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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01627353
Other study ID # E-23700
Secondary ID
Status Terminated
Phase Phase 4
First received June 19, 2012
Last updated June 18, 2014
Start date January 2012
Est. completion date March 2014

Study information

Verified date June 2014
Source University of Calgary
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 16
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Standard of care
Current Standard of Care at Rockyview General Hospital for Post Hysterectomy Pain Prevention(no wound infiltration and routine anesthetic protocol).
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.

Locations

Country Name City State
Canada Rockyview General Hospital Calgary Alberta

Sponsors (1)

Lead Sponsor Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
Secondary 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) No
Secondary Time in recovery (hours) Time in recovery (hours): will be collected from the recovery room chart. Until discharge from recovery (on average 2 hours) No
Secondary 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) No
Secondary 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) Yes
Secondary 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 No
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