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

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03695172
Enrollment
12
Registered
2018-10-03
Start date
2019-09-12
Completion date
2021-03-20
Last updated
2022-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative, 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 If the epidural component of a combined spinal epidural anesthetic is used, the subject will be withdrawn from the study.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.

Interventions

DRUGRopivacaine

Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine

PROCEDURETAP 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.

BIOLOGICALQL 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.

PROCEDUREESP 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.

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Patients will be randomly assigned to one of three treatment groups, TAP, QL, or ESP blocks

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Opioid Consumption2 hours postoperativelyAmount of opioid in milligrams.
Postoperative Pain Scores2 hours postoperativelyVisual Analog Scale at rest with 0 being no pain and 10 being the worst pain imaginable

Secondary

MeasureTime frameDescription
Number of Participants Requiring Antipruritics2 hours postoperatively
Number of Participants Requiring Antiemetics2 hours postoperatively
Overall Satisfaction With Pain Control1 week postoperativelySatisfaction Rating, with 0 being not at all satisfied and 10 being completely satisfied

Countries

United States

Participant flow

Participants by arm

ArmCount
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. Ropivacaine: Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine 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.
4
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. Ropivacaine: Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine 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.
3
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. Ropivacaine: Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine 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.
3
Total10

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyWithdrawal by Subject110

Baseline characteristics

CharacteristicQL BlockESP BlockTotalTAP Block
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
3 Participants3 Participants10 Participants4 Participants
Age, Continuous28 years31.33 years32 years34.25 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants1 Participants5 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
1 Participants2 Participants4 Participants1 Participants
Region of Enrollment
United States
3 Participants3 Participants10 Participants4 Participants
Sex: Female, Male
Female
3 Participants3 Participants10 Participants4 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 40 / 30 / 3
other
Total, other adverse events
0 / 40 / 30 / 3
serious
Total, serious adverse events
0 / 40 / 30 / 3

Outcome results

Primary

Postoperative Opioid Consumption

Amount of opioid

Time frame: 48 hours postoperatively

ArmMeasureValue (MEAN)
TAP BlockPostoperative Opioid Consumption0 mg
QL BlockPostoperative Opioid Consumption38.3 mg
ESP BlockPostoperative Opioid Consumption15 mg
Primary

Postoperative Opioid Consumption

Amount of opioid

Time frame: 24 hours postoperatively

ArmMeasureValue (MEAN)
TAP BlockPostoperative Opioid Consumption0 mg
QL BlockPostoperative Opioid Consumption11.66 mg
ESP BlockPostoperative Opioid Consumption0 mg
Primary

Postoperative Opioid Consumption

Amount of opioid in milligrams.

Time frame: 2 hours postoperatively

ArmMeasureValue (MEAN)
TAP BlockPostoperative Opioid Consumption0 mg
QL BlockPostoperative Opioid Consumption0 mg
ESP BlockPostoperative Opioid Consumption0 mg
Primary

Postoperative Opioid Consumption

Amount of opioid

Time frame: 6 hours postoperatively

ArmMeasureValue (MEAN)
TAP BlockPostoperative Opioid Consumption0 mg
QL BlockPostoperative Opioid Consumption0 mg
ESP BlockPostoperative Opioid Consumption0 mg
Primary

Postoperative Pain Scores

Visual Analog Scale at rest with 0 being no pain and 10 being the worst pain imaginable

Time frame: 2 hours postoperatively

ArmMeasureValue (MEAN)
TAP BlockPostoperative Pain Scores.25 units on a scale
QL BlockPostoperative Pain Scores0 units on a scale
ESP BlockPostoperative Pain Scores.33 units on a scale
Primary

Postoperative Pain Scores

Visual Analog Scale at rest with 0 being no pain and 10 being the worst pain imaginable

Time frame: 6 hours postoperatively

ArmMeasureValue (MEAN)
TAP BlockPostoperative Pain Scores.25 units on a scale
QL BlockPostoperative Pain Scores0 units on a scale
ESP BlockPostoperative Pain Scores1 units on a scale
Primary

Postoperative Pain Scores

Visual Analog Scale at rest with 0 being no pain and 10 being the worst pain imaginable

Time frame: 24 hours postoperatively

ArmMeasureValue (MEAN)
TAP BlockPostoperative Pain Scores.75 units on a scale
QL BlockPostoperative Pain Scores2 units on a scale
ESP BlockPostoperative Pain Scores1 units on a scale
Primary

Postoperative Pain Scores

Visual Analog Scale at rest with 0 being no pain and 10 being the worst pain imaginable

Time frame: 48 hours postoperatively

ArmMeasureValue (MEAN)
TAP BlockPostoperative Pain Scores1.3 units on a scale
QL BlockPostoperative Pain Scores1.6 units on a scale
ESP BlockPostoperative Pain Scores3 units on a scale
Secondary

Number of Participants Requiring Antiemetics

Time frame: 48 hours postoperatively

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TAP BlockNumber of Participants Requiring Antiemetics2 Participants
QL BlockNumber of Participants Requiring Antiemetics1 Participants
ESP BlockNumber of Participants Requiring Antiemetics1 Participants
Secondary

Number of Participants Requiring Antiemetics

Time frame: 24 hours postoperatively

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TAP BlockNumber of Participants Requiring Antiemetics2 Participants
QL BlockNumber of Participants Requiring Antiemetics1 Participants
ESP BlockNumber of Participants Requiring Antiemetics2 Participants
Secondary

Number of Participants Requiring Antiemetics

Time frame: 6 hours postoperatively

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TAP BlockNumber of Participants Requiring Antiemetics2 Participants
QL BlockNumber of Participants Requiring Antiemetics0 Participants
ESP BlockNumber of Participants Requiring Antiemetics2 Participants
Secondary

Number of Participants Requiring Antiemetics

Time frame: 2 hours postoperatively

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TAP BlockNumber of Participants Requiring Antiemetics2 Participants
QL BlockNumber of Participants Requiring Antiemetics1 Participants
ESP BlockNumber of Participants Requiring Antiemetics1 Participants
Secondary

Number of Participants Requiring Antipruritics

Time frame: 2 hours postoperatively

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TAP BlockNumber of Participants Requiring Antipruritics0 Participants
QL BlockNumber of Participants Requiring Antipruritics0 Participants
ESP BlockNumber of Participants Requiring Antipruritics0 Participants
Secondary

Number of Participants Requiring Antipruritics

Time frame: 6 hours postoperatively

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TAP BlockNumber of Participants Requiring Antipruritics0 Participants
QL BlockNumber of Participants Requiring Antipruritics0 Participants
ESP BlockNumber of Participants Requiring Antipruritics0 Participants
Secondary

Number of Participants Requiring Antipruritics

Time frame: 24 hours postoperatively

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TAP BlockNumber of Participants Requiring Antipruritics0 Participants
QL BlockNumber of Participants Requiring Antipruritics3 Participants
ESP BlockNumber of Participants Requiring Antipruritics0 Participants
Secondary

Number of Participants Requiring Antipruritics

Time frame: 48 hours postoperatively

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TAP BlockNumber of Participants Requiring Antipruritics0 Participants
QL BlockNumber of Participants Requiring Antipruritics2 Participants
ESP BlockNumber of Participants Requiring Antipruritics0 Participants
Secondary

Overall Satisfaction With Pain Control

Satisfaction Rating, with 0 being not at all satisfied and 10 being completely satisfied

Time frame: 1 week postoperatively

Population: Date not collected.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026