Epidural Analgesia on Electrophysiological Function

January 7, 2015 updated by: Ji-Juan Xing, Nanjing Maternity and Child Health Care Hospital

Effects of Combined Spinal-epidural Analgesia During Labor on Postpartum Electrophysiological Function of Maternal Pelvic Floor Muscle: a Randomized Controlled Trial

Combined spinal-epidural analgesia (CSEA) is sometimes used for difficult births, but whether it contributes to postpartum pelvic muscle disorder is unclear. This randomized controlled trial examined whether CSEA affects the electrophysiological index of postpartum pelvic floor muscle during labor. The investigators plan to recruit 300 primiparous healthy women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Labor analgesia can relieve labor pain, reduce stress reactions, and improve blood supply to the fetus, benefiting mother and baby. Though traditional epidural analgesia has been used for more than 40 years, combined spinal-epidural analgesia (CSEA) has become popular because it provides faster-onset pain relief with minimal motor weakness. CSEA may also accelerate cervical dilation.

Despite the popularity of CSEA, whether it is associated with short- or long-term beneficial or adverse effects on mothers remains unclear. One question is whether the procedure affects the risk of female pelvic floor disorder (PFD), in which the pelvic floor muscles are injured. These muscles are responsible for supporting the pelvic organs and for stabilizing them during the rhythmic, strong labor contractions and for the diaphragm to contract enough to generate pressures of up to 19 kPa. Numerous risk factors have been associated with PFD, including obesity, diabetes, older age, connective tissue disorder, neurological disease, pregnancy, vaginal delivery and childbirth. PFD can lead in turn to stress urinary incontinence, overactive bladder, pelvic organ prolapse and fecal incontinence, all of which can strongly reduce women's physical and psychological health.

Pelvic floor function can be analyzed by measuring the strength and degree of fatigue of pelvic floor muscles, as well as the pelvic dynamic pressure. Abnormalities in these indicators appear even before patients complain of the signs and symptoms of PFD, making them a useful early diagnostic index.

In this randomized controlled study, we examined whether CSEA affects postpartum pelvic floor muscle function in primiparous mothers who give birth vaginally, as well as the duration of different stages of labor. Our results should help establish whether the widespread use of CSEA provides benefits to mothers or poses a risk.

Study Type

Interventional

Enrollment (Actual)

308

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Maternal and Child Health Hospital of Nanning City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Primiparous women gave birth by vaginal delivery between June 2013 and June 2014 in the Maternal and Child Health Hospital of Nanning
  • They were 22-30 years old
  • They were 155-165 cm tall
  • They were assigned a score of I or II on the American Society of Anesthesiologists scale
  • They gave birth by vaginal delivery to a live, single, mature fetus (≥ 38, ≤ 40 w) in the head position
  • A neonatal weight of 2900-3500 g

Exclusion Criteria:

  • History of chronic cough
  • Chronic constipation or pelvic organ resection
  • Family history of urinary incontinence
  • Pelvic organ prolapsus
  • Any systemic disease before delivery
  • A history of surgery, trauma, tumors or deformity of lumbar vertebrae

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CSEA group
Women in the CSEA group received CSEA during labor. An intravenous line was established when the uterine opening measured 1-2 cm. Then sufentanil (5-7 μg) was injected intrathecally. When the visual analogue pain score was 3 or higher, a mixture of ropivocaine (0.143%) and sufentanil (0.3 μg/ml) was continuously infused into the epidural space using an analgesia pump until the cervix was fully dilated. Load capacity was 5 ml. The analgesic plane was controlled under T10.
Drug: CSEA (ropivocaine and sufentanil)
Women in the CSEA group received CSEA during labor. An intravenous line was established when the uterine opening measured 1-2 cm. Then sufentanil (5-7 μg) was injected intrathecally. When the visual analogue pain score was 3 or higher, a mixture of ropivocaine (0.143%) and sufentanil (0.3 μg/ml) was continuously infused into the epidural space using an analgesia pump until the cervix was fully dilated. Load capacity was 5 ml. The analgesic plane was controlled under T10.
Other Names:
  • Combined spinal-epidural analgesia
No Intervention: Control group
Women in the control group were not provided any analgesia during labor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strength scores
Time Frame: 6 weeks
The postpartum strength of pelvic floor muscles was measured with subjects in the supine lithotomy position. A vaginal manometric probe with a balloon was sheathed with a condom and placed into the vagina; the top of the device lay at the bottom of the vagina before air inflation. The other side of the probe was connected to the PHENIX muscle stimulator. Muscle strength was assessed using the international muscle strength detection method, which features a strength scale from 0 to 5. The strength score depends on whether vaginal muscle contraction upon stimulation fails to occur (0 points) or lasts 1 second (1 point), 2 seconds (2 points) and so on. If the contraction lasts 5 seconds or more, a strength score of 5 is assigned.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degrees of muscle fatigue
Time Frame: 6 weeks
Degree of muscle fatigue was considered normal if 0%, abnormal if <0%.
6 weeks
The distribution of pelvic floor dynamic pressures
Time Frame: 6 weeks
Pelvic floor dynamic pressure was considered normal when it fell between 80 and 150 cm H2O.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Maternity and Child Health Care Hospital

Investigators

  • Principal Investigator: Ji-Juan Xing, Maternal and Child Health Hospital of Nanning City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

December 31, 2014

First Submitted That Met QC Criteria

January 7, 2015

First Posted (Estimate)

January 8, 2015

Study Record Updates

Last Update Posted (Estimate)

January 8, 2015

Last Update Submitted That Met QC Criteria

January 7, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NanningMCH
  • Ji-Juan Xing (Registry Identifier: CSEAEF)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on CSEA (ropivocaine and sufentanil)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe