Cesarean SectionNCT02577432
Two Syringe Spinal Anesthesia Technique for Cesarean Section: A Simple Way to Achieve More Satisfactory Block and Less Hypotension
A study testing fentanyl and Hyperbaric bupivacaine in people with Cesarean Section, run by Dr. Soliman Fakeeh Hospital.
Trial summary
Background: Poor spinal anaesthesia block is common and is difficult to manage; so a technique to minimize its incidence is advisable. Hypotension is the commonest problem with spinal anesthesia. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- fentanyl and Hyperbaric bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Oct 2014
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parturient at full term.
- Must be elective cesarean section.
- Must be uncomplicated pregnancy
Who cannot join
- Body weight <50 kg or >90 kg
- Height ˂150 cm or >170 cm.
- Pre-eclampsia.
- Any major systemic disease.
- Contraindication to regional anesthesia.
- Allergy to used medications.
About this study
Official title: Two Syringe Spinal Anesthesia Technique for Cesarean Section: A Controlled Randomized Study of a Simple Way to Achieve More Satisfactory Block and Less Hypotension
Background: Poor spinal anaesthesia block is common and is difficult to manage; so a technique to minimize its incidence is advisable. Hypotension is the commonest problem with spinal anesthesia. Multiple trials to prevent or combat hypotension using positional changes, fluid therapy and the use of vasopressors were tried. However, the drug choice and mode of administration as either bolus or infusion is still a matter of debate.
Objectives: To compare the outcome of spinal injection of hyperbaric bupivacaine and fentanyl separately to standard injection of mixed fentanyl with hyperbaric bupivacaine.
Read more
Design: A randomized, controlled clinical trial.
Setting: Single medical center from 5/2013 to 10/2014.
Patients \& Methods: 124 parturient scheduled for elective cesarean section (CS) were randomly allocated into two groups, each 62 parturient: Group M received spinal anesthesia using 10 mg bupivacaine 0.5% premixed with 25 µg fentanyl in the same syringe and Group S received 25 µg fentanyl in one syringe and 10 mg bupivacaine 0.5% without barbotage in a second syringe. Intravenous fluid co-load with 15 ml/kg warm lactated ringer solution was started as fast drip during, and continued after spinal anesthesia.
Patients were monitored for hemodynamic parameters, time of sensory onset and height of maximum sensory block, lower limb motor blockade was scored using modified Bromage scale and the frequency of side effects.
- Conditions
- Cesarean Section
- Being tested
- fentanyl, Hyperbaric bupivacaine
- Keywords
- spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanylDrug
Give 25 micro grams fentanyl intrathecal with one syringe. Then immediately give 10 mg hyperbaric bupivacaine intrathecally with an other syringe.
fentanylDrug
Mix 25 micro grams fentanyl with 10 mg hyperbaric bupivacaine in one syringe. Give them intrathecally.
Hyperbaric bupivacaineDrug
Give 25 micro grams fentanyl intrathecal with one syringe. Then immediately give 10 mg hyperbaric bupivacaine intrathecally with an other syringe.
hyperbaric bupivacaineDrug
Mix 25 micro grams fentanyl with 10 mg hyperbaric bupivacaine in one syringe. Give them intrathecally.
| Study group | Role | What they receive |
|---|---|---|
| (S) separate. | Active comparator | fentanyl and hyperbaric bupivacaine (sequentially) Receives: Drug: fentanyl; Drug: Hyperbaric bupivacaine |
| (M) mixed | Active comparator | fentanyl and hyperbaric bupivacaine.(mixed) Receives: Drug: fentanyl; Drug: hyperbaric bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of parturients needed more analgesics (unsatisfactory block) using Ochsner Health System.
