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| Name | Class |
|---|---|
| National Research Oncology and Transplantology Center, Kazakhstan | OTHER |
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Prospective, single-centre, randomized, controlled, open-label, evaluator-blinded, superiority trial.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine | Experimental | Ropivacaine 0.5% - 20 ml will be administered as erector spinae plane block under ultrasound guidance |
|
| Placebo | Placebo Comparator | No injection. Bandage will be placed over the presumed site of injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | Local anesthetic for injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean cumulative opioid consumption up to 24 hours after surgery | Cumulative opioid consumption will be recorded for 24 hours following surgery | 24 hours post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain score | Numerical rating scale (0= no pain; 10= worst pain imaginable) will be used | Measured post-operatively at 0, 2, 4, 6, 8, 10, 12, 16, 20, 24 hours after surgery. |
| Time to ambulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dmitry Viderman, MD | Contact | +77055426716 | dmitry.viderman@nu.edu.kz |
| Name | Affiliation | Role |
|---|---|---|
| Philip la Fleur, RPh MSc | philip.lafleur@nu.edu.kz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center for Oncology | Astana | Kazakhstan |
Upon request, we will share information with other researchers.
Q3 and Q4 2021
Researchers on staff at an accredited university
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Bandage with tape will be placed over the presumed site of anesthetic injection
| Placebo | Other | Bandage will be placed in the presumed injection site while patients in under general anesthesia |
|
The time that the patient is able to walk independently, after surgery
| 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 | Expected time to discharge is up to 2 weeks |
| Usage of NSAIDs post surgery | Dose | Total dose used during the 24 hour period after surgery. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |