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

NCT01627353 | Terminated Phase 4

• 1 other identifier: E-23700
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hysterectomy; Pain Prevention; Wound Infiltration

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (5)

• Pain measurement using Visual Analogue Scale (VAS) post operatively

  Daily until discharge (3 days on average)

• Time in recovery (hours)

  Until discharge from recovery (on average 2 hours)

• Morphine use in recovery

  Until discharge from recovery (on average 2 hours)

• Adverse events as a result of morphine overdosage

  Until discharge from recovery (on average 2 hours)

• Change in pain score

  baseline - 6 weeks post-operative

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

Procedure: Standard of care

Pre-emptive wound infiltration

EXPERIMENTAL

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

Interventions

Standard of care PROCEDURE

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

Standard of Care

Pre-emptive wound infiltration PROCEDURE

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.

Also known as: Magnesium Sulphate, Dexamethasone, Lidocaine

Pre-emptive wound infiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women may be included if they require total abdominal hysterectomies (+/- BSO) at Rockyview hospital.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Rockyview General Hospital

Calgary, Alberta, T2V 1P9, Canada

Location

MeSH Terms

Interventions

Standard of Care; Magnesium Sulfate; Dexamethasone; Lidocaine

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Wynne Leung

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, General

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 25, 2012
• Study Start: January 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: June 20, 2014

Record last verified: 2014-06

Locations

CA (1)