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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Indonesia

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.

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 groups in NCT03834454
Study groupRoleWhat they receive
Bupivacaine 5 mgActive comparator5 mg hyperbaric bupivacaine 0.5% and 25 mcg fentanyl for spinal anesthesia
Receives: Drug: Bupivacaine
Bupivacaine 7.5 mgActive comparator7.5 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.

  1. 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)

  1. Adequacy of Anesthesia

    Requirement of additional local anesthetics

    Measured: 120 minutes

  2. Quality of anesthesia: as reported by patients and surgeons

    Quality of anesthesia as reported by patients and surgeons

    Measured: 120 minutes

  3. 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.

  1. First posted8 Feb 2019
  2. Study start1 Oct 2013
  3. Primary completion31 Dec 2013
  4. Study completion31 Dec 2013

Resources

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)
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 21764820

  • Rollins 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 22219238

  • Lee 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 12067872

  • Banerjee 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 19859776

  • Practice 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 26580836

  • Qiu 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 22533726

  • Ituk 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 29770203

  • Corso 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 28320342

  • Leo 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 19843797

  • Ben-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 10834776

  • Ota 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

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.

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