Bupivacaine 5 mg vs 7.5 mg for Spinal Anesthesia in Cesarean Delivery in Indonesian Population

NCT03834454 | Completed DMC

• 1 other identifier: IndonesiaUAnes027
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cesarean Section; Hypotension Drug-Induced; Spinal Anesthesia; Postoperative Complications

Keywords

pregnancy; caesarean section; spinal anesthesia; bupivacaine; opioid; hypotension; intraoperative; postoperative

Outcome Measures

Primary Outcomes (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

  60 minutes

Secondary Outcomes (3)

• Adequacy of Anesthesia

  120 minutes

• Quality of anesthesia: as reported by patients and surgeons

  120 minutes

• Motor recovery

  10 hours

Study Arms (2)

Bupivacaine 5 mg

ACTIVE COMPARATOR

5 mg hyperbaric bupivacaine 0.5% and 25 mcg fentanyl for spinal anesthesia

Drug: Bupivacaine

Bupivacaine 7.5 mg

ACTIVE COMPARATOR

7.5 mg hyperbaric bupivacaine 0.5% and 25 mcg fentanyl for spinal anesthesia

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

5 mg hyperbaric bupivacaine 0.5% and 25 mcg fentanyl for spinal anesthesia

Also known as: 5 mg hyperbaric bupivacaine 0.5%

Bupivacaine 5 mg

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant women with ASA PS 1-3
• age 18-40 years old
• in an elective or emergency cesarean delivery using spinal anesthesia

You may not qualify if:

• 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
• twin pregnancy
• morbid obesity (BMI \>=40)
• pre-partum hemorrhage with hemodynamic instability

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (11)

• 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.

  PMID: 21764820 BACKGROUND

• 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.

  PMID: 22219238 BACKGROUND

• 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.

  PMID: 12067872 BACKGROUND

• 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.

  PMID: 19859776 BACKGROUND

• 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.

  PMID: 26580836 BACKGROUND

• 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.

  PMID: 22533726 BACKGROUND

• 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.

  PMID: 29770203 BACKGROUND

• 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.

  PMID: 28320342 BACKGROUND

• 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.

  PMID: 19843797 BACKGROUND

• 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.

  PMID: 10834776 BACKGROUND

• 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.

  PMID: 21346924 BACKGROUND

MeSH Terms

Conditions

Hypotension; Postoperative Complications

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Simple randomization will be conducted using a software by one of the researchers (HA) into two groups with equal size. To ensure the concealment, the randomization list will be kept in a sealed enveloped and opened by the physician who administered the spinal anesthesia just before the surgery. Data recording will be conducted by independent observers. This is a double-blinded study for the subjects and for the observers. The enrollment of the participants will be conducted by HA. Patients will not be notified about the dose scheme. Physician who performed the spinal anesthesia are different from the observers. Observers are junior residents trained to test the spinal adequacy and to perform monitoring in spinal anesthesia. It us not possible to blind the physicians who perform the spinal anesthesia because they will notice the volume difference.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 8, 2019
• Study Start: October 1, 2013
• Primary Completion: December 31, 2013
• Study Completion: December 31, 2013
• Last Updated: February 11, 2019

Record last verified: 2019-02

Locations

ID (1)