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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hysterectomy
• Intervention / Treatment: Drug: General Anesthesia (control group); Drug: General Anesthesia + Spinal anesthesia combined

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K0M7
      • Saskatoon City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: General Anesthesia	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).
Experimental: General Anesthesia + Spinal Anesthesia	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).

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Investigators: Principal Investigator: Jacelyn Larson, MD, FRCPC, University of Saskatchewan

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: January 9, 2012
• First Submitted That Met QC Criteria: January 17, 2012
• First Posted (Estimate): January 18, 2012

Study Record Updates

• Last Update Posted (Estimate): November 15, 2016
• Last Update Submitted That Met QC Criteria: November 10, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: RCT GA + SAB for TAH