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Continuous Erector Spinae Plane Blocks to Treat Postoperative Pain After Open Gynecologic Procedures Via a Low Transverse (Pfannenstiel) Incision

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ClinicalTrials.gov Identifier: NCT05082155
Recruitment Status : Recruiting
First Posted : October 18, 2021
Last Update Posted : October 29, 2021
Sponsor:
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

Brief Summary:
Open gynecologic surgery can be very painful. With the goal of minimizing the use of opioids (with undesired side effects and potential for abuse), the investigators often administer a type of peripheral nerve block in which the investigators put local anesthetic-or, numbing medicine-near the nerves that go to the surgical area which helps to numb the area and decrease pain following surgery. These blocks with a single-injection of local anesthetic are called erector spinae plane (ESP) blocks, and they are applied on each side of the body since each injection affects only that one side. However, the numbing medication typically lasts for only 16-20 hours. For other peripheral nerve blocks, this duration can be increased with the insertion of a catheter-a tiny tube smaller than a piece of spaghetti-followed by an infusion of additional local anesthetic. However, the effects of the various peripheral nerve blocks are determined by the anatomy and physiology of the specific peripheral nerve, with an infusion resulting in dramatic benefits for one nerve yet having no effect for another. The potential benefits and risks of adding a catheter and subsequent local anesthetic infusion to a single-injection ESP block remain unknown. The investigatorstherefore propose a randomized, triple-masked, placebo-controlled, split-body clinical trial to determine the potential benefits and risks of adding the infusion to single-injection ESP blocks.

Condition or disease Intervention/treatment Phase
Surgical Incision Pain, Postoperative Pain, Acute Drug: Bupivacaine 0.25% Drug: Normal Saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a split-body study in which each study subject receives both treatments: one on each side of the body. Which treatment is applied to which side of the body is randomized (and masked).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The randomization list will be created by the University of California San Diego Investigational Drug Service. Investigational pharmacists will prepare all study solutions as determined by the randomization list. Bupivacaine and normal saline are indistinguishable in appearance, and therefore investigators, participants, and all clinical staff will be masked to treatment group assignment for the duration of the enrollment and data collection period. Unmasking will not occur until statistical analysis is complete (termed "triple masking").
Primary Purpose: Treatment
Official Title: Continuous Erector Spinae Plane Blocks to Treat Postoperative Pain After Open Gynecologic Procedures Via a Low Transverse (Pfannenstiel) Incision: A Randomized, Triple-masked, Placebo-controlled, Split-body Clinical Trial
Estimated Study Start Date : November 15, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Right sided catheter bupivacaine 0.25% and left sided catheter normal saline
This is a split body study. Bilateral erector spinae plane catheters will be inserted and study fluid is administered bilaterally. Bupivacaine 0.25 will be administered through the right-sided catheter while normal saline will be administered through the left-sided catheter. Both infusion pumps will be programmed to deliver a basal infusion of 1 mL/h and an automatic intermittent bolus of 20 mL every 4 hours.
Drug: Bupivacaine 0.25%
Bupivacaine 0.25% will be delivered as a basal infusion of 1 mL/h and an automatic intermittent bolus of 20 mL every 4 hours.

Drug: Normal Saline
Normal saline will be delivered as a basal infusion of 1 mL/h and an automatic intermittent bolus of 20 mL every 4 hours.
Other Name: Placebo

Experimental: Right sided catheter normal saline and left sided catheter bupivacaine 0.25%
This is a split body study. Bilateral erector spinae plane catheters will be inserted and study fluid is administered bilaterally. Normal saline will be administered through the right-sided catheter while bupivacaine 0.25% will be administered through the left-sided catheter. Both infusion pumps will be programmed to deliver a basal infusion of 1 mL/h and an automatic intermittent bolus of 20 mL every 4 hours.
Drug: Bupivacaine 0.25%
Bupivacaine 0.25% will be delivered as a basal infusion of 1 mL/h and an automatic intermittent bolus of 20 mL every 4 hours.

Drug: Normal Saline
Normal saline will be delivered as a basal infusion of 1 mL/h and an automatic intermittent bolus of 20 mL every 4 hours.
Other Name: Placebo




Primary Outcome Measures :
  1. "Average" pain during postoperative day 1 as measured using the numeric rating scale, collected postoperative day 1 for the time since midnight. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale [ Time Frame: Postoperative day 1 (00:01 through afternoon data-collection time point) ]
    The "average" pain measured using the numeric rating scale, collected postoperative day 1 for the time since midnight. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain


Secondary Outcome Measures :
  1. Maximum pain during postoperative day 1 which is the highest pain measured using the numeric rating scale, collected postoperative day 1 for the time since midnight. This is a 0-10 Likert scale measuring pain level with 0=no pain, 10=worst pain [ Time Frame: Postoperative day 1 (00:01 through afternoon data-collection time point) ]
    The highest pain measured using the numeric rating scale, collected postoperative day 1 for the time since midnight. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain

  2. Pain during coughing, postoperative day 1 which is the highest pain experienced during coughing using the numeric rating scale, collected postoperative day 1. This is a 0-10 Likert scale measuring pain level with 0= no pain and 10= worst pain [ Time Frame: Postoperative Day 1 at the time of the data collection time point ]
    The highest pain experienced during coughing using the numeric rating scale, collected postoperative day 1. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain

  3. "Average" pain during postoperative day 2 which is the "average" pain measured using the numeric rating scale, collected postoperative day 2 for the time since midnight. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10=worst pain [ Time Frame: Postoperative day 2 (00:01 through afternoon data-collection time point) ]
    The "average" pain measured using the numeric rating scale, collected postoperative day 2 for the time since midnight. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst pain

