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(Funding withdrawn)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
  Purpose

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.


Condition Intervention Phase
Hysterectomy
Procedure: Standard of care
Procedure: Pre-emptive wound infiltration
Phase 4

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

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 16
Study Start Date: January 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Magnesium Sulphate
  • Dexamethasone
  • Lidocaine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627353

Locations
Canada, Alberta
Rockyview General Hospital
Calgary, Alberta, Canada, T2V 1P9
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Wynne Leung University of Calgary
  More Information

No publications provided

Responsible Party: Wynne Innez Leung, Clinical Assistant Professor, General, University of Calgary
ClinicalTrials.gov Identifier: NCT01627353     History of Changes
Other Study ID Numbers: E-23700
Study First Received: June 19, 2012
Last Updated: June 18, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of Calgary:
Hysterectomy
Pain Prevention
Wound Infiltration

Additional relevant MeSH terms:
Anesthetics
Lidocaine
Magnesium Sulfate
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Sensory System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Analgesics

ClinicalTrials.gov processed this record on July 22, 2014