HysterectomyNCT01511627
Randomized Controlled Trial Comparing Postoperative Pain Following TAH With GA vs. Combined GA + SAB
A study testing General Anesthesia + Spinal anesthesia combined in people with Hysterectomy, run by University of Saskatchewan at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- General Anesthesia + Spinal anesthesia combined
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists' (ASA) I and II patients undergoing elective Total Abdominal Hysterectomy at the Saskatoon City Hospital
- Lower transverse abdominal incision
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing Postoperative Pain Following Total Abdominal Hysterectomy With General Anesthetic vs. Combined General and Spinal Anesthetic
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
- Being tested
- General Anesthesia + Spinal anesthesia combined, General Anesthesia (control group)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Anesthesia + Spinal anesthesia combinedDrug
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)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).
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia | Active comparator | Not described Receives: Drug: General Anesthesia (control group) |
| General Anesthesia + Spinal Anesthesia | Experimental | Not described Receives: Drug: General Anesthesia + Spinal anesthesia combined |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Post-operative day 2
Secondary outcomes (18)
Pain score on the VAS
Measured: In the PACU: within the first 5 minutes
Pain score on the VAS
Measured: In the PACU: after 30 minutes
Pain score on the VAS
Measured: In the PACU: after 60 minutes.
Pain score on the VAS
Measured: Upon arrival on the post-operative ward
Pain score on the VAS
Measured: On the post-operative ward: after 1 hour
Pain score on the VAS
Measured: On the post-operative ward: after 4 hours
Pain score on the VAS
Measured: On post-operative day 1 at 02:00
Pain score on the VAS
Measured: On post-operative days 1 at 06:00
Pain score on the VAS
Measured: On post-operative days 1 at 10:00
Pain score on the VAS
Measured: On post-operative days 1 at 14:00
Pain score on the VAS
Measured: On post-operative days 1 at 18:00
Pain score on the VAS
Measured: On post-operative days 1 at 22:00
Pain score on the VAS
Measured: On post-operative day 2 at 02:00
Pain score on the VAS
Measured: On post-operative day 2 at 06:00
Pain score on the VAS
Measured: On post-operative day 2 at 10:00
Pain score on the VAS
Measured: On post-operative day 2 at 14:00
Pain score on the VAS
Measured: On post-operative day 2 at 18:00
Pain score on the VAS
Measured: On post-operative day 2 at 22:00
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: Research question was answered by Acta Anaesthesiol Scand 2012; 56: 102-109.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacelyn Larson, University of Saskatchewan
- Investigators
- Jacelyn Larson, MD, FRCPC, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511627
- Sponsor's protocol ID
- RCT GA + SAB for TAH
- Status last verified
- Nov 2016
- First submitted
- 9 Jan 2012
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Postoperative Pain Following Total Abdominal Hysterectomy With General Anesthetic vs. Combined General and Spinal Anesthetic
- ClinicalTrials.gov ID
- NCT01511627
- Acronym / sponsor ID
- RCT GA + SAB for TAH
- Conditions
- Hysterectomy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Research question was answered by Acta Anaesthesiol Scand 2012; 56: 102-109.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 18 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | Active comparator | Drug: General Anesthesia (control group) |
| General Anesthesia + Spinal Anesthesia | Experimental | Drug: General Anesthesia + Spinal anesthesia combined |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists' (ASA) I and II patients undergoing elective Total Abdominal Hysterectomy at the Saskatoon City Hospital
- Lower transverse abdominal incision
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General Anesthesia + Spinal anesthesia combinedAll 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). | Drug | General Anesthesia + Spinal Anesthesia |
| 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). | Drug | General Anesthesia |
Primary outcome
Morphine consumption
Time frame: 1 day
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
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
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.
18 secondary outcomes
Pain score on the VAS
Time frame: In the PACU: within the first 5 minutes
Pain score on the VAS
Time frame: In the PACU: after 30 minutes
Pain score on the VAS
Time frame: In the PACU: after 60 minutes.
Pain score on the VAS
Time frame: Upon arrival on the post-operative ward
Pain score on the VAS
Time frame: On the post-operative ward: after 1 hour
Pain score on the VAS
Time frame: On the post-operative ward: after 4 hours
Pain score on the VAS
Time frame: On post-operative day 1 at 02:00
Pain score on the VAS
Time frame: On post-operative days 1 at 06:00
Pain score on the VAS
Time frame: On post-operative days 1 at 10:00
Pain score on the VAS
Time frame: On post-operative days 1 at 14:00
Pain score on the VAS
Time frame: On post-operative days 1 at 18:00
Pain score on the VAS
Time frame: On post-operative days 1 at 22:00
Pain score on the VAS
Time frame: On post-operative day 2 at 02:00
Pain score on the VAS
Time frame: On post-operative day 2 at 06:00
Pain score on the VAS
Time frame: On post-operative day 2 at 10:00
Pain score on the VAS
Time frame: On post-operative day 2 at 14:00
Pain score on the VAS
Time frame: On post-operative day 2 at 18:00
Pain score on the VAS
Time frame: On post-operative day 2 at 22:00
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacelyn Larson, MD, FRCPC principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General Anesthesia + Spinal anesthesia combined in people with Hysterectomy, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.