Bupivacaine 5 mg vs 7.5 mg for Spinal Anesthesia in Cesarean Delivery in Indonesian Population
Condition: Cesarean Section; Hypotension Drug-Induced; Spinal Anesthesia; Postoperative Complications
MeSH terms: Hypotension; Postoperative Complications
Study type: Interventional

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
    

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.
    

Intervention name(s): Bupivacaine; Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg hyperbaric bupivacaine 0.5% and 25 mcg fentanyl for spinal anesthesia; 7.5 mg hyperbaric bupivacaine 0.5% and 25 mcg fentanyl for spinal anesthesia
Other intervention name(s): 5 mg hyperbaric bupivacaine 0.5%; 7.5 mg hyperbaric bupivacaine 0.5%
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: pregnancy; caesarean section; spinal anesthesia; bupivacaine; opioid; hypotension; intraoperative; postoperative