Epidural Analgesia on Electrophysiological Function

NCT02334150 | Completed Phase 2

• 2 other identifiers: NanningMCHJi-Juan Xing
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prolonged Labor; Healthy; Pelvic Floor Disorders

Keywords

combined spinal-epidural analgesia; pelvic floor muscle; postpartum electrophysiological function

Outcome Measures

Primary Outcomes (1)

• Muscle strength scores

  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 Outcomes (2)

• Degrees of muscle fatigue

  6 weeks

• The distribution of pelvic floor dynamic pressures

  6 weeks

Study Arms (2)

CSEA group

EXPERIMENTAL

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)

Control group

NO INTERVENTION

Women in the control group were not provided any analgesia during labor.

Interventions

CSEA (ropivocaine and sufentanil) DRUG

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.

Also known as: Combined spinal-epidural analgesia

CSEA group

Eligibility Criteria

• Age: 22 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing Maternity and Child Health Care Hospital: lead

Study Sites (1)

Maternal and Child Health Hospital of Nanning City

Nanning, Guangxi, 530021, China

Location

Related Publications (3)

• Frawley HC, Galea MP, Phillips BA, Sherburn M, Bo K. Effect of test position on pelvic floor muscle assessment. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Jun;17(4):365-71. doi: 10.1007/s00192-005-0016-3. Epub 2005 Oct 5.

  PMID: 16205845 BACKGROUND

• Caroci Ade S, Riesco ML, Sousa Wda S, Cotrim AC, Sena EM, Rocha NL, Fontes CN. Analysis of pelvic floor musculature function during pregnancy and postpartum: a cohort study: (a prospective cohort study to assess the PFMS by perineometry and digital vaginal palpation during pregnancy and following vaginal or caesarean childbirth). J Clin Nurs. 2010 Sep;19(17-18):2424-33. doi: 10.1111/j.1365-2702.2010.03289.x.

  PMID: 20920070 RESULT

• Xing JJ, Liu XF, Xiong XM, Huang L, Lao CY, Yang M, Gao S, Huang QY, Yang W, Zhu YF, Zhang DH. Effects of Combined Spinal-Epidural Analgesia during Labor on Postpartum Electrophysiological Function of Maternal Pelvic Floor Muscle: A Randomized Controlled Trial. PLoS One. 2015 Sep 4;10(9):e0137267. doi: 10.1371/journal.pone.0137267. eCollection 2015.

  PMID: 26340002 DERIVED

MeSH Terms

Conditions

Pelvic Floor Disorders

Interventions

Sufentanil

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ji-Juan Xing

  Maternal and Child Health Hospital of Nanning City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nanning Maternity and Child Health Care Hospital

Study Record Dates

• First Submitted: December 31, 2014
• First Posted: January 8, 2015
• Study Start: June 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 8, 2015

Record last verified: 2015-01

Locations

CN (1)