Randomized Controlled Trial Comparing Postoperative Pain Following TAH With GA vs. Combined GA + SAB

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial Comparing Postoperative Pain Following Total Abdominal Hysterectomy With General Anesthetic vs. Combined General and Spinal Anesthetic

Conditions
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Hysterectomy

Intervention / Treatment
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* Drug: General Anesthesia + Spinal anesthesia combined
* Drug: General Anesthesia (control group)


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: General Anesthesia<br> | Drug: General Anesthesia (control group)<br>* 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).<br>|
| Experimental: General Anesthesia + Spinal Anesthesia<br> | Drug: General Anesthesia + Spinal anesthesia combined<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 day | 
| 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. | Post-operative day 1 | 
| 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. | Post-operative day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score on the VAS |  | In the PACU: within the first 5 minutes | 
| Pain score on the VAS |  | In the PACU: after 30 minutes | 
| Pain score on the VAS |  | In the PACU: after 60 minutes. | 
| Pain score on the VAS |  | Upon arrival on the post-operative ward | 
| Pain score on the VAS |  | On the post-operative ward: after 1 hour | 
| Pain score on the VAS |  | On the post-operative ward: after 4 hours | 
| Pain score on the VAS |  | On post-operative day 1 at 02:00 | 
| Pain score on the VAS |  | On post-operative days 1 at 06:00 | 
| Pain score on the VAS |  | On post-operative days 1 at 10:00 | 
| Pain score on the VAS |  | On post-operative days 1 at 14:00 | 
| Pain score on the VAS |  | On post-operative days 1 at 18:00 | 
| Pain score on the VAS |  | On post-operative days 1 at 22:00 | 
| Pain score on the VAS |  | On post-operative day 2 at 02:00 | 
| Pain score on the VAS |  | On post-operative day 2 at 06:00 | 
| Pain score on the VAS |  | On post-operative day 2 at 10:00 | 
| Pain score on the VAS |  | On post-operative day 2 at 14:00 | 
| Pain score on the VAS |  | On post-operative day 2 at 18:00 | 
| Pain score on the VAS |  | On post-operative day 2 at 22:00 |