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

NCT ID: NCT01511627

Last Updated: 2016-11-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

General Anesthesia

Group Type: ACTIVE_COMPARATOR

General Anesthesia (control group)

Intervention Type: 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 + Spinal Anesthesia

Group Type: EXPERIMENTAL

General Anesthesia + Spinal anesthesia combined

Intervention Type: 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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Saskatchewan

OTHER

Sponsor Role: lead

Responsible Party

Jacelyn Larson

Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jacelyn Larson, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

Saskatoon City Hospital

Saskatoon, Saskatchewan, Canada

Countries

Canada

Other Identifiers

RCT GA + SAB for TAH

Identifier Type: -

Identifier Source: org_study_id