesthesia with spinal administration of 7,5 mg hyperbaric bupivacaine 0,5% (Marcaine H) + 2,5mcg sufentanyl ( 5 mcg/ml)( Janssens -cilag) +1 ml nacl0,9%
| Study group | Role | What they receive |
|---|---|---|
| Group M | Active comparator | combined spinal epidural anesthesia with spinal administration of 7,5 mg hyperbaric bupivacaine 0,5% (Marcaine H) + 2,5mcg sufentanyl ( 5 mcg/ml)( Janssens -cilag) +1 ml nacl0,9% Receives: Procedure: combined spinal epidural anaesthesia; Drug: Bupivacaine |
| Group P | Active comparator | A combined spinal epidural anesthesia with spinal administration of 50 mg hyperbaric prilocaine 2% (Tachipri, Nordic Pharma) + 2,5mcg sufentanyl (5 mcg/ml) (Janssens-cilag) Receives: Procedure: combined spinal epidural anaesthesia; Drug: Prilocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
onset time surgical readiness
amount of minutes from spinal injection (T0) to loss of cold sensation on the fifth thoracic dermatome
Measured: from start spinal anaesthesia to start of surgery (up to 30 minutes)
Secondary outcomes (5)
regression interval of the motor block
Time from spinal injection to a Bromage score of 1 (knee flexion possible)
Measured: up to 3 hours
occurrence of hypotension
percentage of study group with hypotension defined as a systolic BP of less than 100 mm Hg or a 20% drop from the baseline level
Measured: from spinal injection(T0) to motor block regression ( up to 3 hours)
sensory block level
highest dermatome measured during the study
Measured: Up to 3 hours
discharge time maternity ward
the time interval from spinal injection (T0) to discharge to the maternity ward
Measured: Up to 3 hours
First Breast feed
the time interval from injection (T0) to first breast feeding
Measured: up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start1 Aug 2017
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Combined Spinal Epidural AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective double blind randomised
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- AZ Klina, AZ Middelheim
- Responsible party
- Principal investigator, Dr M. B. Breebaart, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219086
- Sponsor's protocol ID
- ec nr 17/07/77
- Status last verified
- Aug 2022
- First submitted
- 13 Jul 2017
- Last updated
- 5 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Double Blind Comparison of 7,5 mg Hyperbaric Bupivacaine With 2,5mcg Sufentanyl or 50 mg Hyperbaric Prilocaine With 2,5 mcg Sufentanyl for Caesarean Sections
- ClinicalTrials.gov ID
- NCT03219086
- Acronym / sponsor ID
- ec nr 17/07/77
- Conditions
- Combined Spinal Epidural Anesthesia, Prilocaine, Bupivacaine, Pain
- Keywords
- combined spinal epidural anesthesia, caesarian section, prilocaine, bupivacaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- AZ Klina, AZ Middelheim
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 17 Jul 2017 (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.
Prilocaine theoretically could provide faster onset because of its lower pKa (7,7) compared to bupivacaine (8,1). The primary objective of this prospective double blind randomized trial is to determine block onset of spinal hyperbaric prilocaine compared to bupivacaine, both with a small dose of sufentanyl as an additive.The primary hypothesis is that a significant larger amount of patients will gain surgical readiness within 8 minutes after spinal injection of prilocaine with sufentanyl compared to bupivacaine with sufentanyl. Surgical readiness is defined as a sensory block level of T5 tested by loss of cold sensation.
Detailed description
This study is designed as a randomised prospective double blind multi centre study.
Following approval by the Hospital Ethics committee of the University Hospital Antwerp and all participating hospitals, all-in term (37-42 weeks of gestation) pregnant women planned for a caesarean section will be asked to participate in this trial.
Patients will be randomised to receive either spinal prilocaine with sufentanyl or spinal bupivacaine with sufentanyl.The patient, the anaesthetist performing the CSE and the observer are not aware of the local anaesthetic solution administered.
Preoperative a combined spinal epidural puncture will be performed in the sitting position at the level of L2-L3 or L3-L4 . Vital parameters will be registered at regular intervals. Block characteristics ( onset, duration and intensity of the sensory block and motor block) will be measured at regular intervals.
Patients with insufficient analgesia will receive a top up dose of 5 ml lidocaine 2 % via the epidural catheter.
