The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05480111
• Collaborator: (none)
• Enrollment: 76
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36.1
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: Local anesthesia at incision site; Drug: Sham QL; Drug: Sham Local; Drug: QL	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Supportive Care
• Official Title: The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy: A Blinded, Randomized Controlled Trial
• Anticipated Study Start Date: Jul 27, 2022
• Anticipated Primary Completion Date: Jul 31, 2024
• Anticipated Study Completion Date: Jul 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Physical comfort as assessed by the Quality of Recovery (QOR-40) validated questionnaire [24 hours after anesthesia]

   The QOR-40 questionnaire has 40 questions each one is scored from 1(none of the time) to 5(all of the time) for a total score of 200 a higher number indicating better quality

2. Physical independence as assessed by the Quality of Recovery (QOR-40) validated questionnaire [24 hours after anesthesia]

   The QOR-40 questionnaire has 40 questions each one is scored from 1(none of the time) to 5(all of the time) for a total score of 200 a higher number indicating better quality

3. Emotional state as assessed by the Quality of Recovery (QOR-40) validated questionnaire [24 hours after anesthesia]

   The QOR-40 questionnaire has 40 questions each one is scored from 1(none of the time) to 5(all of the time) for a total score of 200 a higher number indicating better quality

4. Psychological support as assessed by the Quality of Recovery (QOR-40) validated questionnaire [24 hours after anesthesia]

   The QOR-40 questionnaire has 40 questions each one is scored from 1(none of the time) to 5(all of the time) for a total score of 200 a higher number indicating better quality

5. Pain as assessed by the Quality of Recovery (QOR-40) validated questionnaire [24 hours after anesthesia]

   The QOR-40 questionnaire has 40 questions each one is scored from 1(none of the time) to 5(all of the time) for a total score of 200 a higher number indicating better quality

Secondary Outcome Measures

1. Pain at rest as assessed by the visual analog scale [Post anesthesia care unit (PACU) immediately postoperatively]

   0 corresponding to no pain at all and 10 corresponding to worst imaginable pain

2. Pain at rest as assessed by the visual analog scale [At the time of first opiate administration(upto one day after surgery)]

   0 corresponding to no pain at all and 10 corresponding to worst imaginable pain

3. Pain at rest as assessed by the visual analog scale [At the time of discharge (upto 3 days after surgery)]

   0 corresponding to no pain at all and 10 corresponding to worst imaginable pain

4. Pain at rest as assessed by the visual analog scale [Day 1 (24+/=4 hours post surgery)]

   0 corresponding to no pain at all and 10 corresponding to worst imaginable pain

5. Pain at rest as assessed by the visual analog scale [Day 14 post surgery]

   0 corresponding to no pain at all and 10 corresponding to worst imaginable pain

6. Pain at rest as assessed by the visual analog scale [6 weeks post surgery]

   0 corresponding to no pain at all and 10 corresponding to worst imaginable pain

7. Amount of oral morphine consumed measured in morphine milliequivalents (OME) [in PACU(upto 8 hours after surgery)]

8. Amount of oral morphine consumed measured in morphine milliequivalents (OME) [24 hours after surgery]

9. Amount of oral morphine consumed measured in morphine milliequivalents (OME) [2 weeks post surgery]

10. Amount of oral morphine consumed measured in morphine milliequivalents (OME) [6 weeks post surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Randa Jalloul, Associate Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT05480111
• Other Study ID Numbers: HSC-MS-22-0158
• First Posted: Jul 29, 2022
• Last Update Posted: Jul 29, 2022
• Last Verified: Jul 1, 2022

• 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
• Keywords provided by Randa Jalloul, Associate Professor, The University of Texas Health Science Center, Houston: laparoscopy; hysterectomy
• Additional relevant MeSH terms: Pain, Postoperative; Anesthetics

Study Results

No Results Posted as of Jul 29, 2022