Randomized Controlled Trial Comparing Postoperative Pain Following TAH With GA vs. Combined GA + SAB
Primary Purpose
Hysterectomy
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
General Anesthesia + Spinal anesthesia combined
General Anesthesia (control group)
Sponsored by
About this trial
This is an interventional treatment trial for 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).
Sites / Locations
- Saskatoon City Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
General Anesthesia
General Anesthesia + Spinal Anesthesia
Arm Description
Outcomes
Primary Outcome Measures
Morphine consumption
The primary outcome will be total opioid use per day, as recorded by the PCA pump and transcribed by the nursing staff in the PACU and on the post-operative ward.
Total Morphine consumption
The primary outcome will be total opioid use per day, as recorded by the PCA pump and transcribed by the nursing staff in the PACU and on the post-operative ward.
Total Morphine consumption
The primary outcome will be total opioid use per day, as recorded by the PCA pump and transcribed by the nursing staff in the PACU and on the post-operative ward.
Secondary Outcome Measures
Pain score on the VAS
Pain score on the VAS
Pain score on the VAS
Pain score on the VAS
Pain score on the VAS
Pain score on the VAS
Pain score on the VAS
Pain score on the VAS
Pain score on the VAS
Pain score on the VAS
Pain score on the VAS
Pain score on the VAS
Pain score on the VAS
Pain score on the VAS
Pain score on the VAS
Pain score on the VAS
Pain score on the VAS
Pain score on the VAS
Full Information
NCT ID
NCT01511627
First Posted
January 9, 2012
Last Updated
November 10, 2016
Sponsor
University of Saskatchewan
1. Study Identification
Unique Protocol Identification Number
NCT01511627
Brief Title
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
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Research question was answered by Acta Anaesthesiol Scand 2012; 56: 102-109.
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hysterectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
General Anesthesia
Arm Type
Active Comparator
Arm Title
General Anesthesia + Spinal Anesthesia
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
General Anesthesia + Spinal anesthesia combined
Intervention Description
All patients will receive a preoperative multimodal analgesic regime:
Tylenol® 975mg per os
Naproxen® 500 mg per os
Patients will receive a spinal anesthetic with:
Bupivacaine 0.5% 10 mg
Fentanyl 10ug
Epidural Morphine 150ug
After the spinal, a general anesthetic will be induced using:
Midazolam 1 - 2 mg intravenously
Fentanyl 1 - 2 ug/kg intravenously
Propofol 1-3 mg/kg intravenously
Rocuronium 0.3 - 0.9mg/kg intravenously
followed by endotracheal intubation. Maintenance of anesthesia with sevoflurane, oxygen and air.
Intraoperative Morphine 0 - 0.3mg/kg or Fentanyl 0 - 7.5ug/kg to maintain MAP and heart rate within 20% of baseline.
Phenylephrine and Ephedrine can be used to support blood pressure and heart rate within 20% of baseline.
Dexamethasone 4mg and Ondansetron 4mg intravenously
Neostigmine 3mg and Glycopyrrolate 0.6mg intravenously Patients will receive a Morphine PCA to be initiated in the Post Anesthetic Care Unit (PACU).
Intervention Type
Drug
Intervention Name(s)
General Anesthesia (control group)
Intervention Description
All patients will receive a preoperative multimodal analgesic regime:
Tylenol® 975mg per os
Naproxen® 500 mg per os
Group I (General anesthetic) patients will receive a general anesthetic :
Midazolam 1 - 2 mg intravenously
Fentanyl 1 - 2 ug/kg intravenously
Propofol 1-3 mg/kg intravenously
Rocuronium 0.3 - 0.9mg/kg intravenously
followed by endotracheal intubation. Maintenance of anesthesia with sevoflurane, oxygen and air.
Intraoperative Morphine 0 - 0.3mg/kg or Fentanyl 0 - 7.5ug/kg. to maintain MAP and heart rate within 20% of baseline.
Phenylephrine and Ephedrine can be used to support blood pressure and heart rate within 20% of baseline.
Dexamethasone 4mg and Ondansetron 4mg intravenously
Neostigmine 3mg and Glycopyrrolate 0.6mg intravenously
Patients will receive a Morphine PCA as per protocol that will be initiated in the Post Anesthetic Care Unit (PACU).
Primary Outcome Measure Information:
Title
Morphine consumption
Description
The primary outcome will be total opioid use per day, as recorded by the PCA pump and transcribed by the nursing staff in the PACU and on the post-operative ward.
Time Frame
1 day
Title
Total Morphine consumption
Description
The primary outcome will be total opioid use per day, as recorded by the PCA pump and transcribed by the nursing staff in the PACU and on the post-operative ward.
Time Frame
Post-operative day 1
Title
Total Morphine consumption
Description
The primary outcome will be total opioid use per day, as recorded by the PCA pump and transcribed by the nursing staff in the PACU and on the post-operative ward.
Time Frame
Post-operative day 2
Secondary Outcome Measure Information:
Title
Pain score on the VAS
Time Frame
In the PACU: within the first 5 minutes
Title
Pain score on the VAS
Time Frame
In the PACU: after 30 minutes
Title
Pain score on the VAS
Time Frame
In the PACU: after 60 minutes.
Title
Pain score on the VAS
Time Frame
Upon arrival on the post-operative ward
Title
Pain score on the VAS
Time Frame
On the post-operative ward: after 1 hour
Title
Pain score on the VAS
Time Frame
On the post-operative ward: after 4 hours
Title
Pain score on the VAS
Time Frame
On post-operative day 1 at 02:00
Title
Pain score on the VAS
Time Frame
On post-operative days 1 at 06:00
Title
Pain score on the VAS
Time Frame
On post-operative days 1 at 10:00
Title
Pain score on the VAS
Time Frame
On post-operative days 1 at 14:00
Title
Pain score on the VAS
Time Frame
On post-operative days 1 at 18:00
Title
Pain score on the VAS
Time Frame
On post-operative days 1 at 22:00
Title
Pain score on the VAS
Time Frame
On post-operative day 2 at 02:00
Title
Pain score on the VAS
Time Frame
On post-operative day 2 at 06:00
Title
Pain score on the VAS
Time Frame
On post-operative day 2 at 10:00
Title
Pain score on the VAS
Time Frame
On post-operative day 2 at 14:00
Title
Pain score on the VAS
Time Frame
On post-operative day 2 at 18:00
Title
Pain score on the VAS
Time Frame
On post-operative day 2 at 22:00
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacelyn Larson, MD, FRCPC
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saskatoon City Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K0M7
Country
Canada
12. IPD Sharing Statement
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Randomized Controlled Trial Comparing Postoperative Pain Following TAH With GA vs. Combined GA + SAB
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