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

NCT01627353 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-06-20

No results posted yet for this study

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.

Conditions

  • Hysterectomy

Interventions

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.

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Wynne Leung · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01627353 on ClinicalTrials.gov