Pain, Postoperative, Cesarean Section
Conditions
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 If the epidural component of a combined spinal epidural anesthetic is used, the subject will be withdrawn from the study.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
Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine
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.
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.
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
Study design
Intervention model description
Patients will be randomly assigned to one of three treatment groups, TAP, QL, or ESP blocks
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Opioid Consumption | 2 hours postoperatively | Amount of opioid in milligrams. |
| Postoperative Pain Scores | 2 hours postoperatively | Visual Analog Scale at rest with 0 being no pain and 10 being the worst pain imaginable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Requiring Antipruritics | 2 hours postoperatively | — |
| Number of Participants Requiring Antiemetics | 2 hours postoperatively | — |
| Overall Satisfaction With Pain Control | 1 week postoperatively | Satisfaction Rating, with 0 being not at all satisfied and 10 being completely satisfied |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | QL Block | ESP Block | Total | TAP Block |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants | 10 Participants | 4 Participants |
| Age, Continuous | 28 years | 31.33 years | 32 years | 34.25 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 4 Participants | 1 Participants |
| Region of Enrollment United States | 3 Participants | 3 Participants | 10 Participants | 4 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 10 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 0 / 4 | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 4 | 0 / 3 | 0 / 3 |
Outcome results
Postoperative Opioid Consumption
Amount of opioid
Time frame: 48 hours postoperatively
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TAP Block | Postoperative Opioid Consumption | 0 mg |
| QL Block | Postoperative Opioid Consumption | 38.3 mg |
| ESP Block | Postoperative Opioid Consumption | 15 mg |
Postoperative Opioid Consumption
Amount of opioid
Time frame: 24 hours postoperatively
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TAP Block | Postoperative Opioid Consumption | 0 mg |
| QL Block | Postoperative Opioid Consumption | 11.66 mg |
| ESP Block | Postoperative Opioid Consumption | 0 mg |
Postoperative Opioid Consumption
Amount of opioid in milligrams.
Time frame: 2 hours postoperatively
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TAP Block | Postoperative Opioid Consumption | 0 mg |
| QL Block | Postoperative Opioid Consumption | 0 mg |
| ESP Block | Postoperative Opioid Consumption | 0 mg |
Postoperative Opioid Consumption
Amount of opioid
Time frame: 6 hours postoperatively
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TAP Block | Postoperative Opioid Consumption | 0 mg |
| QL Block | Postoperative Opioid Consumption | 0 mg |
| ESP Block | Postoperative Opioid Consumption | 0 mg |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TAP Block | Postoperative Pain Scores | .25 units on a scale |
| QL Block | Postoperative Pain Scores | 0 units on a scale |
| ESP Block | Postoperative Pain Scores | .33 units on a scale |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TAP Block | Postoperative Pain Scores | .25 units on a scale |
| QL Block | Postoperative Pain Scores | 0 units on a scale |
| ESP Block | Postoperative Pain Scores | 1 units on a scale |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TAP Block | Postoperative Pain Scores | .75 units on a scale |
| QL Block | Postoperative Pain Scores | 2 units on a scale |
| ESP Block | Postoperative Pain Scores | 1 units on a scale |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TAP Block | Postoperative Pain Scores | 1.3 units on a scale |
| QL Block | Postoperative Pain Scores | 1.6 units on a scale |
| ESP Block | Postoperative Pain Scores | 3 units on a scale |
Number of Participants Requiring Antiemetics
Time frame: 48 hours postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAP Block | Number of Participants Requiring Antiemetics | 2 Participants |
| QL Block | Number of Participants Requiring Antiemetics | 1 Participants |
| ESP Block | Number of Participants Requiring Antiemetics | 1 Participants |
Number of Participants Requiring Antiemetics
Time frame: 24 hours postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAP Block | Number of Participants Requiring Antiemetics | 2 Participants |
| QL Block | Number of Participants Requiring Antiemetics | 1 Participants |
| ESP Block | Number of Participants Requiring Antiemetics | 2 Participants |
Number of Participants Requiring Antiemetics
Time frame: 6 hours postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAP Block | Number of Participants Requiring Antiemetics | 2 Participants |
| QL Block | Number of Participants Requiring Antiemetics | 0 Participants |
| ESP Block | Number of Participants Requiring Antiemetics | 2 Participants |
Number of Participants Requiring Antiemetics
Time frame: 2 hours postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAP Block | Number of Participants Requiring Antiemetics | 2 Participants |
| QL Block | Number of Participants Requiring Antiemetics | 1 Participants |
| ESP Block | Number of Participants Requiring Antiemetics | 1 Participants |
Number of Participants Requiring Antipruritics
Time frame: 2 hours postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAP Block | Number of Participants Requiring Antipruritics | 0 Participants |
| QL Block | Number of Participants Requiring Antipruritics | 0 Participants |
| ESP Block | Number of Participants Requiring Antipruritics | 0 Participants |
Number of Participants Requiring Antipruritics
Time frame: 6 hours postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAP Block | Number of Participants Requiring Antipruritics | 0 Participants |
| QL Block | Number of Participants Requiring Antipruritics | 0 Participants |
| ESP Block | Number of Participants Requiring Antipruritics | 0 Participants |
Number of Participants Requiring Antipruritics
Time frame: 24 hours postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAP Block | Number of Participants Requiring Antipruritics | 0 Participants |
| QL Block | Number of Participants Requiring Antipruritics | 3 Participants |
| ESP Block | Number of Participants Requiring Antipruritics | 0 Participants |
Number of Participants Requiring Antipruritics
Time frame: 48 hours postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAP Block | Number of Participants Requiring Antipruritics | 0 Participants |
| QL Block | Number of Participants Requiring Antipruritics | 2 Participants |
| ESP Block | Number of Participants Requiring Antipruritics | 0 Participants |
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.