Measured: intraoperative
incidence of hypotension
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startMay 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Soliman Fakeeh Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Amr Aly Ismail Keera, Dr. Soliman Fakeeh Hospital
- Investigators
- Amr A Keera, MD, Principal investigator, Dr. Benha Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577432
- Sponsor's protocol ID
- 01/REC/2013
- Status last verified
- Oct 2015
- First submitted
- 10 Oct 2015
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Syringe Spinal Anesthesia Technique for Cesarean Section: A Controlled Randomized Study of a Simple Way to Achieve More Satisfactory Block and Less Hypotension
- ClinicalTrials.gov ID
- NCT02577432
- Acronym / sponsor ID
- 01/REC/2013
- Conditions
- Cesarean Section
- Keywords
- spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Dr. Soliman Fakeeh HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 16 Oct 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.
Background: Poor spinal anaesthesia block is common and is difficult to manage; so a technique to minimize its incidence is advisable. Hypotension is the commonest problem with spinal anesthesia. Multiple trials to prevent or combat hypotension using positional changes, fluid therapy and the use of vasopressors were tried. However, the drug choice and mode of administration as either bolus or infusion is still a matter of debate.
Objectives: To compare the outcome of spinal injection of hyperbaric bupivacaine and fentanyl separately to standard injection of mixed fentanyl with hyperbaric bupivacaine.
Design: A randomized, controlled clinical trial.
Setting: Single medical center from 5/2013 to 10/2014.
Patients \& Methods: 124 parturient scheduled for elective cesarean section (CS) were randomly allocated into two groups, each 62 parturient: Group M received spinal anesthesia using 10 mg bupivacaine 0.5% premixed with 25 µg fentanyl in the same syringe and Group S received 25 µg fentanyl in one syringe and 10 mg bupivacaine 0.5% without barbotage in a second syringe. Intravenous fluid co-load with 15 ml/kg warm lactated ringer solution was started as fast drip during, and continued after spinal anesthesia.
Patients were monitored for hemodynamic parameters, time of sensory onset and height of maximum sensory block, lower limb motor blockade was scored using modified Bromage scale and the frequency of side effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (S) separate. | Active comparator | Drug: fentanyl, Drug: Hyperbaric bupivacainefentanyl and hyperbaric bupivacaine (sequentially) |
| (M) mixed | Active comparator | Drug: fentanyl, Drug: hyperbaric bupivacainefentanyl and hyperbaric bupivacaine.(mixed) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Parturient at full term.
- Must be elective cesarean section.
- Must be uncomplicated pregnancy
Key exclusion criteria (6 listed)
- Body weight <50 kg or >90 kg
- Height ˂150 cm or >170 cm.
- Pre-eclampsia.
- Any major systemic disease.
- Contraindication to regional anesthesia.
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 |
|---|---|---|
| fentanylGive 25 micro grams fentanyl intrathecal with one syringe. Then immediately give 10 mg hyperbaric bupivacaine intrathecally with an other syringe. | Drug | (S) separate. |
| fentanylMix 25 micro grams fentanyl with 10 mg hyperbaric bupivacaine in one syringe. Give them intrathecally. | Drug | (M) mixed |
| Hyperbaric bupivacaineGive 25 micro grams fentanyl intrathecal with one syringe. Then immediately give 10 mg hyperbaric bupivacaine intrathecally with an other syringe. | Drug | (S) separate. |
| hyperbaric bupivacaineMix 25 micro grams fentanyl with 10 mg hyperbaric bupivacaine in one syringe. Give them intrathecally. | Drug | (M) mixed |
Primary outcome
Number of parturients needed more analgesics (unsatisfactory block) using Ochsner Health System.
Time frame: intraoperative
incidence of hypotension
Time frame: intraoperative
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 20 Oct 2015.
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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.
Amr A Keera, MD principal investigator
Dr. Benha Faculty of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing fentanyl and Hyperbaric bupivacaine in people with Cesarean Section, run by Dr. Soliman Fakeeh Hospital.
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 3 inclusion and 6 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 20 Oct 2015. 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?
Number of parturients needed more analgesics (unsatisfactory block) using Ochsner Health System. (time frame: intraoperative). The study lists 2 primary outcomes in all. 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 20 Oct 2015.