Quadratus Lumborum Block for Total Abdominal Hysterectomy

Study Overview
=================
Brief Summary
-----------------
Procedure specific postoperative pain management (PROSPECT) guidelines for abdominal hysterectomy published in 2006 recommended laparoscopic or vaginal hysterectomy as a preferred surgical technique. Multimodal postoperative pain management plane includes cyclooxygenase-2 (COX-2) selective inhibitors, and/or conventional non-steroidal antiinflammatory drugs (NSAID) in combination with strong opioids for high-intensity pain or with weak opioids for moderate- or low-intensity pain. Paracetamol also was recommended in combination with COX-2 inhibitors or conventional NSAIDs. Epidural analgesia was recommended for high-risk patients. PROSPECT guidelines updated in 2018 discuss only perioperative approach for laparoscopic hysterectomy. However, hysterectomy technique has been switched from total abdominal to laparoscopic approach. In low resources settings, laparoscopic technique is nor well developed neither available to many patients. Furthermore, the majority of patients undergo total abdominal hysterectomy (TAH), that is very painful procedure. Quadratus lumborum block (QLB) is a regional analgesic technique described by Blanco in 2007. Society for Obstetric Anesthesiology and Perinatology (SOAP) and European Society for Regional Anaesthesia and Pain Therapy (ESRA) recommended QLB for post-Cesarean pain management in cases where intrathecal morphine could not be used or for breakthrough pain. Previous reports have shown that QLB is effective in providing pain relief after various abdominal operations. The effects of QLB for laparoscopic hysterectomy is controversial. We would like to see if QLB can provide analgesic benefits in multimodal pain management after TAH in our clinical settings.

Detailed Description
-----------------
Participants will be randomly allocated into two groups. Experimental group will have QLB type 2 at the end of surgery, before emergence from general anesthesia. Control group will not have QLB. All cases will be done under general anesthesia. During the surgery, the patients will be monitored with 5-lead electrocardiography, pulse oximetry, non-invasive blood pressure and end-expiratory CO2. Standardized general anesthesia include induction with a propofol bolus of 1.5-2.5mg/kg and rocuronium 0.6mg/kg. Fentanyl 2 mcg/kg will be given at induction, and repeated to keep the blood pressure and heart rate changes up to 20% of baseline. Sevoflurane in a 50% air/50% oxygen mixture with an end-tidal of 1.5 vol% will be used as the maintenance agent. Mechanical ventilation will be maintained to keep the end-expiratory CO2 values between 34 and 36 mmHg. Incremental dose of rocuronium (0.15 mg/kg) will be given every 30 min or when needed. At the end of the surgery, after partial recovery from neuromuscular blockade, patients will receive atropine 0.01 mg/kg and neostigmine: 0.02mg/kg before tracheal extubation. Participants will be referred to the post-anesthesia recovery room after extubation and adequate hemodynamic and respiratory recovery. Postoperative pain management will include ketoprofen and morphine.

Official Title
-----------------
Quadratus Lumborum Block for Total Abdominal Hysterectomy: a Double-blind, Randomized, Controlled Trial

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

Intervention / Treatment
-----------------
* Procedure: QLB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: endometrial carcinoma or uterine fibroids American society of anesthesiologists (ASA) physical status 1-3, Participant's body weight > 50 kg, Written informed consent signed. Exclusion Criteria: Patient's refusal Allergies to any study medication Local skin infection on the site of QLB injection 3. Body mass index > 40 kg/m2 4. Inability to comprehend or participate in scoring scales 4. Deformations that could possibly affect the spread of the local anesthetic in the quadratus lumborum muscle plane 5. Quadratus lumborum muscle plane not seen in ultrasound examination 6. Patients on regular use of opioids 7. Psychiatric disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QLB group<br>At the end of surgery, before emergence of anesthesia, participants will receive bilateral QLB and intravenous (IV) ketoprofen 100 mg. Ketoprofen 100 mg IV will be repeated every 12 hours. For breakthrough pain patients will receive an IV bolus of morphine 5 mg. IV bolus can be repeated after 20 min. The maximum is 8 boluses for 4 hours. | Procedure: QLB<br>* QLB is ultrasound-guided injection of 30 ml bupivacaine 0.25% into quadratus lumborum plane posterior to the end of internal oblique muscle.<br>|
| No Intervention: Control group<br>At the end of surgery, before emergence of anesthesia, participants will receive IV ketoprofen 100 mg. Ketoprofen 100 mg IV will be repeated every 12 hours. For breakthrough pain patients will receive an IV bolus of morphine 5 mg. IV bolus can be repeated after 20 min. The maximum is 8 boluses for 4 hours. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption (mg) during the first 12 postoperative hours | Total dose of IV morphine that participants received during the first 12 hours after surgery | 12 hours after the end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at rest | Pain at rest at NRS (Numeric rating scale score 0-10) | 2, 6, 12, and 24 hours after surgery | 
| Pain at mobilization | Pain at mobilization at NRS (Numeric rating scale score 0-10) | 2, 6, 12, and 24 hours after surgery | 
| Cumulated morphine consumption (mg) at 24 hours postoperatively | Total dose of IV morphine that participants received during the first 24 hours after surgery | 24 hours after the end of surgery | 
| Time to first morphine demand | Time to first request for rescue analgesia (morphine) after the end of surgery | 24 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quadratus lumborum block, Postoperative analgesia