Clinical trial NCT04397458: Rescue Quadratus Lumborum Blocks for Post-cesarean Pain
Official title: Rescue Quadratus Lumborum Blocks for Post-cesarean Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Morphine
Analgesics
Analgesics, Opioid
Peripheral Nervous System Agents
Keywords: quadratus lumborum block
bupivacaine
cesarean delivery
c-section
intrathecal morphine
post-operative pain
post-cesarean analgesia
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess whether quadratus lumborum (QL) block performed 1 day after cesarean delivery will provide supplemental post-cesarean analgesia and reduce opioid requirements.


Eligibility criteria: Inclusion Criteria:

* elective or non-elective cesarean delivery on prior day
* pain scores \>5/10

Exclusion Criteria:

* BMI \>40
* obstructive sleep apnea
* drug abuse
* chronic pain
* chronic opioid use
* abdominal surgeries other than cesarean delivery
* contraindications to neuraxial or regional anesthesia
* received general anesthesia or did not receive neuraxial morphine for cesarean delivery

Primary outcomes:
measure: Total opioid consumption
timeFrame: 48 hours after intervention
Secondary outcomes:
measure: Amount of opioids used
timeFrame: at the time of intervention (one day following cesarean delivery)
measure: Amount of opioids used
timeFrame: 6 hours after intervention
measure: Amount of opioids used
timeFrame: 12 hours after intervention
measure: Amount of opioids used
timeFrame: 24 hours after intervention
measure: Amount of opioids used
timeFrame: 48 hours after intervention
measure: Time from quadratus lumborum block until first opioid request
timeFrame: from time of intervention until time of first opioid request (up to 48 hours)
measure: Pain as measured by an 11-point verbal pain score (at rest)
timeFrame: at the time of intervention (one day following cesarean delivery)
measure: Pain as measured by an 11-point verbal pain score (with movement)
timeFrame: at the time of intervention (one day following cesarean delivery)
measure: Pain as measured by an 11-point verbal pain score (at rest)
timeFrame: 6 hours after intervention
measure: Pain as measured by an 11-point verbal pain score (with movement)
timeFrame: 6 hours after intervention
measure: Pain as measured by an 11-point verbal pain score (at rest)
timeFrame: 12 hours after intervention
measure: Pain as measured by an 11-point verbal pain score (with movement)
timeFrame: 12 hours after intervention
measure: Pain as measured by an 11-point verbal pain score (at rest)
timeFrame: 24 hours after intervention
measure: Pain as measured by an 11-point verbal pain score (with movement)
timeFrame: 24 hours after intervention
measure: Pain as measured by an 11-point verbal pain score (at rest)
timeFrame: 48 hours after intervention
measure: Pain as measured by an 11-point verbal pain score (with movement)
timeFrame: 48 hours after intervention
measure: Nausea as measured by a 3-point scale
timeFrame: at the time of intervention (one day following cesarean delivery)
measure: Nausea as measured by a 3-point scale
timeFrame: 6 hours after intervention
measure: Nausea as measured by a 3-point scale
timeFrame: 12 hours after intervention
measure: Nausea, pruritus and sedation as measured by a 3-point scale
timeFrame: 24 hours after intervention
measure: Nausea as measured by a 3-point scale
timeFrame: 48 hours after intervention
measure: Pruritus as measured by a 3-point scale
timeFrame: at the time of intervention (one day following cesarean delivery)
measure: Pruritus as measured by a 3-point scale
timeFrame: 6 hours after intervention
measure: Pruritus as measured by a 3-point scale
timeFrame: 12 hours after intervention
measure: Pruritus as measured by a 3-point scale
timeFrame: 24 hours after intervention
measure: Pruritus as measured by a 3-point scale
timeFrame: 48 hours after intervention
measure: Sedation as measured by a 3-point scale
timeFrame: at the time of intervention (one day following cesarean delivery)
measure: Sedation as measured by a 3-point scale
timeFrame: 6 hours after intervention
measure: Sedation as measured by a 3-point scale
timeFrame: 12 hours after intervention
measure: Sedation as measured by a 3-point scale
timeFrame: 24 hours after intervention
measure: Sedation as measured by a 3-point scale
timeFrame: 48 hours after intervention
measure: Patient satisfaction as measured by the 5-point Likert scale
timeFrame: 48 hours after intervention
Other outcomes:
Locations:
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: Linden Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: