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

Hysterectomy Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Postoperative Pain Following Total Abdominal Hysterectomy With General Anesthetic vs. Combined General and Spinal Anesthetic

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01511627
• Other study ID #: RCT GA + SAB for TAH
• Status: Withdrawn
• Phase: N/A
• First received: January 9, 2012
• Last updated: November 10, 2016
• Start date: January 2012
• Est. completion date: July 2012

Study information

• Verified date: November 2016
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hysterectomy
• Pain, Postoperative

Intervention

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).
• 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).

Locations

Country	Name	City	State
Canada	Saskatoon City Hospital	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Pain score on the VAS		In the PACU: within the first 5 minutes	No
Secondary	Pain score on the VAS		In the PACU: after 30 minutes	No
Secondary	Pain score on the VAS		In the PACU: after 60 minutes.	No
Secondary	Pain score on the VAS		Upon arrival on the post-operative ward	No
Secondary	Pain score on the VAS		On the post-operative ward: after 1 hour	No
Secondary	Pain score on the VAS		On the post-operative ward: after 4 hours	No
Secondary	Pain score on the VAS		On post-operative day 1 at 02:00	No
Secondary	Pain score on the VAS		On post-operative days 1 at 06:00	No
Secondary	Pain score on the VAS		On post-operative days 1 at 10:00	No
Secondary	Pain score on the VAS		On post-operative days 1 at 14:00	No
Secondary	Pain score on the VAS		On post-operative days 1 at 18:00	No
Secondary	Pain score on the VAS		On post-operative days 1 at 22:00	No
Secondary	Pain score on the VAS		On post-operative day 2 at 02:00	No
Secondary	Pain score on the VAS		On post-operative day 2 at 06:00	No
Secondary	Pain score on the VAS		On post-operative day 2 at 10:00	No
Secondary	Pain score on the VAS		On post-operative day 2 at 14:00	No
Secondary	Pain score on the VAS		On post-operative day 2 at 18:00	No
Secondary	Pain score on the VAS		On post-operative day 2 at 22:00	No