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

NCT01511627 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-11-15

No results posted yet for this study

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.

Conditions

  • Hysterectomy

Interventions

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).

DRUG

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).

Sponsors & Collaborators

  • University of Saskatchewan

    lead OTHER

Principal Investigators

  • Jacelyn Larson, MD, FRCPC · University of Saskatchewan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01511627 on ClinicalTrials.gov