Post Hysterectomy Pain Prevention: Pre-op Wound Infiltration With Anesthetic Protocol Versus Standard of Care

Study Overview
=================
Brief Summary
-----------------
The study is a blinded randomized clinical trial, comparing policies of high volume preemptive wound infiltration with a specific anesthetic cocktail versus standard of care (no wound infiltration and routine anesthesia) for post operative pain management after hysterectomy. Morphine use and pain will be measured during index admission, and pain will also be measured six weeks postoperatively. The study will be conducted at a single site, Rockyview General Hospital.

Official Title
-----------------
Post Hysterectomy Pain Prevention: Randomized Clinical Trial of High Volume Preoperative Wound Infiltration and Pain Specific Anesthetic Protocol Versus Standard of Care (no Wound Infiltration and Routine Anesthetic Protocol)

Conditions
-----------------
Hysterectomy

Intervention / Treatment
-----------------
* Procedure: Standard of care
* Procedure: Pre-emptive wound infiltration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women may be included if they require total abdominal hysterectomies (+/- BSO) at Rockyview hospital. Exclusion Criteria: have endometrial cancer, require a vertical midline incision, have any additional surgery planned have a contraindication to morphine, Magnesium Sulfate, Dexmethasone, Lidocaine or Marcaine have difficulty communicating in English

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>Current Standard of Care at Rockyview General Hospital for Post Hysterectomy Pain Prevention(no wound infiltration and routine anesthetic protocol). | Procedure: Standard of care<br>* Current Standard of Care at Rockyview General Hospital for Post Hysterectomy Pain Prevention(no wound infiltration and routine anesthetic protocol).<br>|
| Experimental: Pre-emptive wound infiltration<br>The Wound Infiltration Group will receive 100 mL 0.25% marcaine plain distributed as follows: 50 mL subcutaneously prior to skin incision along entire length of planned incision line, 50 mL subfascially prior to fascial incision, with 10 mL infiltrated directly into the rectus muscles bilaterally. | Procedure: Pre-emptive wound infiltration<br>* The Wound Infiltration Group will receive 100 mL 0.125% marcaine plain distributed as follows: 50 mL subcutaneously prior to skin incision along entire length of planned incision line, 50 mL subfascially prior to fascial incision, with 10 mL infiltrated directly into the rectus muscles bilaterally. The Anesthetic will be given as determined appropriate to the patient by the staff anesthetist with the addition of the following: 2 grams of Magnesium Sulphate, 10 mg of Dexamethasone, and 3 mg/kg of Lidocaine, half of which is given on induction and half of which is infused throughout the remainder of the case.<br>* Other names: Lidocaine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Morphine | The amount of post operative morphine (PCA IV) will be recorded from the PCA device each day by the Acute Pain Service Nurses. The total dose (mg morphine) will be recorded for each 24 hour period, and summed for the complete postoperative period of admission. | For the entire post-operative hospital admission (3 days on average) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measurement using Visual Analogue Scale (VAS) post operatively | Patients will complete pain VAS in recovery and each hospital day post operatively until discharge. The majority of papers comparing acute postoperative pain use a VAS. It is a simple measure that is easy to use by patients and currently in use by nurses at our site both in the post anesthetic recovery room and on the units. The VAS measures patient perceived pain intensity on a 10cm single axis scale ranging from no pain (0 cm) to worst pain ever experienced (10cm). | Daily until discharge (3 days on average) | 
| Time in recovery (hours) | Time in recovery (hours): will be collected from the recovery room chart. | Until discharge from recovery (on average 2 hours) | 
| Morphine use in recovery | Morphine use in recovery (mg of morphine): will be collected from the recovery room chart. | Until discharge from recovery (on average 2 hours) | 
| Adverse events as a result of morphine overdosage | Any emergencies as a result of morphine overdosage: will be collected from the recovery room chart. | Until discharge from recovery (on average 2 hours) | 
| Change in pain score | Change in pain score: will be calculated as: baseline SF-MPQ2 minus six week SF-MPQ2 for total and each subscore of SF-MPQ2. | baseline - 6 weeks post-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hysterectomy, Pain Prevention, Wound Infiltration