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Ultrasound-guided Pudendal Nerve Block for Pain After Hemorrhoidectomy

Primary Purpose

Hemorrhoids, Postoperative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pudendal nerve block
Placebo block
Sponsored by
Taipei Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhoids

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with symptomatic hemorrhoids (grade III and grade IV internal hemorrhoids, mixed hemorrhoids, and external hemorrhoids) Age 20 to 65 years old American Society of Anesthesiologists (ASA) classification I~III Receiving Ferguson hemorrhoidectomy under spinal anesthesia Exclusion Criteria: Allergy to local anesthetics or analgesics used in this study Drug abuse Coagulopathy An active infection at the injection site Patient refusal BMI ≥ 30 Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Pudendal block group

    Placebo group

    Arm Description

    Receiving bilateral pudendal nerve block with 0.5% ropivacaine (10 ml each side)

    Receiving bilateral pudendal nerve block with normal saline (10 ml each side)

    Outcomes

    Primary Outcome Measures

    Pain score on the numeric rating scale (NRS) at baseline
    NRS ranges from 0 (no pain) to 10 (worst pain)
    Postoperative pain score on the numeric rating scale (NRS) at 6 hours
    NRS ranges from 0 (no pain) to 10 (worst pain)
    Postoperative pain score on the numeric rating scale (NRS) at 12 hours
    NRS ranges from 0 (no pain) to 10 (worst pain)
    Postoperative pain score on the numeric rating scale (NRS) at 24 hours
    NRS ranges from 0 (no pain) to 10 (worst pain)
    Postoperative pain score on the numeric rating scale (NRS) at 48 hours
    NRS ranges from 0 (no pain) to 10 (worst pain)
    Postoperative pain score on the numeric rating scale (NRS) at 7 days
    NRS ranges from 0 (no pain) to 10 (worst pain)
    Opioid consumption at 6 hours
    Morphine equivalent dose
    Opioid consumption at 12 hours
    Morphine equivalent dose
    Opioid consumption at 24 hours
    Morphine equivalent dose
    Opioid consumption at 48 hours
    Morphine equivalent dose
    Opioid consumption at 7 days
    Morphine equivalent dose
    Quality of recovery at baseline
    Quality of recovery-15 questionnaire measures the baseline quality of recovery
    Quality of recovery at 24 hours
    Quality of recovery-15 questionnaire measures the quality of recovery after surgery
    Quality of recovery at 48 hours
    Quality of recovery-15 questionnaire measures the quality of recovery after surgery
    Quality of recovery at 7 days
    Quality of recovery-15 questionnaire measures the quality of recovery after surgery

    Secondary Outcome Measures

    Time to first rescue analgesics
    Time after hemorrhoidectomy
    Time to the first urination
    Time after hemorrhoidectomy
    Time to the first defecation
    Time after hemorrhoidectomy
    Patient satisfaction with pain control
    0 (worst) to 10 (Best)
    Postoperative complications
    Pudendal nerve block related complications

