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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

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Tracking Information

First Submitted Date ^ICMJE

October 2, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

November 1, 2018

Estimated Primary Completion Date

November 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Postoperative opioid consumption[ Time Frame: 2 hours postoperatively ]

Amount of opioid

Postoperative opioid consumption[ Time Frame: 6 hours postoperatively ]

Amount of opioid

Postoperative opioid consumption[ Time Frame: 24 hours postoperatively ]

Amount of opioid

Postoperative opioid consumption[ Time Frame: 48 hours postoperatively ]

Amount of opioid

Postoperative pain scores[ Time Frame: 2 hours postoperatively ]

VAS pain scores at rest and with movement 0-10

Postoperative pain scores[ Time Frame: 6 hours postoperatively ]

VAS pain scores at rest and with movement 0-10

Postoperative pain scores[ Time Frame: 24 hours postoperatively ]

VAS pain scores at rest and with movement 0-10

Postoperative pain scores[ Time Frame: 48 hours postoperatively ]

VAS pain scores at rest and with movement 0-10

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Amount of antipruritics[ Time Frame: 2 hours postoperatively ]
Amount of antipruritics required by patient
Amount of antipruritics[ Time Frame: 6 hours postoperatively ]
Amount of antipruritics required by patient
Amount of antipruritics[ Time Frame: 24 hours postoperatively ]
Amount of antipruritics required by patient
Amount of antipruritics[ Time Frame: 48 hours postoperatively ]
Amount of antipruritics required by patient
Amount of antiemetics[ Time Frame: 2 hours postoperatively ]
Amount of antiemetics required by patient
Amount of antiemetics[ Time Frame: 6 hours postoperatively ]
Amount of antiemetics required by patient
Amount of antiemetics[ Time Frame: 24 hours postoperatively ]
Amount of antiemetics required by patient
Amount of antiemetics[ Time Frame: 48 hours postoperatively ]
Amount of antiemetics required by patient
Overall satisfaction with pain control[ Time Frame: 1 week postoperatively ]
Rate overall satisfaction from 0-10

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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.
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.
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.

Study Arms

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.
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.
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.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

November 1, 2019

Estimated Primary Completion Date

November 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

Female

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

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

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Duke University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Amanda Kumar, MD Duke

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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