Cesarean SectionNCT03834454
Bupivacaine 5 mg vs 7.5 mg for Spinal Anesthesia in Cesarean Delivery in Indonesian Population
A study testing Bupivacaine in people with Cesarean Section and Hypotension Drug-Induced, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study aims to evaluate the efficacy of hyperbaric 5 mg bupivacaine + fentanyl 25 mcg versus hyperbaric 7.5 mg bupivacaine + fentanyl 25 mcg to lower incidence of hypotension 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
- Cesarean Section, Hypotension Drug-Induced, Spinal Anesthesia
- What is being tested?
- Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2013to 31 Dec 2013
- 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
- pregnant women with ASA PS 1-3
- age 18-40 years old
- in an elective or emergency cesarean delivery using spinal anesthesia
Who cannot join
- patients with contraindication of spinal anesthesia
- have history of allergy to bupivacaine or fentanyl
- with eclampsia
- valvular heart disease
- congenital heart disease
- coronary heart disease
Show all 9Show fewer
- twin pregnancy
- morbid obesity (BMI >=40)
- pre-partum hemorrhage with hemodynamic instability
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: How Low Can we go: A Double-blinded Randomized Controlled Trial to Compare Bupivacaine 5 mg and Bupivacaine 7.5 mg for Spinal Anesthesia in Cesarian Delivery in Indonesian Population
This study aims to evaluate the efficacy of hyperbaric 5 mg bupivacaine + fentanyl 25 mcg versus hyperbaric 7.5 mg bupivacaine + fentanyl 25 mcg to lower incidence of hypotension
Read the detailed description
Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects will be recruited using consecutive sampling method. Sample size was determined using alpha 5%, power 80%, and the difference of the incidence of hypotension 20%. The sample of each group is 56 patients. The investigators will use ECG, blood pressure monitoring, and pulse oxymetry for the standard monitoring. Patients will be given oxygen 3 L/minute via nasal cannula. Before the spinal anesthesia, patients will be given co-loading 500 ml of Ringer Lactate. Patients will be in sitting position while the lumbal puncture is conducted using 27G Quincke in the level of L3-4 or L4-5 or Tuffier's line. After ensuring that the tip of the needle is in the subarachnoid space, the drug will be administered with the speed of 0.2 mL/s. All the procedure will be conducted in sterile condition. Patients will receive ketoprofen suppositoria as the postoperative analgesia and can be discharged to the ward when the Aldrete's score is more than 8.
The onset of sensoric blockade is assessed using pinprick test until the level of T6 or maximum until 20 minute. The peak value will be recorded. The motor blockade will be assessed using the Bromage scale. Incision will be done when the level of sensory block reached T6. If patients report pain after delivery of the baby, intravenous fentanyl 0,67-1 mcg/kg will be given twice with the interval of 10 minutes. If pain persists, conversion to general anesthesia will be conducted.
The measurement of blood pressure, heart rate, respiratory rate, temperature, and O2 saturation will be recorded during the minute of 3, 6, 9, 12, 15, 20, 30, 40, 50, and 60 after the spinal anesthesia is administered or until the baby is delivered. Patients will be recorded as hypotensive when she experienced reduction of blood pressure more than 30% from baseline or systolic pressure less than 100 mmHg from the moment the spinal anesthesia is administered until the baby is delivered. If the systolic pressure is less than 90 mmHg, patient will be given ephedrine 5 mg iv that is repeated every minute until the systolic pressure is over 90 mmHg.
The duration of the surgery is also recorded. Nausea, vomiting, syncope, dizziness, chest discomfort, and other intraoperative complaint will be recorded. Postoperative nausea and vomiting, itching, shivering, back pain, Post Dural Puncture Headache (PDPH), and Transient Neurologic Symptoms (TNS) will also be recorded.
