Phase 4
N=76
The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT05480111 ↗Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Pain as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire — 30.0; 31.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Local anesthesia at incision site (Drug); Sham QL (Drug); Sham Local (Drug); QL (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire |
30.0; 31.1 | — |
| PRIMARY Physical Comfort as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire |
52.9; 54.3 | — |
| PRIMARY Physical Independence as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire |
20.4; 21.3 | — |
| PRIMARY Psychological Support as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire |
30.2; 30.3 | — |
| PRIMARY Emotional State as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire |
42.2; 42.1 | — |
| PRIMARY Quality of Recovery as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire |
175.6; 179.1 | — |
| SECONDARY Pain at Rest as Assessed by the Visual Analog Scale |
0; 1 | — |
| SECONDARY Pain at Rest as Assessed by the Visual Analog Scale |
0; 1 | — |
| SECONDARY Pain at Rest as Assessed by the Visual Analog Scale |
0; 1 | — |
| SECONDARY Pain at Rest as Assessed by the Visual Analog Scale |
0; 1 | — |
| SECONDARY Pain at Dynamic as Assessed by the Visual Analog Scale |
0.8; 1 | — |
| SECONDARY Pain at Rest as Assessed by the Visual Analog Scale |
0; 1 | — |
| SECONDARY Pain at Dynamic as Assessed by the Visual Analog Scale |
0.8; 1 | — |
| SECONDARY Pain at Rest as Assessed by the Visual Analog Scale |
0; 1 | — |
| SECONDARY Pain at Dynamic as Assessed by the Visual Analog Scale |
0.8; 1 | — |
| SECONDARY Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME) |
58.2; 60.69 | — |
| SECONDARY Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME) |
58.2; 60.69 | — |
| SECONDARY Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME) |
58.2; 60.69 | — |
| SECONDARY Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME) |
58.2; 60.69 | — |
| SECONDARY Time to Administration of First Pain Medication in PACU |
63.3; 88.7 | — |
| SECONDARY Number of Participants With Complications Related to a Study Intervention |
0; 0 | — |
| SECONDARY Postoperative Nausea and Vomiting (PONV) Score Before Discharge |
27; 24; 8; 9; 3; 2 | — |
| SECONDARY Time Needed to Administer the Intervention QL Block |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05480111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.