Clinical trial NCT04368364: A Randomized Control Trial Comparing Analgesic Benefits of Ultrasound-guided Single vs Continuous Quadratus Lumborum Blocks (QLB)vs Intrathecal Morphine(ITM) for Post Cesarean Section Pain
Official title: A Randomized Control Trial Comparing Analgesic Benefits of Ultrasound-guided Single vs Continuous Quadratus Lumborum Blocks vs Intrathecal Morphine for Post Cesarean Section Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: post c section pain
pain control after baby
nerve block for post delivery pain
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: the purpose of this study is to compare opioid consumption in morphine equivalents between the groups that received postoperative analgesia with intrathecal morphine versus US guided QL blocks versus US guided QL catheters


Eligibility criteria: Inclusion Criteria:

* Elective C section via Pfannenstiel incision
* Living singleton pregnancy
* Gestation week at least 37 weeks
* American Society of Anesthesiologists (ASA) status 1, 2 and 3
* Primary and secondary C sections

Exclusion Criteria:

* Chronic pain
* Opioid tolerant patients
* Allergy to drugs used in the study.
* Cognitive dysfunction
* BMI \> 40
* Coagulation disorder
* Local infection
* Inability to tolerate oral medication
* Previous intra-abdominal surgery
* Patients who will receive a combined spinal epidural for their C section
* Local anesthetics injected at any other fascial plane except the QLB plane (for e.g.- local wound infiltration by surgeon)
* Patients who received sedation or general anesthesia during their C section (midazolam, ketamine, fentanyl, propofol, hydromorphone)

Primary outcomes:
measure: Total Narcotic Consumption in Morphine Equivalents (in Milligrams)
timeFrame: upto 72 hours post surgery
Secondary outcomes:
measure: Total Narcotic Consumption in Morphine Equivalents (in Milligrams)
timeFrame: 12,24,48 hours post surgery
measure: Static Pain as Measured by the Numerical Pain Score (NPS)
timeFrame: 6, 12, 24, 48 and 72 hours post surgery
measure: Severity of Pruritus as Assessed by a Scale
timeFrame: 24, 48 and 72 hours post surgery
measure: Severity of Nausea as Assessed by a Scale
timeFrame: 24, 48 and 72 hours post surgery
measure: Severity of Vomiting as Assessed by a Scale
timeFrame: 24, 48 and 72 hours post surgery
measure: Severity of Sedation as Assessed by a Scale
timeFrame: 24, 48 and 72 hours post surgery
measure: Patient Satisfaction as Assessed by Likert Scale
timeFrame: 24 hours post surgery
measure: Dynamic Pain as Measured by the Numerical Pain Score (NPS)
timeFrame: 6, 12, 24, 48 and 72 hours post surgery
measure: Patient Satisfaction as Assessed by Likert Scale
timeFrame: 48 hours post surgery
measure: Patient Satisfaction as Assessed by Likert Scale
timeFrame: 72 hours post surgery
measure: Time to First Analgesic Request
timeFrame: 72 hours post surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital TMC
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sudipta Sen, MD
role: PRINCIPAL_INVESTIGATOR
References: