Clinical trial NCT01511627: Randomized Controlled Trial Comparing Postoperative Pain Following TAH With GA vs. Combined GA + SAB
Official title: A Randomized Controlled Trial Comparing Postoperative Pain Following Total Abdominal Hysterectomy With General Anesthetic vs. Combined General and Spinal Anesthetic
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hysterectomy
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2012-01-18
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that a spinal anesthetic administered prior to the induction of general anesthesia will result in reduced need for pain medication and reduced postoperative pain, as well as reduced hospital stay following a total abdominal hysterectomy.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists' (ASA) I and II patients undergoing elective Total Abdominal Hysterectomy at the Saskatoon City Hospital
* Lower transverse abdominal incision

Exclusion Criteria:

* BMI \> 40
* The TAH is treatment for cancer
* A history of regular opioid use
* Any medical condition that would make a spinal inadvisable,
* An allergy or medical condition that would make it inadvisable to receive the drugs used in this study (eg. Peptic ulcer disease), or
* If you will also be having a salpingo-oophorectomy).

Primary outcomes:
measure: Morphine consumption
timeFrame: 1 day
measure: Total Morphine consumption
timeFrame: Post-operative day 1
measure: Total Morphine consumption
timeFrame: Post-operative day 2
Secondary outcomes:
measure: Pain score on the VAS
timeFrame: In the PACU: within the first 5 minutes
measure: Pain score on the VAS
timeFrame: In the PACU: after 30 minutes
measure: Pain score on the VAS
timeFrame: In the PACU: after 60 minutes.
measure: Pain score on the VAS
timeFrame: Upon arrival on the post-operative ward
measure: Pain score on the VAS
timeFrame: On the post-operative ward: after 1 hour
measure: Pain score on the VAS
timeFrame: On the post-operative ward: after 4 hours
measure: Pain score on the VAS
timeFrame: On post-operative day 1 at 02:00
measure: Pain score on the VAS
timeFrame: On post-operative days 1 at 06:00
measure: Pain score on the VAS
timeFrame: On post-operative days 1 at 10:00
measure: Pain score on the VAS
timeFrame: On post-operative days 1 at 14:00
measure: Pain score on the VAS
timeFrame: On post-operative days 1 at 18:00
measure: Pain score on the VAS
timeFrame: On post-operative days 1 at 22:00
measure: Pain score on the VAS
timeFrame: On post-operative day 2 at 02:00
measure: Pain score on the VAS
timeFrame: On post-operative day 2 at 06:00
measure: Pain score on the VAS
timeFrame: On post-operative day 2 at 10:00
measure: Pain score on the VAS
timeFrame: On post-operative day 2 at 14:00
measure: Pain score on the VAS
timeFrame: On post-operative day 2 at 18:00
measure: Pain score on the VAS
timeFrame: On post-operative day 2 at 22:00
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Saskatoon City Hospital
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Jacelyn Larson, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: