Pain, PostoperativePhase 3NCT04702685
Erector Spinae Plane Block With Ropivacaine for Major Upper Abdominal Surgery
A Phase 3 study testing Ropivacaine in people with Pain, Postoperative, run by Nazarbayev University Medical Center at 1 site in Kazakhstan.
Trial summary
Prospective, single-centre, randomized, controlled, open-label, evaluator-blinded, superiority trial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteKazakhstan
- Study dates
- Jan 2021to Aug 2021
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults who are scheduled to undergo major upper abdominal surgery (e.g. Pancreato-duodenal resection). If enrollment rates are insufficient, patients undergoing other major upper abdominal surgery will be enrolled (e.g in the supraumbilical area: liver resection, colon resection; Whipple procedure; gastrectomy).
- Males or females 18-70 years of age
- American Society of Anesthesiologists physical status class I,II, III
- Signed informed consent
Who cannot join
- Patients undergoing emergency surgery
- Decompensated cardiovascular disease (e.g. left ventricular ejection fraction ≤40%), chronic heart failure, rhythm and conduction disorders, coagulopathies)
- Comorbid obesity (BMI≥35kg/m2)
- Anomalies of vertebral column
- Use of anticoagulants and patients with hypocoagulable conditions
- Pregnancy
Show all 9Show fewer
- Physician preference for therapeutic anticoagulation
- Infection of skin at site of needle puncture
- Known allergies to study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized, Parallel Group Study to Evaluate the Efficacy of Ropivacaine Administered by Ultrasound-guided Erector Spinae Plane Block for Major Upper Abdominal Surgery
Prospective, single-centre, randomized, controlled, open-label, evaluator-blinded, superiority trial.
Read the detailed description
The primary objective is to establish whether ESP ropivacaine reduces post-operative opioid use and improves pain rating post-operatively. The secondary objectives include adverse event incidence, time to ambulation and time to discharge.
- Conditions
- Pain, Postoperative
- Being tested
- Ropivacaine, Placebo
- Keywords
- ropivacaine, major upper abdominal surgery, supraumbilical, liver resection, colon resection, Whipple procedure, gastrectomy, anesthetics, local, erector spinae plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Naropin
Local anesthetic for injection
PlaceboOther
Bandage will be placed in the presumed injection site while patients in under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Experimental | Ropivacaine 0.5% - 20 ml will be administered as erector spinae plane block under ultrasound guidance Receives: Drug: Ropivacaine |
| Placebo | Placebo comparator | No injection. Bandage will be placed over the presumed site of injection Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean cumulative opioid consumption up to 24 hours after surgery
Cumulative opioid consumption will be recorded for 24 hours following surgery
Measured: 24 hours post-operation
Secondary outcomes (4)
Post-operative pain score
Numerical rating scale (0= no pain; 10= worst pain imaginable) will be used
Measured: Measured post-operatively at 0, 2, 4, 6, 8, 10, 12, 16, 20, 24 hours after surgery.
Time to ambulation
The time that the patient is able to walk independently, after surgery
Measured: Between surgery and discharge from hospital, expected time is between 1 day to 1 week
Time to discharge
From time of surgery completion to discharge from hospital
Measured: Expected time to discharge is up to 2 weeks
Usage of NSAIDs post surgery
Dose
Measured: Total dose used during the 24 hour period after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study startJan 2021 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nazarbayev University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Oncology and Transplantology Center, Kazakhstan
- Responsible party
- Sponsor
- Investigators
- Philip la Fleur, RPh MSc, Principal investigator, philip.lafleur@nu.edu.kz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702685
- Sponsor's protocol ID
- ESP1
- Status last verified
- Dec 2020
- First submitted
- 3 Dec 2020
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request, we will share information with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Parallel Group Study to Evaluate the Efficacy of Ropivacaine Administered by Ultrasound-guided Erector Spinae Plane Block for Major Upper Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04702685
- Acronym / sponsor ID
- ESP1
- Conditions
- Pain, Postoperative
- Keywords
- ropivacaine, major upper abdominal surgery, supraumbilical, liver resection, colon resection, Whipple procedure, gastrectomy, anesthetics, local
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nazarbayev University Medical CenterUniversity, hospital or other
- Collaborators
- National Research Oncology and Transplantology Center, Kazakhstan
- Study start
- Jan 2021 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 11 Jan 2021 (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.
Prospective, single-centre, randomized, controlled, open-label, evaluator-blinded, superiority trial.
Detailed description
The primary objective is to establish whether ESP ropivacaine reduces post-operative opioid use and improves pain rating post-operatively. The secondary objectives include adverse event incidence, time to ambulation and time to discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Experimental | Drug: RopivacaineRopivacaine 0.5% - 20 ml will be administered as erector spinae plane block under ultrasound guidance |
| Placebo | Placebo comparator | Other: PlaceboNo injection. Bandage will be placed over the presumed site of injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults who are scheduled to undergo major upper abdominal surgery (e.g. Pancreato-duodenal resection). If enrollment rates are insufficient, patients undergoing other major upper abdominal surgery will be enrolled (e.g in the supraumbilical area: liver resection, colon resection; Whipple procedure; gastrectomy).
- Males or females 18-70 years of age
- American Society of Anesthesiologists physical status class I,II, III
- Signed informed consent
Key exclusion criteria (9 listed)
- Patients undergoing emergency surgery
- Decompensated cardiovascular disease (e.g. left ventricular ejection fraction ≤40%), chronic heart failure, rhythm and conduction disorders, coagulopathies)
- Comorbid obesity (BMI≥35kg/m2)
- Anomalies of vertebral column
- Use of anticoagulants and patients with hypocoagulable conditions
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 |
|---|---|---|
| RopivacaineAlso: NaropinLocal anesthetic for injection | Drug | Ropivacaine |
| PlaceboBandage will be placed in the presumed injection site while patients in under general anesthesia | Other | Placebo |
Primary outcome
Mean cumulative opioid consumption up to 24 hours after surgery
Time frame: 24 hours post-operation
Cumulative opioid consumption will be recorded for 24 hours following surgery
4 secondary outcomes
Post-operative pain score
Time frame: Measured post-operatively at 0, 2, 4, 6, 8, 10, 12, 16, 20, 24 hours after surgery.
Time to ambulation
Time frame: Between surgery and discharge from hospital, expected time is between 1 day to 1 week
Time to discharge
Time frame: Expected time to discharge is up to 2 weeks
Usage of NSAIDs post surgery
Time frame: Total dose used during the 24 hour period after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Individual participant dataSharing planned: Yes. Upon request, we will share information with other researchers.
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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.
Philip la Fleur, RPh MSc principal investigator
philip.lafleur@nu.edu.kz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ropivacaine in people with Pain, Postoperative, run by Nazarbayev University Medical Center at 1 site in Kazakhstan.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 11 Jan 2021. 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 Kazakhstan. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dmitry Viderman, MD (+77055426716, dmitry.viderman@nu.edu.kz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean cumulative opioid consumption up to 24 hours after surgery (time frame: 24 hours post-operation). 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 11 Jan 2021.