The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy

The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy: A Blinded, Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Sham Local; Drug: QL; Drug: Local anesthesia at incision site; Drug: Sham QL

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QL Block	Drug: Sham Local; 20 mls of normal saline given at incision site; Drug: QL; QL block involves injection of 19 ml of 0.25% Bupivacaine and iml(4mg) of Decadron in a fascial place formed partly by the posterior surface of the quadratus lumborum muscle.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia
Active Comparator: Local Anesthesia at incision site	Drug: Local anesthesia at incision site; 20 ml of 0.25% Bupivacaine will be given at incision site; Drug: Sham QL; 20 mls of normal saline given at QL.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire	The QOR-40 questionnaire has 7 questions assessing pain with a maximum score of 35 and a minimum score of 5, a lower score indicating greater pain.	24 hours after anesthesia
Physical Comfort as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire	The QOR-40 questionnaire has 12 questions assessing physical comfort with a maximum score of 60 and a minimum score of 12, a lower score indicating a worst outcome.	24 hours after anesthesia
Physical Independence as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire	The QOR-40 questionnaire has 5 questions assessing physical independence, with a maximum score of 25 and a minimum score of 5, with a lower score indicating a worst outcome.	24 hours after anesthesia
Psychological Support as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire	The QOR-40 questionnaire has 7 questions assessing Psychological support, with a maximum score of 35 and a minimum score of 7, with a lower score indicating a worst outcome.	24 hours after anesthesia
Emotional State as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire	The QOR-40 questionnaire has 9 questions assessing emotional state, with a maximum score of 45 and a minimum score of 9, with a lower number indicating a worst outcome.	24 hours after anesthesia
Quality of Recovery as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire	The QOR-40 questionnaire has 40 questions with a total score from 40 (poorest quality of recovery) to 200 (best quality of recovery), with a higher score indicating a better outcome	24 hours after anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain at Rest as Assessed by the Visual Analog Scale	0 corresponding to no pain at all and 10 corresponding to worst imaginable pain	Post anesthesia care unit (PACU) immediately postoperatively
Pain at Rest as Assessed by the Visual Analog Scale	0 corresponding to no pain at all and 10 corresponding to worst imaginable pain	At the time of first opiate administration(upto one day after surgery)
Pain at Rest as Assessed by the Visual Analog Scale	0 corresponding to no pain at all and 10 corresponding to worst imaginable pain	At the time of discharge (upto 3 days after surgery)
Pain at Rest as Assessed by the Visual Analog Scale	0 corresponding to no pain at all and 10 corresponding to worst imaginable pain	Day 1 (24+/=4 hours post surgery)
Pain at Dynamic as Assessed by the Visual Analog Scale	0 corresponding to no pain at all and 10 corresponding to worst imaginable pain	Day 1 (24+/=4 hours post surgery)
Pain at Rest as Assessed by the Visual Analog Scale	0 corresponding to no pain at all and 10 corresponding to worst imaginable pain	Day 14 post surgery
Pain at Dynamic as Assessed by the Visual Analog Scale	0 corresponding to no pain at all and 10 corresponding to worst imaginable pain	Day 14 post surgery
Pain at Rest as Assessed by the Visual Analog Scale	0 corresponding to no pain at all and 10 corresponding to worst imaginable pain	6 weeks post surgery
Pain at Dynamic as Assessed by the Visual Analog Scale	0 corresponding to no pain at all and 10 corresponding to worst imaginable pain	6 weeks post surgery
Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)		in PACU(upto 8 hours after surgery)
Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)		24 hours after surgery
Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)		2 weeks post surgery
Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)		6 weeks post surgery
Time to Administration of First Pain Medication in PACU		From entry to Post anesthesia care unit (PACU) to time to administration of first pain medication in PACU (about 75 minutes)
Number of Participants With Complications Related to a Study Intervention		30 days
Postoperative Nausea and Vomiting (PONV) Score Before Discharge	Postoperative Nausea and Vomiting (PONV) score before discharge Scale: (none, mild, moderate)	about 24 hours
Time Needed to Administer the Intervention QL Block		Time to administration of intervention QL block

Other Outcome Measures

Outcome Measure	Time Frame
Number of Participants That Required Morcellation	Intraoperative (about 3 hours)
Specimen Weight	inoperative (about 3 hours)
Duration of Surgery	about 3 hours
Number of Participants That Were Discharge on the Same Day	Hospital discharge (up to 24 hours)
Number of Participants for Which Lysis of Adhesions Took Greater Than 30 Minutes	about 3 hours
Number of Participants With Intraoperative Complications	Intraoperative (about 3 hours)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Randa J Jalloul, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2022
• Primary Completion (Actual): February 24, 2023
• Study Completion (Actual): April 7, 2023

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: laparoscopy; hysterectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: HSC-MS-22-0158

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No