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Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03695172
Recruitment Status : Suspended (Suspended due to COVID-19)
First Posted : October 3, 2018
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
The purpose of this prospective single center, randomized study is to determine if ultrasound guided Transversus Abdominis Plane (TAP), Quadratus Lumborum (QL), and Erector Spinae Plane (ESP) blocks decrease opioid consumption in subjects undergoing elective cesarean section.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Cesarean Section Drug: Ropivacaine Procedure: TAP block Biological: QL block Procedure: ESP block Phase 4

Detailed Description:

The typical anesthetic for cesarean section at Duke University Hospital includes a spinal or combined spinal epidural anesthetic with intrathecal dosing of 1.4-1.6 mL bupivacaine HCl 0.75%, 15 mcg fentanyl, and 150 mcg morphine. If the epidural component of a combined spinal epidural anesthetic is used, the subject will be withdrawn from the study. Patients also receive rectal acetaminophen 975 mg prior to incision; intravenous (IV) ondansetron 4 mg, IV metoclopramide 10 mg, IV famotidine 20 mg and IV dexamethasone 4 mg intraoperatively; and IV ketorolac 15 mg prior to skin closure. There will be no change to this typical practice.

Patients who consent to be in this study will be randomized to receive one of three truncal nerve blocks using an online randomization program by the study PI (AK/EG): (1) ultrasound-guided bilateral classic TAP block; (2) ultrasound-guided bilateral anterior QL (also known as transmuscular or QL type 3) block; (3) ultrasound-guided bilateral ESP block at the level of T9. These nerve blocks will be performed after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side. Nerve blocks will be performed by a dedicated and trained group of regional anesthesiologists. This non-blinded regional anesthesiologist will save an ultrasound image after local anesthetic administration while the needle is still in position on each side. The study team will review these images to ensure a high quality of block performance.

Patients will have standard postoperative pain medication orders, including acetaminophen 975 mg PO Q6H for 4 days (scheduled, starting 6 hours after intraoperative rectal dose), ketorolac 15 mg IV Q6H for 24 hours (scheduled, starting 6 hours after intraoperative dose), ibuprofen 600 mg PO Q6H for 3 days (scheduled, starting 24 hours after first dose of ketorolac) and oxycodone 5-10mg PO Q3-4H PRN for 4 days. If patients are unable to tolerate oral medication or oxycodone is insufficient, rescue medications may be ordered: IV morphine 1-2 mg or IV hydromorphone 0.3-0.5 mg Q4H as needed. There is no change from the standard postoperative order sets used for patients after cesarean section.

Subjects' verbal pain scores at rest and with movement as well as opioid consumption will be recorded at 2, 6, 24, and 48 hours postoperatively. Additionally, the amount of antiemetics and antipruritics used will also be recorded at the above time points. These scores will be entered into a Duke University Hospital REDCap database. Subjects will also be sent a survey assessing their satisfaction with pain control one week after discharge via email or telephone. This information will be collected via Duke University Hospital REDCap.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomly assigned to one of three treatment groups, TAP, QL, or ESP blocks
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section
Actual Study Start Date : September 12, 2019
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : August 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: TAP block
Patients will receive bilateral TAP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.
Drug: Ropivacaine
Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine

Procedure: TAP block
Patient will receive bilateral TAP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.

Active Comparator: QL block
Patients will receive bilateral QL blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.
Drug: Ropivacaine
Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine

Biological: QL block
Patients will receive bilateral QL blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.

Active Comparator: ESP block
Patients will receive bilateral ESP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.
Drug: Ropivacaine
Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine

Procedure: ESP block
Patients will receive bilateral ESP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% of ropivacaine with epinephrine 1:400,000 per side.




Primary Outcome Measures :
  1. Postoperative opioid consumption [ Time Frame: 2 hours postoperatively ]
    Amount of opioid

  2. Postoperative opioid consumption [ Time Frame: 6 hours postoperatively ]
    Amount of opioid

  3. Postoperative opioid consumption [ Time Frame: 24 hours postoperatively ]
    Amount of opioid

  4. Postoperative opioid consumption [ Time Frame: 48 hours postoperatively ]
    Amount of opioid

  5. Postoperative pain scores [ Time Frame: 2 hours postoperatively ]
    VAS pain scores at rest and with movement 0-10

  6. Postoperative pain scores [ Time Frame: 6 hours postoperatively ]
    VAS pain scores at rest and with movement 0-10

  7. Postoperative pain scores [ Time Frame: 24 hours postoperatively ]
    VAS pain scores at rest and with movement 0-10

  8. Postoperative pain scores [ Time Frame: 48 hours postoperatively ]
    VAS pain scores at rest and with movement 0-10


Secondary Outcome Measures :
  1. Amount of antipruritics [ Time Frame: 2 hours postoperatively ]
    Amount of antipruritics required by patient

  2. Amount of antipruritics [ Time Frame: 6 hours postoperatively ]
    Amount of antipruritics required by patient

  3. Amount of antipruritics [ Time Frame: 24 hours postoperatively ]
    Amount of antipruritics required by patient

  4. Amount of antipruritics [ Time Frame: 48 hours postoperatively ]
    Amount of antipruritics required by patient

  5. Amount of antiemetics [ Time Frame: 2 hours postoperatively ]
    Amount of antiemetics required by patient

  6. Amount of antiemetics [ Time Frame: 6 hours postoperatively ]
    Amount of antiemetics required by patient

  7. Amount of antiemetics [ Time Frame: 24 hours postoperatively ]
    Amount of antiemetics required by patient

  8. Amount of antiemetics [ Time Frame: 48 hours postoperatively ]
    Amount of antiemetics required by patient

  9. Overall satisfaction with pain control [ Time Frame: 1 week postoperatively ]
    Rate overall satisfaction from 0-10



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:   Yes
Criteria

Inclusion Criteria:

  1. American Society of Anesthesiologists (ASA) Physical Status 1-3
  2. Age greater than or equal to 18 years
  3. Scheduled for elective cesarean section
  4. English speaking

Exclusion Criteria:

  1. ASA Physical Status 4-5
  2. Diagnosis of chronic pain
  3. Chronic opioid use (opioid use in the past 3 months)
  4. Preoperative use of SSRIs (Celexa, Lexapro, Prozac, Paxil), SNRIs (Cymbalta, Effexor), gabapentin, or pregabalin (Lyrica)
  5. Inability to cooperate with or understand protocol
  6. Inability to communicate pain scores or need for analgesia
  7. Infection at the site of block placement
  8. Intolerance or allergy to local anesthetics
  9. Neurologic deficit or disorder
  10. Blood thinning disorder or taking anticoagulant medication
  11. BMI > 50 kg/m2
  12. Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
  13. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance
  14. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course

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): NCT03695172


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Amanda Kumar, MD Duke
Publications:

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03695172    
Other Study ID Numbers: Pro00100742
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: November 2019
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.: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents