Clinical trial NCT05480111: The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy
Official title: The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy: A Blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: laparoscopy
hysterectomy
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare quality of recovery as well as peri-operative systemic opiates use and pain scores in patients undergoing laparoscopic or robotic hysterectomy when local anesthetic versus Quadratus Lumborum nerve block (QL-2) is added to the standard pain management.


Eligibility criteria: Inclusion Criteria:

* English or Spanish speaking
* American Society of Anesthesiologists (ASA) physical status 1-3
* Planned laparoscopic or robotic hysterectomy

Exclusion Criteria:

* History of chronic pain requiring preoperative opioids, Known alcoholism disorder
* Congenital coagulopathy,
* Localized soft tissue infection,
* Use of anticoagulants,
* Dementia, inability or refusal to provide consent for the surgery
* Morbid obesity (BMI \> 50), due to expected technical difficulty to achieve the block

Primary outcomes:
measure: Pain as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
timeFrame: 24 hours after anesthesia
measure: Physical Comfort as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
timeFrame: 24 hours after anesthesia
measure: Physical Independence as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
timeFrame: 24 hours after anesthesia
measure: Psychological Support as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
timeFrame: 24 hours after anesthesia
measure: Emotional State as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
timeFrame: 24 hours after anesthesia
measure: Quality of Recovery as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
timeFrame: 24 hours after anesthesia
Secondary outcomes:
measure: Pain at Rest as Assessed by the Visual Analog Scale
timeFrame: Post anesthesia care unit (PACU) immediately postoperatively
measure: Pain at Rest as Assessed by the Visual Analog Scale
timeFrame: At the time of first opiate administration(upto one day after surgery)
measure: Pain at Rest as Assessed by the Visual Analog Scale
timeFrame: At the time of discharge (upto 3 days after surgery)
measure: Pain at Rest as Assessed by the Visual Analog Scale
timeFrame: Day 1 (24+/=4 hours post surgery)
measure: Pain at Dynamic as Assessed by the Visual Analog Scale
timeFrame: Day 1 (24+/=4 hours post surgery)
measure: Pain at Rest as Assessed by the Visual Analog Scale
timeFrame: Day 14 post surgery
measure: Pain at Dynamic as Assessed by the Visual Analog Scale
timeFrame: Day 14 post surgery
measure: Pain at Rest as Assessed by the Visual Analog Scale
timeFrame: 6 weeks post surgery
measure: Pain at Dynamic as Assessed by the Visual Analog Scale
timeFrame: 6 weeks post surgery
measure: Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)
timeFrame: in PACU(upto 8 hours after surgery)
measure: Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)
timeFrame: 24 hours after surgery
measure: Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)
timeFrame: 2 weeks post surgery
measure: Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)
timeFrame: 6 weeks post surgery
measure: Time to Administration of First Pain Medication in PACU
timeFrame: From entry to Post anesthesia care unit (PACU) to time to administration of first pain medication in PACU (about 75 minutes)
measure: Number of Participants With Complications Related to a Study Intervention
timeFrame: 30 days
measure: Postoperative Nausea and Vomiting (PONV) Score Before Discharge
timeFrame: about 24 hours
measure: Time Needed to Administer the Intervention QL Block
timeFrame: Time to administration of intervention QL block
Other outcomes:
measure: Number of Participants That Required Morcellation
timeFrame: Intraoperative (about 3 hours)
measure: Specimen Weight
timeFrame: inoperative (about 3 hours)
measure: Duration of Surgery
timeFrame: about 3 hours
measure: Number of Participants That Were Discharge on the Same Day
timeFrame: Hospital discharge (up to 24 hours)
measure: Number of Participants for Which Lysis of Adhesions Took Greater Than 30 Minutes
timeFrame: about 3 hours
measure: Number of Participants With Intraoperative Complications
timeFrame: Intraoperative (about 3 hours)
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: Randa J Jalloul, MD
role: PRINCIPAL_INVESTIGATOR
References: