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)
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Hysterectomy
- Sponsor
- University of Calgary
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Post Operative Morphine
- Status
- Terminated
- Last Updated
- 11 years ago
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.
Investigators
Wynne Innez Leung
Clinical Assistant Professor, General
University of Calgary
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
Outcomes
Primary Outcomes
Post Operative Morphine
Time Frame: For the entire post-operative hospital admission (3 days on average)
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.
Secondary Outcomes
- Time in recovery (hours)(Until discharge from recovery (on average 2 hours))
- Morphine use in recovery(Until discharge from recovery (on average 2 hours))
- Adverse events as a result of morphine overdosage(Until discharge from recovery (on average 2 hours))
- Change in pain score(baseline - 6 weeks post-operative)
- Pain measurement using Visual Analogue Scale (VAS) post operatively(Daily until discharge (3 days on average))