The PAIN (Pelvic Area Injection for Numbness) Study
Primary Purpose
Vaginal Laceration During Delivery
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bupivacaine and epinephrine
Sham normal saline arm
Sponsored by
About this trial
This is an interventional treatment trial for Vaginal Laceration During Delivery
Eligibility Criteria
Inclusion Criteria: >= 18 years old Healthy with a singleton pregnancy English or Spanish speaking Ability to consent for themselves Exclusion Criteria: Women who underwent an operative vaginal delivery and whose vaginal delivery was complicated by a postpartum hemorrhage Multiple gestation
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Local Anesthesia arm
Normal saline sham arm
Arm Description
Bupivicaine and Epinephrine
Outcomes
Primary Outcome Measures
Time to first analgesic
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.
Maternal Satisfaction
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)
Maternal Satisfaction
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)
Maternal Satisfaction
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)
Pain score after injection at 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
Secondary Outcome Measures
Full Information
NCT ID
NCT05972681
First Posted
July 17, 2023
Last Updated
October 23, 2023
Sponsor
Montefiore Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05972681
Brief Title
The PAIN (Pelvic Area Injection for Numbness) Study
Official Title
A Randomized Controlled Trial of Bupivacaine for Local Pain Control Following Perineal Laceration Repair in Patients With Pre-existing Epidural Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The prevalence of perineal lacerations is more than 75% of all vaginal deliveries. The repair of such lacerations in our 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.
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 proposed trial is a two-arm, single-masked, prospective randomized superiority control trial. Women with a working epidural analgesia, and status post a vaginal delivery involving a second-degree laceration will be invited to participate. Women in the local anesthesia (LA) arm will get a LA injected to the laceration and women in the sham arm will get an injection with saline. The differences in perineal pain between the groups will be evaluated at time of the first analgesic (TFA) demand, maternal satisfaction at 24 hours, and visual analog scale (VAS) pain score.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Laceration During Delivery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Local Anesthesia arm
Arm Type
Experimental
Arm Description
Bupivicaine and Epinephrine
Arm Title
Normal saline sham arm
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
Bupivacaine and epinephrine
Intervention Description
Women in the bupivacaine and epinephrine arm will get 10 milliliters (ml) of bupivacaine with epinephrine injected to the vaginal laceration site.
Intervention Type
Other
Intervention Name(s)
Sham normal saline arm
Intervention Description
Women in the sham normal saline arm will get 10 milliliter (ml) of normal saline injected to the vaginal laceration site.
Primary Outcome Measure Information:
Title
Time to first analgesic
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.
Time Frame
Up to 24 hours after perineal laceration
Title
Maternal Satisfaction
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)
Time Frame
24 hours after perineal laceration
Title
Maternal Satisfaction
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)
Time Frame
48 hours after perineal laceration
Title
Maternal Satisfaction
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)
Time Frame
7 days after perineal laceration
Title
Pain score after injection at perineal laceration
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
Time Frame
Immediately and 24 hours after perineal laceration
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
>= 18 years old
Healthy with a singleton pregnancy
English or Spanish speaking
Ability to consent for themselves
Exclusion Criteria:
Women who underwent an operative vaginal delivery and whose vaginal delivery was complicated by a postpartum hemorrhage
Multiple gestation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clarissa P Diniz, MD
Phone
718-904-2767
Email
cdiniz@montefiore.org
First Name & Middle Initial & Last Name or Official Title & Degree
Fatima Estrada, MD
Phone
718-904-2767
Email
festrada@montefiore.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The PAIN (Pelvic Area Injection for Numbness) Study
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