    Full Information

    First Posted
    May 2, 2023
    Last Updated
    June 3, 2023
    Sponsor
    Taipei Medical University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05889962
    Brief Title
    Ultrasound-guided Pudendal Nerve Block for Pain After Hemorrhoidectomy
    Official Title
    Effects of Ultrasound-guided Pudendal Nerve Block on Postoperative Pain and Quality of Recovery in Patients Undergoing Hemorrhoidectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    July 2024 (Anticipated)
    Study Completion Date
    September 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taipei Medical University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to investigate the effects of ultrasound-guided pudendal nerve block on postoperative pain, opioid consumption, and quality of recovery in patients receiving Ferguson hemorrhoidectomy.
    Detailed Description
    Patients who have symptomatic hemorrhoids undergoing Ferguson hemorrhoidectomy under spinal anesthesia will be randomized to receive bilateral ultrasound-guided pudendal nerve block with 0.5% ropivacaine or normal saline immediately after surgery. In addition, intravenous patient controlled analgesia, NSAIDs, and acetaminophen will be used in all participants for postoperative pain control. Postoperative pain on numerical rating scale (NRS), opioid consumption, quality of recovery (QOR-15), patient's satisfaction, and complications will be recorded at 6, 12, 24, 48 hours and 7 days after surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemorrhoids, Postoperative Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients are randomly allocated into pudendal block group or placebo group. Pudendal block group: Patients will receive pudendal nerve block with ropivacaine. Placebo group: Patients will receive pudendal nerve block with normal saline.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pudendal block group
    Arm Type
    Experimental
    Arm Description
    Receiving bilateral pudendal nerve block with 0.5% ropivacaine (10 ml each side)
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    Receiving bilateral pudendal nerve block with normal saline (10 ml each side)
    Intervention Type
    Procedure
    Intervention Name(s)
    Pudendal nerve block
    Intervention Description
    Patients who are randomized in the pudendal block group will receive bilateral pudendal nerve block with ropivacaine.
    Intervention Type
    Procedure
    Intervention Name(s)
    Placebo block
    Intervention Description
    Patients who are randomized in the placebo group will receive bilateral pudendal block with normal saline.
    Primary Outcome Measure Information:
    Title
    Pain score on the numeric rating scale (NRS) at baseline
    Description
    NRS ranges from 0 (no pain) to 10 (worst pain)
    Time Frame
    Baseline
    Title
    Postoperative pain score on the numeric rating scale (NRS) at 6 hours
    Description
    NRS ranges from 0 (no pain) to 10 (worst pain)
    Time Frame
    6 hours after hemorrhoidectomy
    Title
    Postoperative pain score on the numeric rating scale (NRS) at 12 hours
    Description
    NRS ranges from 0 (no pain) to 10 (worst pain)
    Time Frame
    12 hours after hemorrhoidectomy
    Title
    Postoperative pain score on the numeric rating scale (NRS) at 24 hours
    Description
    NRS ranges from 0 (no pain) to 10 (worst pain)
    Time Frame
    24 hours after hemorrhoidectomy
    Title
    Postoperative pain score on the numeric rating scale (NRS) at 48 hours
    Description
    NRS ranges from 0 (no pain) to 10 (worst pain)
    Time Frame
    48 hours after hemorrhoidectomy
    Title
    Postoperative pain score on the numeric rating scale (NRS) at 7 days
    Description
    NRS ranges from 0 (no pain) to 10 (worst pain)
    Time Frame
    7 days after hemorrhoidectomy
    Title
    Opioid consumption at 6 hours
    Description
    Morphine equivalent dose
    Time Frame
    6 hours after hemorrhoidectomy
    Title
    Opioid consumption at 12 hours
    Description
    Morphine equivalent dose
    Time Frame
    12 hours after hemorrhoidectomy
    Title
    Opioid consumption at 24 hours
    Description
    Morphine equivalent dose
    Time Frame
    24 hours after hemorrhoidectomy
    Title
    Opioid consumption at 48 hours
    Description
    Morphine equivalent dose
    Time Frame
    48 hours after hemorrhoidectomy
    Title
    Opioid consumption at 7 days
    Description
    Morphine equivalent dose
    Time Frame
    7 days after hemorrhoidectomy
    Title
    Quality of recovery at baseline
    Description
    Quality of recovery-15 questionnaire measures the baseline quality of recovery
    Time Frame
    Baseline
    Title
    Quality of recovery at 24 hours
    Description
    Quality of recovery-15 questionnaire measures the quality of recovery after surgery
    Time Frame
    24 hours after hemorrhoidectomy
    Title
    Quality of recovery at 48 hours
    Description
    Quality of recovery-15 questionnaire measures the quality of recovery after surgery
    Time Frame
    48 hours after hemorrhoidectomy
    Title
    Quality of recovery at 7 days
    Description
    Quality of recovery-15 questionnaire measures the quality of recovery after surgery
    Time Frame
    7 days after hemorrhoidectomy
    Secondary Outcome Measure Information:
    Title
    Time to first rescue analgesics
    Description
    Time after hemorrhoidectomy
    Time Frame
    Up to 7 days after hemorrhoidectomy
    Title
    Time to the first urination
    Description
    Time after hemorrhoidectomy
    Time Frame
    Up to 48 hours after hemorrhoidectomy
    Title
    Time to the first defecation
    Description
    Time after hemorrhoidectomy
    Time Frame
    Up to 48 hours after hemorrhoidectomy
    Title
    Patient satisfaction with pain control
    Description
    0 (worst) to 10 (Best)
    Time Frame
    24 hours after hemorrhoidectomy
    Title
    Postoperative complications
    Description
    Pudendal nerve block related complications
    Time Frame
    Up to 7 days after hemorrhoidectomy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with symptomatic hemorrhoids (grade III and grade IV internal hemorrhoids, mixed hemorrhoids, and external hemorrhoids) Age 20 to 65 years old American Society of Anesthesiologists (ASA) classification I~III Receiving Ferguson hemorrhoidectomy under spinal anesthesia Exclusion Criteria: Allergy to local anesthetics or analgesics used in this study Drug abuse Coagulopathy An active infection at the injection site Patient refusal BMI ≥ 30 Pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yuan-Wen Lee, MD, PhD
    Phone
    +886-2-27372181
    Ext
    8310
    Email
    m102093020@tmu.edu.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yuan-Wen Lee, MD, PhD
    Organizational Affiliation
    Taipei Medical University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Ultrasound-guided Pudendal Nerve Block for Pain After Hemorrhoidectomy

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