- Conditions
- Cesarean Section, Hypotension Drug-Induced, Spinal Anesthesia, Postoperative Complications
- Being tested
- Bupivacaine
- Keywords
- pregnancy, caesarean section, spinal anesthesia, bupivacaine, opioid, hypotension, intraoperative, postoperative
- Medical subject headings
- Hypotension, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called 5 mg hyperbaric bupivacaine 0.5%
5 mg hyperbaric bupivacaine 0.5% and 25 mcg fentanyl for spinal anesthesia
BupivacaineDrug
Also called 7.5 mg hyperbaric bupivacaine 0.5%
7.5 mg hyperbaric bupivacaine 0.5% and 25 mcg fentanyl for spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine 5 mg | Active comparator | 5 mg hyperbaric bupivacaine 0.5% and 25 mcg fentanyl for spinal anesthesia Receives: Drug: Bupivacaine |
| Bupivacaine 7.5 mg | Active comparator | 7.5 mg hyperbaric bupivacaine 0.5% and 25 mcg fentanyl for spinal anesthesia Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypotension
recorded during the minute of 3, 6, 9, 12, 15, 20, 30, 40, 50, and 60 after the spinal anesthesia will be administered or until the baby is delivered
Measured: 60 minutes
Secondary outcomes (3)
Adequacy of Anesthesia
Requirement of additional local anesthetics
Measured: 120 minutes
Quality of anesthesia: as reported by patients and surgeons
Quality of anesthesia as reported by patients and surgeons
Measured: 120 minutes
Motor recovery
Duration of motor recovery after surgery
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start1 Oct 2013
- Primary completion31 Dec 2013
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susilo Chandra, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834454
- Sponsor's protocol ID
- IndonesiaUAnes027
- Status last verified
- Feb 2019
- First submitted
- 1 Feb 2019
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Arzola C, Wieczorek PM. Efficacy of low-dose bupivacaine in spinal anaesthesia for Caesarean delivery: systematic review and meta-analysis. Br J Anaesth. 2011 Sep;107(3):308-18. doi: 10.1093/bja/aer200. Epub 2011 Jul 14.
PubMed 21764820Rollins M, Lucero J. Overview of anesthetic considerations for Cesarean delivery. Br Med Bull. 2012;101:105-25. doi: 10.1093/bmb/ldr050. Epub 2012 Jan 4.
PubMed 22219238Lee A, Ngan Kee WD, Gin T. Prophylactic ephedrine prevents hypotension during spinal anesthesia for Cesarean delivery but does not improve neonatal outcome: a quantitative systematic review. Can J Anaesth. 2002 Jun-Jul;49(6):588-99. doi: 10.1007/BF03017387.
PubMed 12067872Banerjee A, Stocche RM, Angle P, Halpern SH. Preload or coload for spinal anesthesia for elective Cesarean delivery: a meta-analysis. Can J Anaesth. 2010 Jan;57(1):24-31. doi: 10.1007/s12630-009-9206-7. Epub 2009 Oct 27.
PubMed 19859776Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.
PubMed 26580836Qiu MT, Lin FQ, Fu SK, Zhang HB, Li HH, Zhang LM, Li Q. Combination of low-dose bupivacaine and opioids provides satisfactory analgesia with less intraoperative hypotension for spinal anesthesia in cesarean section. CNS Neurosci Ther. 2012 May;18(5):426-32. doi: 10.1111/j.1755-5949.2012.00306.x.
PubMed 22533726Ituk U, Habib AS. Enhanced recovery after cesarean delivery. F1000Res. 2018 Apr 27;7:F1000 Faculty Rev-513. doi: 10.12688/f1000research.13895.1. eCollection 2018.
PubMed 29770203Corso E, Hind D, Beever D, Fuller G, Wilson MJ, Wrench IJ, Chambers D. Enhanced recovery after elective caesarean: a rapid review of clinical protocols, and an umbrella review of systematic reviews. BMC Pregnancy Childbirth. 2017 Mar 20;17(1):91. doi: 10.1186/s12884-017-1265-0.
PubMed 28320342Leo S, Sng BL, Lim Y, Sia AT. A randomized comparison of low doses of hyperbaric bupivacaine in combined spinal-epidural anesthesia for cesarean delivery. Anesth Analg. 2009 Nov;109(5):1600-5. doi: 10.1213/ANE.0b013e3181b72d35.
PubMed 19843797Ben-David B, Miller G, Gavriel R, Gurevitch A. Low-dose bupivacaine-fentanyl spinal anesthesia for cesarean delivery. Reg Anesth Pain Med. 2000 May-Jun;25(3):235-9.
PubMed 10834776Ota E, Haruna M, Suzuki M, Anh DD, Tho le H, Tam NT, Thiem VD, Anh NT, Isozaki M, Shibuya K, Ariyoshi K, Murashima S, Moriuchi H, Yanai H. Maternal body mass index and gestational weight gain and their association with perinatal outcomes in Viet Nam. Bull World Health Organ. 2011 Feb 1;89(2):127-36. doi: 10.2471/BLT.10.077982. Epub 2010 Nov 10.
