HysterectomyPhase 4NCT01627353
Post Hysterectomy Pain Prevention: Pre-op Wound Infiltration With Anesthetic Protocol Versus Standard of Care
A Phase 4 study testing Pre-emptive wound infiltration in people with Hysterectomy, run by University of Calgary at 1 site in Canada.
Trial summary
The study is a blinded randomized clinical trial, comparing policies of high volume preemptive wound infiltration with a specific anesthetic cocktail versus standard of care (no wound infiltration and routine anesthesia) for post operative pain management after hysterectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- Pre-emptive wound infiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Mar 2014
- Phase
- Phase 4
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women may be included if they require total abdominal hysterectomies (+/- BSO) at Rockyview hospital.
Who cannot join
- have endometrial cancer,
- require a vertical midline incision,
- have any additional surgery planned
- have a contraindication to morphine, Magnesium Sulfate, Dexmethasone, Lidocaine or Marcaine
- have difficulty communicating in English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Hysterectomy Pain Prevention: Randomized Clinical Trial of High Volume Preoperative Wound Infiltration and Pain Specific Anesthetic Protocol Versus Standard of Care (no Wound Infiltration and Routine Anesthetic Protocol)
The study is a blinded randomized clinical trial, comparing policies of high volume preemptive wound infiltration with a specific anesthetic cocktail versus standard of care (no wound infiltration and routine anesthesia) for post operative pain management after hysterectomy. Morphine use and pain will be measured during index admission, and pain will also be measured six weeks postoperatively. The study will be conducted at a single site, Rockyview General Hospital.
- Conditions
- Hysterectomy
- Being tested
- Standard of care, Pre-emptive wound infiltration
- Keywords
- Hysterectomy, Pain Prevention, Wound Infiltration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careProcedure or surgery
Current Standard of Care at Rockyview General Hospital for Post Hysterectomy Pain Prevention(no wound infiltration and routine anesthetic protocol).
Pre-emptive wound infiltrationProcedure or surgery
Also called Magnesium Sulphate, Dexamethasone, Lidocaine
The Wound Infiltration Group will receive 100 mL 0.125% marcaine plain distributed as follows: 50 mL subcutaneously prior to skin incision along entire length of planned incision line, 50 mL subfascially prior to fascial incision, with 10 mL infiltrated directly into the rectus muscles bilaterally.
The Anesthetic will be given as determined appropriate to the patient by the staff anesthetist with the addition of the following: 2 grams of Magnesium Sulphate, 10 mg of Dexamethasone, and 3 mg/kg of Lidocaine, half of which is given on induction and half of which is infused throughout the remainder of the case.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Current Standard of Care at Rockyview General Hospital for Post Hysterectomy Pain Prevention(no wound infiltration and routine anesthetic protocol). Receives: Procedure: Standard of care |
| Pre-emptive wound infiltration | Experimental | The Wound Infiltration Group will receive 100 mL 0.25% marcaine plain distributed as follows: 50 mL subcutaneously prior to skin incision along entire length of planned incision line, 50 mL subfascially prior to fascial incision, with 10 mL infiltrated directly into the rectus muscles bilaterally. Receives: Procedure: Pre-emptive wound infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative Morphine
The amount of post operative morphine (PCA IV) will be recorded from the PCA device each day by the Acute Pain Service Nurses. The total dose (mg morphine) will be recorded for each 24 hour period, and summed for the complete postoperative period of admission.
Measured: For the entire post-operative hospital admission (3 days on average)
Secondary outcomes (5)
Pain measurement using Visual Analogue Scale (VAS) post operatively
Patients will complete pain VAS in recovery and each hospital day post operatively until discharge.
The majority of papers comparing acute postoperative pain use a VAS. It is a simple measure that is easy to use by patients and currently in use by nurses at our site both in the post anesthetic recovery room and on the units. The VAS measures patient perceived pain intensity on a 10cm single axis scale ranging from no pain (0 cm) to worst pain ever experienced (10cm).
Measured: Daily until discharge (3 days on average)
Time in recovery (hours)
Time in recovery (hours): will be collected from the recovery room chart.
Measured: Until discharge from recovery (on average 2 hours)
Morphine use in recovery
Morphine use in recovery (mg of morphine): will be collected from the recovery room chart.
Measured: Until discharge from recovery (on average 2 hours)
Adverse events as a result of morphine overdosage
Any emergencies as a result of morphine overdosage: will be collected from the recovery room chart.
