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OpenTrials
Completed

NCT Number: NCT03946982

Comparisons Between Low Thoracic and Lumbar Epidural Analgesia on Postoperative Pain Low Thoracic v.s. Lumbar Epidural for Post-cesarean Pain

Whether low thoracic epidural analgesia improves postoperative cesarean pain qualities than conventional lumbar epidural analgesia?

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Key information

Conditions

Post-cesarean Pain Control Quality

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

About this study

Postoperative pain remains the leading cause of concern in women faced with undergoing a cesarean delivery. Inadequate acute pain management is associated with numerous negative effects, including delayed postpartum recovery, interference with mother-child bonding because postoperative pain limits breastfeeding, and a high risk of postpartum depression and persistent pain.

Epidural analgesia (EA) is being increasingly preferred to systemic opioid because of better analgesic effect. Although EA is widely used for cesarean delivery, the effect of the site of epidural catheter insertion on the quality of postoperative pain management remains inadequately investigated. For example, placement of the epidural catheter in the low thoracic intervertebral spaces may be more suitable for catheter-incision-congruent analgesia during caesarean delivery than in the lumbar intervertebral space; however, epidural catheter insertion is conventionally recommended at the lumbar intervertebral space. Therefore, in this study, we aim to investigate the difference in post-cesarean pain control quality between low thoracic EA and lumbar EA.

Who can participate

Healthy volunteers accepted: No

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

Inclusion:

  • age between 20-yr and 50-yr parturients
  • elective cesarean delivery

Exclusion:

  • contraindicated to regional anesthesia, eg. coagulopathy (INR> 1.5; platelet< 80000...etc)
  • significant co-morbidities, eg. preeclamspia, heart failure with New York Heart Association (NYHA) Classification> class 2
  • allergy to opioids or local anesthetics

Treatment and study plan

low thoracic epidural

Procedure

obstetric epidural catheters inserted at low thoracic intervertebral spaces

lumbar epidural

Procedure

obstetric epidural catheters inserted at low thoracic intervertebral spaces (conventional)

Primary outcomes

  1. Proportion of women with a visual analogue scale> 33 mm

    Time frame: postoperative two days

  2. Pain intensity

    Time frame: postoperative two days

    pain intensities in three category, namely static, dynamic and uterine cramping, gauged by a 100 mm visual analogue scale

Secondary outcomes

  1. Adverse effects

    Time frame: postoperative two days

    Incidences of epidural-related adverse effects including sedation states, sensory blockade, motor blockade, pruritus, nausea and vomiting

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Comparisons Between Low Thoracic and Lumbar Epidural Analgesia on Postoperative Pain Management Qualities After Cesarean Delivery: a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 13, 2019
Registry last updated
Jun 30, 2021

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.