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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
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Laceration During Delivery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    July 17, 2023
    Last Updated
    October 23, 2023
    Sponsor
    Montefiore Medical Center
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    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

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    The PAIN (Pelvic Area Injection for Numbness) Study

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