  4. Maximum pain during postoperative day 2 which is the highest pain experienced during coughing using the numeric rating scale, collected postoperative day 2. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain [ Time Frame: Postoperative day 2 (00:01 through afternoon data-collection time point) ]
    The highest pain experienced during coughing using the numeric rating scale, collected postoperative day 2. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain

  5. Pain during coughing, postoperative day 2 which is tthe highest pain experienced during coughing using the numeric rating scale, collected postoperative day 2. pain [ Time Frame: Postoperative Day 2 at the time of the data collection time point ]
    The highest pain experienced during coughing using the numeric rating scale, collected postoperative day 2. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain

  6. "Average" pain during postoperative day 3 which is the "average" pain measured using the numeric rating scale, collected postoperative day 3 for the time since midnight. It is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst pain [ Time Frame: Postoperative day 3 (00:01 through afternoon data-collection time point) ]
    The "average" pain measured using the numeric rating scale, collected the postoperative day 3 for the time since midnight. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain

  7. Maximum pain during postoperative day 3 which is the highest pain experienced during coughing using the numeric rating scale, collected postoperative day 3. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain [ Time Frame: Postoperative day 3 (00:01 through afternoon data-collection time point) ]
    The highest pain experienced during coughing using the numeric rating scale, collected postoperative day 3. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain

  8. Pain during coughing, postoperative day 3 which is the highest pain experienced during coughing using the numeric rating scale, collected postoperative day 3. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst pain [ Time Frame: Postoperative Day 3 at the time of the data collection phone call ]
    The highest pain experienced during coughing using the numeric rating scale, collected postoperative day 3. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain

  9. "Current" pain during postoperative days 1-3 which is the current pain experienced using the numeric rating scale, collected postoperative days 1-3. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain [ Time Frame: Postoperative Days 1-3 at the time of the data collection time point ]
    The current pain experienced using the numeric rating scale, collected postoperative days 1-3. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain

  10. Least pain during postoperative days 1-3 which is the lowest pain experienced since midnight using the numeric rating scale, collected postoperative days 1-3. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst pain [ Time Frame: Postoperative day1 1-3 (00:01 through afternoon data-collection time point) ]
    The lowest pain experienced since midnight using the numeric rating scale, collected postoperative days 1-3. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain


Other Outcome Measures:
  1. Surgical start time [ Time Frame: Day of surgery ]
    Time of day recorded using military time

  2. Surgical duration [ Time Frame: Day of surgery ]
    The duration from surgical start until stop measured in hours and minutes

  3. Indication for surgery [ Time Frame: Day of surgery ]
    Reason the patient underwent the surgical procedure [e.g., benign vs. malignant tumor]

  4. Opioid consumption [ Time Frame: Postoperative Days 0-3 ]
    Amount of opioids consumed daily and cumulatively measured in morphine equivalents

  5. Infusion duration [ Time Frame: Postoperative Days 0-3 ]
    The time from the end of surgery until the catheters were removed

  6. Hospital length of stay [ Time Frame: Postoperative Days 0-3 ]
    The day of discharge

  7. Antiemetic use [ Time Frame: Recovery room, postoperative days 0-2 ]
    Any antiemetic medication consumed

  8. Time to oral intake [ Time Frame: Postoperative Days 0-3 ]
    Day and time of first oral intake

  9. Time to flatus [ Time Frame: Postoperative Days 0-3 ]
    Day and time of first postoperative flatus

  10. Time to first bowel movement [ Time Frame: Postoperative Days 0-3 ]
    Day and time of first bowel movement

  11. Subjective weakness of hip flexion and/or knee extension [ Time Frame: Postoperative Days 1-3 ]
    If (yes or no) patient feels like the muscles that flex the hip and/or extend the knee joints are weak

  12. Number of participants with an intraoperative conversion to a vertical incision: study enrollment will be offered only to participants who are having a low, horizontal surgical incision; however, in rare cases the surgeons convert to a vertical incision [ Time Frame: Day of surgery ]
    If the surgeon made a vertical incision intraoperatively

  13. Number of participants with an inadvertent catheter dislodgment [ Time Frame: Postoperative Days 0-3 ]
    A catheter that was found dislodged from its original level at the skin



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Undergoing open gynecologic surgery via a low transverse incision;
  2. Analgesic plan includes bilateral single-injection ESP blocks; and
  3. Age 18 years or older.

Exclusion Criteria:

  1. Morbid obesity as defined by a body mass index > 40 (BMI=weight in kg / [height in meters]2);
  2. Renal insufficiency (abnormal preoperative creatinine or eGFR );
  3. Chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use > 4 weeks);
  4. History of opioid abuse;
  5. Any comorbidity which results in moderate or severe functional limitation;
  6. Inability to communicate with the investigators or hospital staff;
  7. Pregnancy;
  8. Planned intrathecal opioids;
  9. Incarceration;
  10. Known allergy to any study medication; and
  11. Any contraindication to perineural catheter insertion (e.g., infection at the catheter insertion site).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05082155


Contacts
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Contact: Brian M Ilfeld, MD,MS 8584445949 bilfeld@health.ucsd.edu
Contact: Engy Said, MD 619-543-6240 esaid@health.ucsd.edu

Locations
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United States, California
University Of California San Diego Recruiting
San Diego, California, United States, 92103
Contact: Brian M Ilfeld, MD,MS    858-444-5949    bilfeld@health.ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Brian M Ilfeld, MD,MS UCSD Medical Center
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Responsible Party: Brian M. Ilfeld, MD, MS, Professor of Anesthesiology, In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT05082155    
Other Study ID Numbers: Bilateral cESPB for GYN Surg
First Posted: October 18, 2021    Key Record Dates
Last Update Posted: October 29, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Pain, Postoperative
Acute Pain
Surgical Wound
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Wounds and Injuries
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents