HysterectomyNCT03500744
Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery
A study testing Erector spinae plane block in people with Hysterectomy and Cystectomy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Regional anesthesia, also know as a nerve block, is a key component of pain control after major abdominal surgery. Bilateral erector spinae plane block (ESPB) performed at low thoracic level has been shown to be an effective pain control method in case reports. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hysterectomy, Cystectomy, Regional Anesthesia
- What is being tested?
- Erector spinae plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2019to 1 Aug 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult surgical patients who are American Society of Anesthesiologists (ASA) class I to III, undergoing cystectomy, or total abdominal hysterectomy, salpingo-oophrectomy with or without omentectomy via midline laparotomy.
Who cannot join
- BMI > 40
- Non-English speaking
- Patient refusal or inability to consent
- Cognitive or psychiatric history that would make it difficult to assess pain score
- Pre-existing chronic pain condition
- Preoperative opioid use greater than the equivalent of oral morphine 30 mg daily
Show all 11Show fewer
- Infection over site of block placement
- Allergy or contraindication to any study medication
- Coagulopathy or thrombocytopenia
- Postoperative ICU admission
- Presence of significant cardiac, respiratory, hepatic, renal or neurologic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Regional anesthesia, also know as a nerve block, is a key component of pain control after major abdominal surgery. Bilateral erector spinae plane block (ESPB) performed at low thoracic level has been shown to be an effective pain control method in case reports. This pilot study aims to further characterize the pain-control characteristics and to provide baseline data for future trials.
- Conditions
- Hysterectomy, Cystectomy, Regional Anesthesia
- Being tested
- Erector spinae plane block, Sham block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockProcedure or surgery
Ropivacaine 0.5% 20 mL at each site of ESPB
Sham blockProcedure or surgery
Skin infiltration only
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block | Experimental | The ESPB will be performed with ultrasound guidance. After identifying a suitable location between 8th and 10th thoracic spine transverse process, the overlying skin will be infiltrated with local anesthetic. A 22 gauge 90-mm needle will be inserted to make contact with the transverse process and withdraw slightly. Ropivacaine 0.5% 20 mL will be injected at this location. The same procedure will be performed on the other side.
Additionally, patients will receive acetaminophen, gabapentin and intravenous patient-controlled analgesia opioids. Receives: Procedure: Erector spinae plane block |
| Shame block | Sham comparator | A sham block will be performed by performing ultrasound examination of the back looking for intended location for ESPB placement. Skin will be infiltrated with local anesthetics but ESPB will not be performed.
Additionally, patients will receive acetaminophen, gabapentin and intravenous patient-controlled analgesia opioids. Receives: Procedure: Sham block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Postoperative opioid consumption in oral morphine equivalents
Measured: First 12 postoperative hour
Pain score
Numeric rating scale (0 - 10) for pain score, area under curve first 12 hours
Measured: First 12 postoperative hour
Secondary outcomes (6)
Length of stay in post-anesthetic recovery unit
Length of stay in post-anesthetic recovery unit
Measured: until discharge from post-anesthetic recovery unit, up to 4 hours postoperaively
Length of stay in hospital
Length of stay in hospital
Measured: until discharge from hospital, up to 7 days postoperatively
Number of participants with opioid related complication
Nausea, vomiting, pruritus
Measured: Until discharge, up to 7 days postoperatively
Number of participants with block related complication
Hematoma, nerve deficit, pneumothorax
Measured: Until discharge, up to 7 days postoperatively
Pain score 12 - 24 hour
Area under curve of Numeric rating scale(0 - 10) pain score during the 12 to 24th postoperative hour
Measured: 12th to 24th postoperative hour
Opioid consumption 12 - 24 hour
Postoperative opioid consumption in oral morphine equivalents
Measured: 12th to 24th postoperative hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start1 Sep 2019
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Why it stopped: Inability to recruit due to COVID situation and protocols
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 London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamal Kumar, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Cheng Lin, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500744
- Sponsor's protocol ID
- 111510
- Status last verified
- Oct 2023
- First submitted
- 17 Mar 2018
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery
- ClinicalTrials.gov ID
- NCT03500744
- Acronym / sponsor ID
- 111510
- Conditions
- Hysterectomy, Cystectomy, Regional Anesthesia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit due to COVID situation and protocols
- Enrolment
- 12 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 18 Apr 2018 (actual)
- 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.
Regional anesthesia, also know as a nerve block, is a key component of pain control after major abdominal surgery. Bilateral erector spinae plane block (ESPB) performed at low thoracic level has been shown to be an effective pain control method in case reports. This pilot study aims to further characterize the pain-control characteristics and to provide baseline data for future trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block | Experimental | Procedure: Erector spinae plane blockThe ESPB will be performed with ultrasound guidance. After identifying a suitable location between 8th and 10th thoracic spine transverse process, the overlying skin will be infiltrated with local anesthetic. A 22 gauge 90-mm needle will be inserted to make contact with the transverse process and withdraw slightly. Ropivacaine 0.5% 20 mL will be injected at this location. The same procedure will be performed on the other side. Additionally, patients will receive acetaminophen, gabapentin and intravenous patient-controlled analgesia opioids. |
| Shame block | Sham comparator | Procedure: Sham blockA sham block will be performed by performing ultrasound examination of the back looking for intended location for ESPB placement. Skin will be infiltrated with local anesthetics but ESPB will not be performed. Additionally, patients will receive acetaminophen, gabapentin and intravenous patient-controlled analgesia opioids. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult surgical patients who are American Society of Anesthesiologists (ASA) class I to III, undergoing cystectomy, or total abdominal hysterectomy, salpingo-oophrectomy with or without omentectomy via midline laparotomy.
Key exclusion criteria (11 listed)
- BMI > 40
- Non-English speaking
- Patient refusal or inability to consent
- Cognitive or psychiatric history that would make it difficult to assess pain score
- Pre-existing chronic pain condition
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 |
|---|---|---|
| Erector spinae plane blockRopivacaine 0.5% 20 mL at each site of ESPB | Procedure or surgery | Erector spinae plane block |
| Sham blockSkin infiltration only | Procedure or surgery | Shame block |
Primary outcome
Opioid consumption
Time frame: First 12 postoperative hour
Postoperative opioid consumption in oral morphine equivalents
Pain score
Time frame: First 12 postoperative hour
Numeric rating scale (0 - 10) for pain score, area under curve first 12 hours
6 secondary outcomes
Length of stay in post-anesthetic recovery unit
Time frame: until discharge from post-anesthetic recovery unit, up to 4 hours postoperaively
Length of stay in hospital
Time frame: until discharge from hospital, up to 7 days postoperatively
Number of participants with opioid related complication
Time frame: Until discharge, up to 7 days postoperatively
Number of participants with block related complication
Time frame: Until discharge, up to 7 days postoperatively
Pain score 12 - 24 hour
Time frame: 12th to 24th postoperative hour
Opioid consumption 12 - 24 hour
Time frame: 12th to 24th postoperative hour
Results and safety
The study was stopped early (reason given: Inability to recruit due to COVID situation and protocols). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
Cheng Lin principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block in people with Hysterectomy and Cystectomy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 11 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 5 Oct 2023. 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. Some participants in this study may receive a placebo. 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 stopped early (reason given: Inability to recruit due to COVID situation and protocols). 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?
Opioid consumption (time frame: First 12 postoperative hour). The study lists 2 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 5 Oct 2023.