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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01511627
Other study ID # RCT GA + SAB for TAH
Secondary ID
Status Withdrawn
Phase N/A
First received January 9, 2012
Last updated November 10, 2016
Start date January 2012
Est. completion date July 2012

Study information

Verified date November 2016
Source University of Saskatchewan
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
General Anesthesia + Spinal anesthesia combined
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).
General Anesthesia (control group)
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).

Locations

Country Name City State
Canada Saskatoon City Hospital Saskatoon Saskatchewan

Sponsors (1)

Lead Sponsor Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Primary 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 No
Secondary Pain score on the VAS In the PACU: within the first 5 minutes No
Secondary Pain score on the VAS In the PACU: after 30 minutes No
Secondary Pain score on the VAS In the PACU: after 60 minutes. No
Secondary Pain score on the VAS Upon arrival on the post-operative ward No
Secondary Pain score on the VAS On the post-operative ward: after 1 hour No
Secondary Pain score on the VAS On the post-operative ward: after 4 hours No
Secondary Pain score on the VAS On post-operative day 1 at 02:00 No
Secondary Pain score on the VAS On post-operative days 1 at 06:00 No
Secondary Pain score on the VAS On post-operative days 1 at 10:00 No
Secondary Pain score on the VAS On post-operative days 1 at 14:00 No
Secondary Pain score on the VAS On post-operative days 1 at 18:00 No
Secondary Pain score on the VAS On post-operative days 1 at 22:00 No
Secondary Pain score on the VAS On post-operative day 2 at 02:00 No
Secondary Pain score on the VAS On post-operative day 2 at 06:00 No
Secondary Pain score on the VAS On post-operative day 2 at 10:00 No
Secondary Pain score on the VAS On post-operative day 2 at 14:00 No
Secondary Pain score on the VAS On post-operative day 2 at 18:00 No
Secondary Pain score on the VAS On post-operative day 2 at 22:00 No
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