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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Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01511627
Enrollment
0
Registered
2012-01-18
Start date
2012-01-31
Completion date
2012-07-31
Last updated
2016-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysterectomy

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.

Interventions

DRUGGeneral 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).

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

University of Saskatchewan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Morphine consumption1 dayThe 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 consumptionPost-operative day 1The 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

MeasureTime frame
Pain score on the VASIn the PACU: within the first 5 minutes

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026