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

This study has been withdrawn prior to enrollment.
(Research question was answered by a publication in Acta Anaesthesiol Scand 2012; 56: 102-109.)
Sponsor:
Information provided by (Responsible Party):
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01511627
First received: January 9, 2012
Last updated: July 19, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Hysterectomy
Drug: General Anesthesia + Spinal anesthesia combined
Drug: General Anesthesia (control group)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Postoperative Pain Following Total Abdominal Hysterectomy With General Anesthetic vs. Combined General and Spinal Anesthetic

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • Morphine consumption [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.

  • Total Morphine consumption [ Time Frame: Post-operative day 1 ] [ Designated as safety issue: No ]
    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.

  • Total Morphine consumption [ Time Frame: Post-operative day 2 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Pain score on the VAS [ Time Frame: In the PACU: within the first 5 minutes ] [ Designated as safety issue: No ]
  • Pain score on the VAS [ Time Frame: In the PACU: after 30 minutes ] [ Designated as safety issue: No ]
  • Pain score on the VAS [ Time Frame: In the PACU: after 60 minutes. ] [ Designated as safety issue: No ]
  • Pain score on the VAS [ Time Frame: Upon arrival on the post-operative ward ] [ Designated as safety issue: No ]
  • Pain score on the VAS [ Time Frame: On the post-operative ward: after 1 hour ] [ Designated as safety issue: No ]
  • Pain score on the VAS [ Time Frame: On the post-operative ward: after 4 hours ] [ Designated as safety issue: No ]
  • Pain score on the VAS [ Time Frame: On post-operative day 1 at 02:00 ] [ Designated as safety issue: No ]
  • Pain score on the VAS [ Time Frame: On post-operative days 1 at 06:00 ] [ Designated as safety issue: No ]
  • Pain score on the VAS [ Time Frame: On post-operative days 1 at 10:00 ] [ Designated as safety issue: No ]
  • Pain score on the VAS [ Time Frame: On post-operative days 1 at 14:00 ] [ Designated as safety issue: No ]
  • Pain score on the VAS [ Time Frame: On post-operative days 1 at 18:00 ] [ Designated as safety issue: No ]
  • Pain score on the VAS [ Time Frame: On post-operative days 1 at 22:00 ] [ Designated as safety issue: No ]
  • Pain score on the VAS [ Time Frame: On post-operative day 2 at 02:00 ] [ Designated as safety issue: No ]
  • Pain score on the VAS [ Time Frame: On post-operative day 2 at 06:00 ] [ Designated as safety issue: No ]
  • Pain score on the VAS [ Time Frame: On post-operative day 2 at 10:00 ] [ Designated as safety issue: No ]
  • Pain score on the VAS [ Time Frame: On post-operative day 2 at 14:00 ] [ Designated as safety issue: No ]
  • Pain score on the VAS [ Time Frame: On post-operative day 2 at 18:00 ] [ Designated as safety issue: No ]
  • Pain score on the VAS [ Time Frame: On post-operative day 2 at 22:00 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511627

Locations
Canada, Saskatchewan
Saskatoon City Hospital
Saskatoon, Saskatchewan, Canada, S7K0M7
Sponsors and Collaborators
University of Saskatchewan
Investigators
Principal Investigator: Jacelyn Larson, MD, FRCPC University of Saskatchewan
  More Information

No publications provided

Responsible Party: University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01511627     History of Changes
Other Study ID Numbers: RCT GA + SAB for TAH
Study First Received: January 9, 2012
Last Updated: July 19, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014