The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy

Study Overview
=================
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.

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

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: Local anesthesia at incision site
* Drug: Sham QL
* Drug: Sham Local
* Drug: QL


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QL Block<br> | Drug: Sham Local<br>* 20 mls of normal saline given at incision site<br>Drug: QL<br>* 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<br>|
| Active Comparator: Local Anesthesia at incision site<br> | Drug: Local anesthesia at incision site<br>* 20 ml of 0.25% Bupivacaine will be given at incision site<br>Drug: Sham QL<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical comfort as assessed by the Quality of Recovery (QOR-40) validated questionnaire | 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 | 24 hours after anesthesia | 
| Physical independence as assessed by the Quality of Recovery (QOR-40) validated questionnaire | 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 | 24 hours after anesthesia | 
| Emotional state as assessed by the Quality of Recovery (QOR-40) validated questionnaire | 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 | 24 hours after anesthesia | 
| Psychological support as assessed by the Quality of Recovery (QOR-40) validated questionnaire | 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 | 24 hours after anesthesia | 
| Pain as assessed by the Quality of Recovery (QOR-40) validated questionnaire | 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 | 24 hours after anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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) | 
| 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) | 
| 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) | 
| 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 | 
| 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 | 
| Amount of oral morphine consumed measured in morphine milliequivalents (OME) |  | in PACU(upto 8 hours after surgery) | 
| Amount of oral morphine consumed measured in morphine milliequivalents (OME) |  | 24 hours after surgery | 
| Amount of oral morphine consumed measured in morphine milliequivalents (OME) |  | 2 weeks post surgery | 
| Amount of oral morphine consumed measured in morphine milliequivalents (OME) |  | 6 weeks post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopy, hysterectomy