Post Hysterectomy Pain Prevention: Pre-op Wound Infiltration With Anesthetic Protocol Versus Standard of Care
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hysterectomy |
Procedure: Standard of care Procedure: Pre-emptive wound infiltration |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| 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) |
- Post Operative Morphine [ Time Frame: For the entire post-operative hospital admission (3 days on average) ] [ Designated as safety issue: No ]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.
- Pain measurement using Visual Analogue Scale (VAS) post operatively [ Time Frame: Daily until discharge (3 days on average) ] [ Designated as safety issue: No ]
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).
- Time in recovery (hours) [ Time Frame: Until discharge from recovery (on average 2 hours) ] [ Designated as safety issue: No ]Time in recovery (hours): will be collected from the recovery room chart.
- Morphine use in recovery [ Time Frame: Until discharge from recovery (on average 2 hours) ] [ Designated as safety issue: No ]Morphine use in recovery (mg of morphine): will be collected from the recovery room chart.
- Adverse events as a result of morphine overdosage [ Time Frame: Until discharge from recovery (on average 2 hours) ] [ Designated as safety issue: Yes ]Any emergencies as a result of morphine overdosage: will be collected from the recovery room chart.
- Change in pain score [ Time Frame: baseline - 6 weeks post-operative ] [ Designated as safety issue: No ]Change in pain score: will be calculated as: baseline SF-MPQ2 minus six week SF-MPQ2 for total and each subscore of SF-MPQ2.
| Estimated Enrollment: | 86 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Standard of Care
Current Standard of Care at Rockyview General Hospital for Post Hysterectomy Pain Prevention(no wound infiltration and routine anesthetic protocol).
|
Procedure: Standard of care
Current Standard of Care at Rockyview General Hospital for Post Hysterectomy Pain Prevention(no wound infiltration and routine anesthetic protocol).
|
|
Experimental: Pre-emptive wound infiltration
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
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. Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Canada, Alberta | |
| Rockyview General Hospital | Recruiting |
| Calgary, Alberta, Canada, T2V 1P9 | |
| Contact: Wynne Leung wynne.leung@albertahealthservices.ca | |
| Principal Investigator: Wynne Leung, MD | |
| Principal Investigator: | Wynne Leung | University of Calgary |
More Information
No publications provided
| Responsible Party: | Wynne Innez Leung, Clinical Assistant Professor, General, University of Calgary |
| ClinicalTrials.gov Identifier: | NCT01627353 History of Changes |
| Other Study ID Numbers: | E-23700 |
| Study First Received: | June 19, 2012 |
| Last Updated: | June 22, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of Calgary:
|
Hysterectomy Pain Prevention Wound Infiltration |
Additional relevant MeSH terms:
|
Anesthetics Lidocaine Magnesium Sulfate Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anti-Inflammatory Agents Antiemetics Autonomic Agents |
Peripheral Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anesthetics, Local Sensory System Agents Anti-Arrhythmia Agents Cardiovascular Agents Analgesics |
ClinicalTrials.gov processed this record on May 21, 2013