Vaginal Laceration During Delivery
Conditions
Brief summary
Postpartum pain can interfere with patient's ability to care for themselves, and their newborn, and untreated pain is associated with risk of greater opioid use, postpartum depression, and development of persistent pain. The research hypothesis of this study is that adding a locally injected analgesic, which will take effect once the epidural analgesia fades, may alleviate perineal pain and improve women's overall well-being and satisfaction. The objective of this study is to determine if prolonged analgesia and higher rate of maternal satisfaction are found when bupivacaine with epinephrine infiltration is used for perineal repair as compared to sham injection in patients with pre-existing effective epidural analgesia at time of perineal laceration repair.
Detailed description
Perineal lacerations, the disruption of the skin, mucosa and sometimes muscles that happen commonly during vaginal birth secondary to stretching of the introitus; are present in more than 75% of all vaginal deliveries. These lacerations can be classified based on the location and depth (layers injured). However, the classification of these lacerations does not correlate necessarily with postpartum pain. Severe lacerations, as those compromising the external or internal anal sphincter are less common and associated with more postpartum pain. It is common practice that only those lacerations causing bleeding, or distortion of normal pelvic anatomy are repaired. The repair of such lacerations at Montefiore Einstein is usually done using lidocaine for non-epiduralized patients; however, for patients with a functional epidural, no anesthetic agents are given locally to aid on long term pain control. The prevalence of perineal lacerations is more than 75% of all vaginal deliveries. The repair of such lacerations in the institution is usually done using lidocaine for non-epiduralized patients versus no local injection in patients with a pre-existing epidural analgesia. The prevalence of epidural analgesia use among women who underwent vaginal delivery in cross-sectional study of over 2 million deliveries in the United States was 71.1%. Once the analgesic effect of the epidural analgesia fades, the laceration may cause uncontrolled postpartum pain which can affect both the physical and mental recovery period, extend hospital stays, and increase the potential for serious adverse reactions with pain medications.
Interventions
DRUGBupivacaine
10 milliliters (ml) of bupivacaine 0.50% injected to the vaginal laceration site.
DRUGEpinephrine
Epinephrine (1:200,000) injected to the vaginal laceration site.
OTHERSham normal saline arm
10 milliliter (ml) of normal saline injected to the vaginal laceration site.
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Randomization will be blinded to the patient, the nurse carrying for the patient and providing the randomized, unlabeled syringe, the provider performing the perineal repair, the research team asking the maternal satisfaction questions, and the researcher analyzing the data. To assure blinding, the selection of the medication given, and the preparation of such medication will be performed by the labor and delivery anesthesia team. No one involved directly in the perineal laceration repair, or obtaining research information, nor the patient, will know what was injected. Subject treatment assignments will remain blinded until the final subject has completed follow up and all data has been recorded and validated. Urgent, immediate unblinding due to medical emergency may be authorized by the Investigator. When possible, the treatment assignment will be provided to the treating physician to maintain the blind for the Investigator and study staff.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy with a singleton pregnancy * English or Spanish speaking * Ongoing functioning epidural throughout the laceration repair * Multiparous or nulliparous * Ability to consent for themselves
Exclusion criteria
* Underwent an operative vaginal delivery and whose vaginal delivery was complicated by a postpartum hemorrhage * Have multiple gestations * Complaints of non-functioning epidural * Allergic to bupivacaine and/or epinephrine * Received an epidural top-off (bolus of local anesthetic injected into the epidural catheter) \< 3 hours from the perineal repair * Experienced extreme pain at time of study consent (pain scale score \> 3 on 0-10 scale)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Analgesic | Up to 24 hours after perineal laceration | The average time to first analgesic (TFA), in minutes, will be evaluated as the duration interval from injection to administration of the first analgesic, as applicable. |
| Maternal Satisfaction | 24 hours, 48 hours, and 7 days after perineal laceration | Maternal satisfaction will be assessed by participants' rating their ability to carry out their daily living activities. Participants will rate their ability to carry out these activities at 24 hours, 48 hours and 7 days using a 5-point scale (1 = very good; 2 = good; 3 = neutral; 4 = poor; or 5 = very poor) such that lower scores are indicative of increased ability to execute daily living activities. No descriptive statistics were completed given the small sample size. |
| Pain Score After Injection at Perineal Laceration | 24 hours, 48 hours, and 7 days after perineal laceration | Participants will self-report measures of symptoms using the Visual Analog Scale (VAS) to determine acute and chronic pain. Participants record a single handwritten mark at one point along the length of a 10-cm line that represents a continuum between the two ends of a scale where "no pain" is on the left end (0 cm) of the scale and the "worst pain" is on the right end of the scale (10 cm). Measurements from the starting point (left end) of the scale to the patients' marks are recorded in centimeters and are interpreted as the intensity of pain. The values will be used to track pain progression for a patient and to compare pain between patients with similar conditions. No descriptive statistics were completed given the small sample size. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFatima Estrada, MD, FACOG
Montefiore Medical Center
Participant flow
Pre-assignment details
From the time of consent to assignment to an arm, patients delivered. 19 patients were consented; however, 15 patients were not enrolled as they did not meet inclusion criteria after delivery and were not eligible for the study. In addition, 1 patient was not enrolled/randomized due to poorly functioning epidural. 3 patients were enrolled. Of the 3 patients who were randomized, 1 patient did not have the follow-up survey administered properly. Therefore, only 2 patients were evaluated.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 32 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 0 / 2 | 0 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
None listed