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

This study has been terminated.
(Funding withdrawn)
Sponsor:
Information provided by (Responsible Party):
Wynne Innez Leung, University of Calgary
ClinicalTrials.gov Identifier:
NCT01627353
First received: June 19, 2012
Last updated: June 18, 2014
Last verified: June 2014

June 19, 2012
June 18, 2014
January 2012
March 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01627353 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Post Hysterectomy Pain Prevention: Pre-op Wound Infiltration With Anesthetic Protocol Versus Standard of Care
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)

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Hysterectomy
  • Procedure: Standard of care
    Current Standard of Care at Rockyview General Hospital for Post Hysterectomy Pain Prevention(no wound infiltration and routine anesthetic protocol).
  • 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:
    • Magnesium Sulphate
    • Dexamethasone
    • Lidocaine
  • 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).
    Intervention: Procedure: Standard of care
  • 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.
    Intervention: Procedure: Pre-emptive wound infiltration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01627353
E-23700
No
Wynne Innez Leung, University of Calgary
University of Calgary
Not Provided
Principal Investigator: Wynne Leung University of Calgary
University of Calgary
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP