The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05480111
• Other study ID #: HSC-MS-22-0158
• Status: Completed
• Phase: Phase 4
• Start date: September 7, 2022
• Est. completion date: April 7, 2023

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: April 7, 2023
• Est. primary completion date: February 24, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Local anesthesia at incision site
20 ml of 0.25% Bupivacaine will be given at incision site
• 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
• Sham Local
20 mls of normal saline given at incision site
• 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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants That Required Morcellation		Intraoperative (about 3 hours)
Other	Specimen Weight		inoperative (about 3 hours)
Other	Duration of Surgery		about 3 hours
Other	Number of Participants That Were Discharge on the Same Day		Hospital discharge (up to 24 hours)
Other	Number of Participants for Which Lysis of Adhesions Took Greater Than 30 Minutes		about 3 hours
Other	Number of Participants With Intraoperative Complications		Intraoperative (about 3 hours)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)		in PACU(upto 8 hours after surgery)
Secondary	Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)		24 hours after surgery
Secondary	Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)		2 weeks post surgery
Secondary	Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)		6 weeks post surgery
Secondary	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)
Secondary	Number of Participants With Complications Related to a Study Intervention		30 days
Secondary	Postoperative Nausea and Vomiting (PONV) Score Before Discharge	Postoperative Nausea and Vomiting (PONV) score before discharge; Scale: (none, mild, moderate)	about 24 hours
Secondary	Time Needed to Administer the Intervention QL Block		Time to administration of intervention QL block