Clinical trial NCT03534869: Auricular Acupuncture as Effective Pain Relief After Episiotomy
Official title: Auricular Acupuncture as Effective Pain Relief After Episiotomy: A Prospective Interventional Randomized Parallel Single-center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acupuncture, Ear
Episiotomy; Complications
Pain, Labor
Keywords: auricular acupuncture
episiotomy
acupuncture
pain relief
analgesic therapy
Lead sponsor: University Hospital Sestre Milosrdnice
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was designed as a prospective interventional randomized parallel longitudinal single-center study to evaluate the effects of auricular acupuncture on pain relief after episiotomy conducted in the Department of Gynecology and Obstetrics, University Hospital Center Sestre milosrdnice, Zagreb, Croatia. Prospective data were collected from November 2016 to April 2017. The study included healthy pregnant women over 18 years of age, a minimum of 36 weeks gestation that underwent mediolateral episiotomy during vaginal delivery. Sixty patients were included in the study. The patients were allocated either of the groups by using a heads-tails binary result coin toss method. Twenty-nine patients were treated with auricular acupuncture for episiotomy pain relief combined with oral analgesic therapy per request, while 31 patients were treated with oral analgesics per request only. In both groups, administration of oral analgesics was recorded.
Primary purpose: TREATMENT

Brief summary: Background: Episiotomy is performed in up to 30% of vaginal deliveries. Previously, pain treatment following episiotomy has relied on non-steroid anti-inflammatory drugs (NSAID) as analgesics, whose use during breastfeeding remains controversial due of their transfer to the child through lactation. The aim of the study is to determine the effect of acupuncture on postpartal perineal pain following episiotomy.

Methods: The study is designed as a prospective interventional randomized parallel single-center study to evaluate the effects of auricular acupuncture on pain relief after episiotomy. The population will encompass 60 patients that have had mediolateral episiotomy performed during vaginal delivery, with 29 receiving acupuncture therapy and 31 not receiving acupuncture therapy for pain relief. NSAID analgesic therapy will be made available per request.

Detailed description: Study Protocol The study is designed as a prospective interventional randomized parallel longitudinal single-center study to evaluate the effects of auricular acupuncture on pain relief after episiotomy conducted in the Department of Gynecology and Obstetrics, University Hospital Center Sestre milosrdnice, Zagreb, Croatia. This institution performs up to 3100 deliveries per year. Episiotomy is indicated and performed in 30% of them.

Prospective data will be collected from November 2016 to April 2017. The study will include healthy pregnant women over 18 years of age, a minimum of 36 weeks' gestation that underwent mediolateral episiotomy during vaginal delivery. Sixty patients will be included in the study. Half of patients will be treated with auricular acupuncture for episiotomy pain relief and oral analgesics, while the other half will be treated with oral analgesics only. In both groups, administration of oral analgesics was recorded. The patients will be allocated to the groups by using a heads-tails coin toss.

In this study, auricular acupuncture will be used. The acupuncture treatment consists of three acupuncture needles on the dominant ear according to French auriculotherapy guidelines - internal genital area, external genital area and Shen Men point that is used to increase the anaesthetic effect according to both French and Chinese traditions (14,15). Acupuncture needles will be stimulated by manual rotation of the needle to evoke needle sensation De Qi. No electrostimulation will be used. Sterile 0,2 x 1,4 mm needles were used. The needles will be inserted within 6-8 hours after childbirth by a certified acupuncturist. The needles will be left in place until the hospital discharge of the patient on the third postpartal day, and removed by a certified acupuncturist.

Additional oral analgesics (NSAID) could be supplied at any time upon patients request during hospitalization. Oral ibuprofen would be given as first line therapy, while oral paracetamol would be given as second line therapy.

Primary outcome measures will be pain intensity (VAS score) immediately after birth, 2 hours after birth, during the first 3 days-at rest and activity. Secondary outcome measures will be the need for analgesics, the amount of given analgesics, and the number of analgesic repetitions during the day.

In addition, subjective experiences of postpartum bleeding and pain due to uterine contractions will be recorded. For those who had received acupuncture therapy, pain levels at the acupuncture site, analysis of acupuncture related experience included discomfort during sleep, other contacts with acupuncture previously and likelihood of recommending the method to a friend will be noted. After leaving the hospital, women in the acupuncture group will be asked to fill out a questionnaire on acupuncture treatment satisfaction. All patients will sign an informed consent form. Inter-group comparisons will be performed based on the patient status at the time of hospital admission and during hospital stay. Input parameters: age, education level, number of previous births. Characteristics of delivery will be noted as: the time of birth, the duration of the birth, the subjective experience of the birth, the application of epidural analgesia.

If labor starts before 8 AM, it will be considered as the first day of the hospitalization, and if labor starts later than 8 AM, the first day of hospitalization will be documented as the next day.

Pain intensity will be evaluated using the Visual Analog Scala score. VAS score is scaled from 1 (smallest pain) to 10 (strongest pain). VAS score higher than 3 was the cut-off point for analgesic administration. The patients will be divided into two groups based on their education level; the first group encompassing women who had finished high school, and the other women who hold a university degree.

Statistical analysis The results will be expressed as a number for categorical variables and as a median value (25th-75th interquartile range) for continuous variables. Continuous variables will be compared using the Student's t-test for independent samples, while categorical variables were compared using χ2-test. Fisher's exact test will be used if expected frequencies are less than five. All statistical tests will be two tailed, and P values \< 0.05 considered statistically significant. All statistical analyses will be performed using MedCalc 9.5.1.0 (MedCalc Software, Mariakerke, Belgium).

Peer-reviewed publications containing data from the study have not yet been published.

Eligibility criteria: Inclusion Criteria:

* healthy pregnant women over 18 years of age
* a minimum of 36 weeks' gestation
* patients that underwent mediolateral episiotomy during vaginal delivery

Exclusion Criteria:

* any illness diagnosed during pregnancy
* unwillingness to submit to acupuncture therapy

Primary outcomes:
measure: Pain relief
timeFrame: Immediately after birth, 2 hours after birth, during the first 3 days-at rest and activity.
Secondary outcomes:
measure: Oral analgesics amount
timeFrame: First 3 postpartal days.
measure: Postpartum bleeding and pain due to uterine contractions
timeFrame: First 3 postpartal days.
measure: Number of analgesic repetitions during the day.
timeFrame: First 3 postpartal days.
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Center Sestre milosrdnice
Study officials:
affiliation: Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Center Sestre milosrdnice
name: Andro Košec, MD, PhD
role: STUDY_CHAIR
References: