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

Post-cesarean Pain Control Quality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03946982
• Other study ID #: 201902009RINC
• Status: Completed
• Phase: N/A
• Start date: May 28, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: May 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: April 30, 2021
• Est. primary completion date: March 27, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

Inclusion:

1. age between 20-yr and 50-yr parturients

2. elective cesarean delivery

Exclusion:

1. contraindicated to regional anesthesia, eg. coagulopathy (INR> 1.5; platelet< 80000...etc)

2. significant co-morbidities, eg. preeclamspia, heart failure with New York Heart Association (NYHA) Classification> class 2

3. allergy to opioids or local anesthetics

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-cesarean Pain Control Quality

Intervention

Procedure:
• low thoracic epidural
obstetric epidural catheters inserted at low thoracic intervertebral spaces
• lumbar epidural
obstetric epidural catheters inserted at low thoracic intervertebral spaces (conventional)

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of women with a visual analogue scale> 33 mm		postoperative two days
Primary	Pain intensity	pain intensities in three category, namely static, dynamic and uterine cramping, gauged by a 100 mm visual analogue scale	postoperative two days
Secondary	Adverse effects	Incidences of epidural-related adverse effects including sedation states, sensory blockade, motor blockade, pruritus, nausea and vomiting	postoperative two days