The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy

NCT05480111 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HSC-MS-22-0158
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

laparoscopy; hysterectomy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (17)

• Pain at Rest as Assessed by the Visual Analog Scale

  Post anesthesia care unit (PACU) immediately postoperatively

• Pain at Rest as Assessed by the Visual Analog Scale

  At the time of first opiate administration(upto one day after surgery)

• Pain at Rest as Assessed by the Visual Analog Scale

  At the time of discharge (upto 3 days after surgery)

• Pain at Rest as Assessed by the Visual Analog Scale

  Day 1 (24+/=4 hours post surgery)

• Pain at Dynamic as Assessed by the Visual Analog Scale

  Day 1 (24+/=4 hours post surgery)

Other Outcomes (6)

• Number of Participants That Required Morcellation

  Intraoperative (about 3 hours)

• Specimen Weight

  inoperative (about 3 hours)

• Duration of Surgery

  about 3 hours

Study Arms (2)

QL Block

EXPERIMENTAL

Drug: Sham Local; Drug: QL

Local Anesthesia at incision site

ACTIVE COMPARATOR

Drug: Local anesthesia at incision site; Drug: Sham QL

Interventions

Local anesthesia at incision site DRUG

20 ml of 0.25% Bupivacaine will be given at incision site

Local Anesthesia at incision site

Sham QL DRUG

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

Local Anesthesia at incision site

Sham Local DRUG

20 mls of normal saline given at incision site

QL Block

QL DRUG

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

QL Block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Randa J Jalloul, MD
• Organization: The University of Texas Health Science Center at Houston

Randa.J.Jalloul@uth.tmc.edu

713-566-5749

Study Officials

• Randa J Jalloul, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 29, 2022
• Study Start: September 7, 2022
• Primary Completion: February 24, 2023
• Study Completion: April 7, 2023
• Last Updated: June 5, 2024
• Results First Posted: June 5, 2024

Record last verified: 2024-05

Locations

US (1)