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

June 18, 2014 updated by: Wynne Innez Leung, University of Calgary

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2V 1P9
        • Rockyview General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Lidocaine
  • Dexamethasone
  • Magnesium Sulphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
For the entire post-operative hospital admission (3 days on average)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain measurement using Visual Analogue Scale (VAS) post operatively
Time Frame: Daily until discharge (3 days on average)

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)
Time in recovery (hours)
Time Frame: Until discharge from recovery (on average 2 hours)
Time in recovery (hours): will be collected from the recovery room chart.
Until discharge from recovery (on average 2 hours)
Morphine use in recovery
Time Frame: Until discharge from recovery (on average 2 hours)
Morphine use in recovery (mg of morphine): will be collected from the recovery room chart.
Until discharge from recovery (on average 2 hours)
Adverse events as a result of morphine overdosage
Time Frame: Until discharge from recovery (on average 2 hours)
Any emergencies as a result of morphine overdosage: will be collected from the recovery room chart.
Until discharge from recovery (on average 2 hours)
Change in pain score
Time Frame: baseline - 6 weeks post-operative
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Principal Investigator: Wynne Leung, University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

June 19, 2012

First Submitted That Met QC Criteria

June 22, 2012

First Posted (Estimate)

June 25, 2012

Study Record Updates

Last Update Posted (Estimate)

June 20, 2014

Last Update Submitted That Met QC Criteria

June 18, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-23700

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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