Time of birth, neonatal outcome (Apgar score 1 min, 5 min and 10 minutes after birth) and admission to the nicu as well as umbilicus venous and arterial blood gasses are recorded.
Patients will be discharged from the PACU when motor block reached a Bromage score 1 Time intervals of discharge to the ward will be registered.At the maternity ward the time of first contact of the baby and the mother and first breast feed (if applicable) will be registered.
One week postoperative patients will be called and asked if they experienced any postoperative symptoms like headache, micturition problems or symptoms resembling Transient Neurological Symptoms
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective double blind randomised
| Arm | Type | Receives |
|---|---|---|
| Group M | Active comparator | Procedure: combined spinal epidural anaesthesia, Drug: Bupivacainecombined spinal epidural anesthesia with spinal administration of 7,5 mg hyperbaric bupivacaine 0,5% (Marcaine H) + 2,5mcg sufentanyl ( 5 mcg/ml)( Janssens -cilag) +1 ml nacl0,9% |
| Group P | Active comparator | Procedure: combined spinal epidural anaesthesia, Drug: PrilocaineA combined spinal epidural anesthesia with spinal administration of 50 mg hyperbaric prilocaine 2% (Tachipri, Nordic Pharma) + 2,5mcg sufentanyl (5 mcg/ml) (Janssens-cilag) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A term Pregnant women (37-42 weeks)scheduled for caesarian section
Key exclusion criteria (7 listed)
- Patient refusal
- Twin or multiple pregnancy
- Preeclampsia
- Contraindication neuraxial technique
- Indication general anaesthesia
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 |
|---|---|---|
| combined spinal epidural anaesthesiaAlso: CSE, Spinal anesthesia, prilocaineTo give surgical anesthesia for performance of the caesarian section a combined spinal epidural anesthesia will be performed with different spinal solutions according to the appointed study group | Procedure or surgery | Group M, Group P |
| PrilocaineAlso: TachipriA combined spinal epidural anesthesia with spinal administration of 50 mg hyperbaric prilocaine 2% (Tachipri, Nordic Pharma) + 2,5mcg sufentanyl (5 mcg/ml) (Janssens-cilag) | Drug | Group P |
| BupivacaineAlso: Marcainecombined spinal epidural anesthesia with spinal administration of 7,5 mg hyperbaric bupivacaine 0,5% (Marcaine H) + 2,5mcg sufentanyl ( 5 mcg/ml)( Janssens -cilag) +1 ml nacl0,9% | Drug | Group M |
Primary outcome
onset time surgical readiness
Time frame: from start spinal anaesthesia to start of surgery (up to 30 minutes)
amount of minutes from spinal injection (T0) to loss of cold sensation on the fifth thoracic dermatome
5 secondary outcomes
regression interval of the motor block
Time frame: up to 3 hours
occurrence of hypotension
Time frame: from spinal injection(T0) to motor block regression ( up to 3 hours)
sensory block level
Time frame: Up to 3 hours
discharge time maternity ward
Time frame: Up to 3 hours
First Breast feed
Time frame: up to 6 hours
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 5 Aug 2022.
Related trials for Combined Spinal Epidural Anesthesia
RecruitingObservational study
Anesthetic Technique and Quality of Recovery After Cesarean Delivery
Ceserean Section, Obstetric Quality of Recovery
Recruiting
Comparison of Different Anesthetic Techniques on Hearing Outcomes in Neonates After Cesarean Delivery
Pregnancy, Neonatal Hearing Function
Not yet recruitingObservational study
Perfusion Index Variability During Epidural Labor Analgesia
Labor Epidural Analgesia, Perfusion Index
Enrolling by invitationObservational study
Conversion of Labor Analgesia for Intrapartum Cesarean Delivery: DPE v CSE v Epidural
Anesthesia, Analgesia
Recruiting
Comparison of the Effects of General Anesthesia and Combined Spinal-Epidural Anesthesia on Ferroptosis, Humanin and MOTS-c Levels in Renal Transplantation
Kidney Disease, End-Stage, Kidney Transplant
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined spinal epidural anaesthesia, Prilocaine and Bupivacaine in people with Combined Spinal Epidural Anesthesia and Prilocaine, run by University Hospital, Antwerp at 3 sites in Belgium.
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 7 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 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. 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?
onset time surgical readiness (time frame: from start spinal anaesthesia to start of surgery (up to 30 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 5 Aug 2022.