NCT01511627

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Saskatchewan · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-01-18
• Last updated: 2016-11-15

Locations

1 site across 1 country: Canada