The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Sham Local; Drug: Local anesthesia at incision site; Drug: Sham QL; Drug: QL

• Registration Number: NCT05480111
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-28
• Study First Submitted QC: 2022-07-27
• Study First Posted: 2022-07-29
• Study Start: 2022-09-07
• Primary Completion: 2023-02-24
• Study Completion: 2023-04-07
• Results First Submitted: 2024-02-24
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-09
• Last Update Submitted: 2024-05-09
• Results First Posted: 2024-06-05
• Last Update Posted: 2024-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QL Block	Sham Local	-
Local Anesthesia at incision site	Sham QL	-
QL Block	QL	-
Local Anesthesia at incision site	Local anesthesia at incision site	-

Primary Outcome Measures

Name	Time	Method
Physical Independence as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire	24 hours after anesthesia	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.
Physical Comfort as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire	24 hours after anesthesia	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.
Pain as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire	24 hours after anesthesia	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.
Psychological Support as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire	24 hours after anesthesia	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.
Emotional State as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire	24 hours after anesthesia	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.
Quality of Recovery as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire	24 hours after anesthesia	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

Secondary Outcome Measures

Name	Time	Method
Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)	6 weeks post surgery
Pain at Dynamic 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
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
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
Postoperative Nausea and Vomiting (PONV) Score Before Discharge	about 24 hours	Postoperative Nausea and Vomiting (PONV) score before discharge; Scale: (none, mild, moderate)
Time Needed to Administer the Intervention QL Block	Time to administration of intervention QL block

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States