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Completed

NCT Number: NCT03156322

Different Epidural Initiation Volumes

The aim of this study is to compare the effect of different epidural initiation volumes on postoperative pain scores, local anesthetic requirements, and motor block in patients who undergo patient controlled epidural analgesia for postoperative pain after cesarean section.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University Turgut Ozal Medical Center

Malatya, Turkey (Türkiye)

About this study

90 minutes after combined epidural spinal catheter insertion, three different volumes (5 mL, 10 mL, and 20 mL) are administered with a patient-controlled epidural analgesia (PCEA) device through the epidural catheter. For each group, 0.625% bupivacain + 2 μg/mL fentanyl, is administered.

The visual analog scale, first analgesic demand time, the number of PCEA requirement per hour, morphine requirement, nausea-vomiting, itching, motor block, hypotension, and total consumed analgesic, and ephedrine amounts of the patients are recorded in the recovery room and at postoperative 2, 4, 6, 12 hours.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiology risks classification II
  • Term pregnant

Exclusion criteria

  • Multiple pregnancy
  • Diabetes mellitus
  • Hypertension
  • Coagulopathy
  • Severe cardiac, neurological and pulmonary disease
  • Allergy to the study drugs
  • Difficulty in understanding the use of the patient controlled analgesia device

Treatment and study plan

5 mL epidural initiation volume (bupivacaine + fentanyl)

Drug

5 mL 0.625% bupivacaine + 2 μg/mL fentanyl solution is administered from epidural catheter

Other names: Bupivacaine(Marcaine 0.5%), Fentanyl(Talinat 0.5mg/10mL)

10 mL epidural initiation volume (bupivacaine + fentanyl)

Drug

10 mL 0.625% bupivacaine + 2 μg/mL fentanyl solution is administered from epidural catheter

Other names: Bupivacaine(Marcaine 0.5%), Fentanyl(Talinat 0.5mg/10mL)

20 mL epidural initiation volume (bupivacaine + fentanyl)

Drug

20 mL 0.625% bupivacaine + + 2 μg/mL fentanyl solution is administered from epidural catheter

Other names: Bupivacaine(Marcaine 0.5%), Fentanyl(Talinat 0.5mg/10mL)

Primary outcomes

  1. Change in postoperative pain scores

    Time frame: up to 12 hours after cesarean delivery

    Visual analog scale

Secondary outcomes

  1. First analgesic demand time

    Time frame: up to 12 hours after cesarean delivery

    Time to first analgesic requirement (first patient controlled epidural analgesic demand time)

  2. The number of analgesic requirement

    Time frame: up to 12 hours after cesarean delivery

    The number of patient controlled epidural analgesic requirement per hour

  3. Morphine requirement

    Time frame: up to 12 hours after cesarean delivery

    Intravenous morphine administration

Other outcomes

  1. Side effects associated with epidural analgesia

    Time frame: up to 12 hours after cesarean delivery

    Nausea-vomiting, itching, motor block, hypotension

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

Effects of Different Epidural Initiation Volumes on Postoperative Analgesia in Cesarean Delivery

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
May 17, 2017
Registry last updated
May 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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