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

Hysterectomy Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01627353
• Other study ID #: E-23700
• 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

• Hysterectomy

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