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

University of Calgary

Status and phase: Terminated; Phase 4

Conditions: Hysterectomy

Treatments: Procedure: Standard of care; Procedure: Pre-emptive wound infiltration

Study type: Interventional

Funder types: Other

Identifiers

NCT01627353

E-23700

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

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

Treatment:

Procedure: Standard of care

Pre-emptive wound infiltration

Experimental group

Description:

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.

Treatment:

Procedure: Pre-emptive wound infiltration