PubMed 21346924
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Low Can we go: A Double-blinded Randomized Controlled Trial to Compare Bupivacaine 5 mg and Bupivacaine 7.5 mg for Spinal Anesthesia in Cesarian Delivery in Indonesian Population
- ClinicalTrials.gov ID
- NCT03834454
- Acronym / sponsor ID
- IndonesiaUAnes027
- Conditions
- Cesarean Section, Hypotension Drug-Induced, Spinal Anesthesia, Postoperative Complications
- Keywords
- pregnancy, caesarean section, spinal anesthesia, bupivacaine, opioid, hypotension, intraoperative, postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 8 Feb 2019 (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.
This study aims to evaluate the efficacy of hyperbaric 5 mg bupivacaine + fentanyl 25 mcg versus hyperbaric 7.5 mg bupivacaine + fentanyl 25 mcg to lower incidence of hypotension
Detailed description
Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects will be recruited using consecutive sampling method. Sample size was determined using alpha 5%, power 80%, and the difference of the incidence of hypotension 20%. The sample of each group is 56 patients. The investigators will use ECG, blood pressure monitoring, and pulse oxymetry for the standard monitoring. Patients will be given oxygen 3 L/minute via nasal cannula. Before the spinal anesthesia, patients will be given co-loading 500 ml of Ringer Lactate. Patients will be in sitting position while the lumbal puncture is conducted using 27G Quincke in the level of L3-4 or L4-5 or Tuffier's line. After ensuring that the tip of the needle is in the subarachnoid space, the drug will be administered with the speed of 0.2 mL/s. All the procedure will be conducted in sterile condition. Patients will receive ketoprofen suppositoria as the postoperative analgesia and can be discharged to the ward when the Aldrete's score is more than 8.
The onset of sensoric blockade is assessed using pinprick test until the level of T6 or maximum until 20 minute. The peak value will be recorded. The motor blockade will be assessed using the Bromage scale. Incision will be done when the level of sensory block reached T6. If patients report pain after delivery of the baby, intravenous fentanyl 0,67-1 mcg/kg will be given twice with the interval of 10 minutes. If pain persists, conversion to general anesthesia will be conducted.
The measurement of blood pressure, heart rate, respiratory rate, temperature, and O2 saturation will be recorded during the minute of 3, 6, 9, 12, 15, 20, 30, 40, 50, and 60 after the spinal anesthesia is administered or until the baby is delivered. Patients will be recorded as hypotensive when she experienced reduction of blood pressure more than 30% from baseline or systolic pressure less than 100 mmHg from the moment the spinal anesthesia is administered until the baby is delivered. If the systolic pressure is less than 90 mmHg, patient will be given ephedrine 5 mg iv that is repeated every minute until the systolic pressure is over 90 mmHg.
The duration of the surgery is also recorded. Nausea, vomiting, syncope, dizziness, chest discomfort, and other intraoperative complaint will be recorded. Postoperative nausea and vomiting, itching, shivering, back pain, Post Dural Puncture Headache (PDPH), and Transient Neurologic Symptoms (TNS) will also be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine 5 mg | Active comparator | Drug: Bupivacaine5 mg hyperbaric bupivacaine 0.5% and 25 mcg fentanyl for spinal anesthesia |
| Bupivacaine 7.5 mg | Active comparator | Drug: Bupivacaine7.5 mg hyperbaric bupivacaine 0.5% and 25 mcg fentanyl for spinal anesthesia |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- pregnant women with ASA PS 1-3
- age 18-40 years old
- in an elective or emergency cesarean delivery using spinal anesthesia
Key exclusion criteria (9 listed)
- patients with contraindication of spinal anesthesia
- have history of allergy to bupivacaine or fentanyl
- with eclampsia
- valvular heart disease
- congenital heart 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 |
|---|---|---|
| BupivacaineAlso: 5 mg hyperbaric bupivacaine 0.5%5 mg hyperbaric bupivacaine 0.5% and 25 mcg fentanyl for spinal anesthesia | Drug | Bupivacaine 5 mg |
| BupivacaineAlso: 7.5 mg hyperbaric bupivacaine 0.5%7.5 mg hyperbaric bupivacaine 0.5% and 25 mcg fentanyl for spinal anesthesia | Drug | Bupivacaine 7.5 mg |
Primary outcome
Incidence of hypotension
Time frame: 60 minutes
recorded during the minute of 3, 6, 9, 12, 15, 20, 30, 40, 50, and 60 after the spinal anesthesia will be administered or until the baby is delivered
3 secondary outcomes
Adequacy of Anesthesia
Time frame: 120 minutes
Quality of anesthesia: as reported by patients and surgeons
Time frame: 120 minutes
Motor recovery
Time frame: 10 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 11 Feb 2019.
