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

NCT01511627 | Withdrawn

• 1 other identifier: RCT GA + SAB for TAH
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (18)

• 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

Study Arms (2)

General Anesthesia

ACTIVE COMPARATOR

Drug: General Anesthesia (control group)

General Anesthesia + Spinal Anesthesia

EXPERIMENTAL

Drug: General Anesthesia + Spinal anesthesia combined

Interventions

General Anesthesia + Spinal anesthesia combined DRUG

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 + Spinal Anesthesia

General Anesthesia (control group) DRUG

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).

General Anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists' (ASA) I and II patients undergoing elective Total Abdominal Hysterectomy at the Saskatoon City Hospital
• Lower transverse abdominal incision

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Saskatoon City Hospital

Saskatoon, Saskatchewan, S7K0M7, Canada

Location

MeSH Terms

Interventions

Anesthesia, General; Control Groups

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jacelyn Larson, MD, FRCPC

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 18, 2012
• Study Start: January 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 15, 2016

Record last verified: 2016-11

Locations

CA (1)