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.
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.
Brief Title
The PAIN (Pelvic Area Injection for Numbness) Study
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.
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
574-329-8771
Central Contact Email
ayeung@montefiore.org
Central Contact Role
Contact
Central Contact Phone
718-904-2767
Central Contact Email
festrada@montefiore.org
Completion Date
Completion Date Type
Estimated
Conditions
Vaginal Laceration During Delivery
Eligibility Criteria
Inclusion Criteria:
* \>= 18 years old
* 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
* Vaginal delivery was complicated by a postpartum hemorrhage
* Have multiple gestations
* Complaints of non-functional epidural
* Allergic to bupivacaine and/or epinephrine
* Epidural was a combined spinal-epidural (CSE)
* 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)
* \>= 18 years old
* 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
* Vaginal delivery was complicated by a postpartum hemorrhage
* Have multiple gestations
* Complaints of non-functional epidural
* Allergic to bupivacaine and/or epinephrine
* Epidural was a combined spinal-epidural (CSE)
* 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)
Inclusion Criteria
Inclusion Criteria:
* \>= 18 years old
* Healthy with a singleton pregnancy
* English or Spanish speaking
* Ongoing functioning epidural throughout the laceration repair
* Multiparous or nulliparous
* Ability to consent for themselves
* \>= 18 years old
* Healthy with a singleton pregnancy
* English or Spanish speaking
* Ongoing functioning epidural throughout the laceration repair
* Multiparous or nulliparous
* Ability to consent for themselves
Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05972681
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2023-14825
Overall Status
Recruiting
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Randomized Controlled Trial of Bupivacaine With Epinephrine for Local Pain Control Following Perineal Laceration Repair in Patients With Pre-existing Epidural Analgesia: The PAIN Trial
Primary Outcomes
Outcome Description
Average time to first analgesic (TFA) will be evaluated per patient as the duration interval following injection to administration of the first analgesic, as applicable.
Outcome Measure
Time to first analgesic
Outcome Time Frame
Up to 24 hours after perineal laceration
Outcome Description
Maternal satisfaction will be assessed by participants' rating their ability to carry out their daily living activities at 24hrs using a 4-point scale (very poor; poor; good; or very good)
Outcome Measure
Maternal Satisfaction
Outcome Time Frame
24 hours after perineal laceration
Outcome Description
Maternal satisfaction will be assessed by participants' rating their ability to carry out their daily living activities at 24hrs using a 4-point scale (very poor; poor; good; or very good)
Outcome Measure
Maternal Satisfaction
Outcome Time Frame
48 hours after perineal laceration
Outcome Description
Maternal satisfaction will be assessed by participants' rating their ability to carry out their daily living activities at 24hrs using a 4-point scale (very poor; poor; good; or very good)
Outcome Measure
Maternal Satisfaction
Outcome Time Frame
7 days after perineal laceration
Outcome Description
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
Outcome Measure
Pain score after injection at perineal laceration
Outcome Time Frame
Immediately and 24 hours after perineal laceration
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Fatima Estrada Trejo
Investigator Email
festrada@montefiore.org