- Background: PubMed 21764820Arzola C, Wieczorek PM. Efficacy of low-dose bupivacaine in spinal anaesthesia for Caesarean delivery: systematic review and meta-analysis. Br J Anaesth. 2011 Sep;107(3):308-18. doi: 10.1093/bja/aer200. Epub 2011 Jul 14.
- Background: PubMed 22219238Rollins M, Lucero J. Overview of anesthetic considerations for Cesarean delivery. Br Med Bull. 2012;101:105-25. doi: 10.1093/bmb/ldr050. Epub 2012 Jan 4.
- Background: PubMed 12067872Lee A, Ngan Kee WD, Gin T. Prophylactic ephedrine prevents hypotension during spinal anesthesia for Cesarean delivery but does not improve neonatal outcome: a quantitative systematic review. Can J Anaesth. 2002 Jun-Jul;49(6):588-99. doi: 10.1007/BF03017387.
- Background: PubMed 19859776Banerjee A, Stocche RM, Angle P, Halpern SH. Preload or coload for spinal anesthesia for elective Cesarean delivery: a meta-analysis. Can J Anaesth. 2010 Jan;57(1):24-31. doi: 10.1007/s12630-009-9206-7. Epub 2009 Oct 27.
- Background: PubMed 26580836Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.
- Background: PubMed 22533726Qiu MT, Lin FQ, Fu SK, Zhang HB, Li HH, Zhang LM, Li Q. Combination of low-dose bupivacaine and opioids provides satisfactory analgesia with less intraoperative hypotension for spinal anesthesia in cesarean section. CNS Neurosci Ther. 2012 May;18(5):426-32. doi: 10.1111/j.1755-5949.2012.00306.x.
- Background: PubMed 29770203Ituk U, Habib AS. Enhanced recovery after cesarean delivery. F1000Res. 2018 Apr 27;7:F1000 Faculty Rev-513. doi: 10.12688/f1000research.13895.1. eCollection 2018.
- Background: PubMed 28320342Corso E, Hind D, Beever D, Fuller G, Wilson MJ, Wrench IJ, Chambers D. Enhanced recovery after elective caesarean: a rapid review of clinical protocols, and an umbrella review of systematic reviews. BMC Pregnancy Childbirth. 2017 Mar 20;17(1):91. doi: 10.1186/s12884-017-1265-0.
- Background: PubMed 19843797Leo S, Sng BL, Lim Y, Sia AT. A randomized comparison of low doses of hyperbaric bupivacaine in combined spinal-epidural anesthesia for cesarean delivery. Anesth Analg. 2009 Nov;109(5):1600-5. doi: 10.1213/ANE.0b013e3181b72d35.
- Background: PubMed 10834776Ben-David B, Miller G, Gavriel R, Gurevitch A. Low-dose bupivacaine-fentanyl spinal anesthesia for cesarean delivery. Reg Anesth Pain Med. 2000 May-Jun;25(3):235-9.
- Background: PubMed 21346924Ota E, Haruna M, Suzuki M, Anh DD, Tho le H, Tam NT, Thiem VD, Anh NT, Isozaki M, Shibuya K, Ariyoshi K, Murashima S, Moriuchi H, Yanai H. Maternal body mass index and gestational weight gain and their association with perinatal outcomes in Viet Nam. Bull World Health Organ. 2011 Feb 1;89(2):127-36. doi: 10.2471/BLT.10.077982. Epub 2010 Nov 10.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Cesarean Section and Hypotension Drug-Induced, run by Universitas Indonesia at 1 site in Indonesia.
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 9 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 11 Feb 2019. 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 Indonesia. 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?
Incidence of hypotension (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03834454, which also lists 11 linked publications.
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 11 Feb 2019; AzTrials last refreshed its copy on 7 Nov 2026.