Measured: Until discharge from recovery (on average 2 hours)
Change in pain score
Change in pain score: will be calculated as: baseline SF-MPQ2 minus six week SF-MPQ2 for total and each subscore of SF-MPQ2.
Measured: baseline - 6 weeks post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Funding withdrawn
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.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wynne Innez Leung, University of Calgary
- Investigators
- Wynne Leung, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627353
- Sponsor's protocol ID
- E-23700
- Status last verified
- Jun 2014
- First submitted
- 19 Jun 2012
- Last updated
- 20 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Hysterectomy Pain Prevention: Randomized Clinical Trial of High Volume Preoperative Wound Infiltration and Pain Specific Anesthetic Protocol Versus Standard of Care (no Wound Infiltration and Routine Anesthetic Protocol)
- ClinicalTrials.gov ID
- NCT01627353
- Acronym / sponsor ID
- E-23700
- Conditions
- Hysterectomy
- Keywords
- Hysterectomy, Pain Prevention, Wound Infiltration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding withdrawn
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 25 Jun 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 study is a blinded randomized clinical trial, comparing policies of high volume preemptive wound infiltration with a specific anesthetic cocktail versus standard of care (no wound infiltration and routine anesthesia) for post operative pain management after hysterectomy. Morphine use and pain will be measured during index admission, and pain will also be measured six weeks postoperatively. The study will be conducted at a single site, Rockyview General Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Procedure: Standard of careCurrent Standard of Care at Rockyview General Hospital for Post Hysterectomy Pain Prevention(no wound infiltration and routine anesthetic protocol). |
| Pre-emptive wound infiltration | Experimental | Procedure: Pre-emptive wound infiltrationThe Wound Infiltration Group will receive 100 mL 0.25% marcaine plain distributed as follows: 50 mL subcutaneously prior to skin incision along entire length of planned incision line, 50 mL subfascially prior to fascial incision, with 10 mL infiltrated directly into the rectus muscles bilaterally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women may be included if they require total abdominal hysterectomies (+/- BSO) at Rockyview hospital.
Key exclusion criteria (5 listed)
- have endometrial cancer,
- require a vertical midline incision,
- have any additional surgery planned
- have a contraindication to morphine, Magnesium Sulfate, Dexmethasone, Lidocaine or Marcaine
- have difficulty communicating in English
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 |
|---|---|---|
| Standard of careCurrent Standard of Care at Rockyview General Hospital for Post Hysterectomy Pain Prevention(no wound infiltration and routine anesthetic protocol). | Procedure or surgery | Standard of Care |
| Pre-emptive wound infiltrationAlso: Magnesium Sulphate, Dexamethasone, LidocaineThe Wound Infiltration Group will receive 100 mL 0.125% marcaine plain distributed as follows: 50 mL subcutaneously prior to skin incision along entire length of planned incision line, 50 mL subfascially prior to fascial incision, with 10 mL infiltrated directly into the rectus muscles bilaterally. The Anesthetic will be given as determined appropriate to the patient by the staff anesthetist with the addition of the following: 2 grams of Magnesium Sulphate, 10 mg of Dexamethasone, and 3 mg/kg of Lidocaine, half of which is given on induction and half of which is infused throughout the remainder of the case. | Procedure or surgery | Pre-emptive wound infiltration |
Primary outcome
Post Operative Morphine
Time frame: For the entire post-operative hospital admission (3 days on average)
The amount of post operative morphine (PCA IV) will be recorded from the PCA device each day by the Acute Pain Service Nurses. The total dose (mg morphine) will be recorded for each 24 hour period, and summed for the complete postoperative period of admission.
5 secondary outcomes
Pain measurement using Visual Analogue Scale (VAS) post operatively
Time frame: Daily until discharge (3 days on average)
Time in recovery (hours)
Time frame: Until discharge from recovery (on average 2 hours)
Morphine use in recovery
Time frame: Until discharge from recovery (on average 2 hours)
Adverse events as a result of morphine overdosage
Time frame: Until discharge from recovery (on average 2 hours)
Change in pain score
Time frame: baseline - 6 weeks post-operative
Results and safety
The study was stopped early (reason given: Funding withdrawn). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2014.
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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.
Wynne Leung principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pre-emptive wound infiltration in people with Hysterectomy, run by University of Calgary 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 1 inclusion and 5 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: stopped early, as of the sponsor's last update on 20 Jun 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Funding withdrawn). Results are not available in the source record.
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?
Post Operative Morphine (time frame: For the entire post-operative hospital admission (3 days on average)). 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 20 Jun 2014.