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The study aims to assess the interfacial plane blocks' effect on pain level, course of postoperative rehabilitation, and anti-inflammatory analgesic effect.
This study evaluates the analgesic efficacy in adults of bilevel, bilateral erector spinae plane (ESP) blocks after posterior cervical spinal fusion surgery by assessing postoperative pain scores and opiate requirements as the primary outcome measures. We aim to investigate how ESP blocks, performed under ultrasound guidance at the two vertebral levels, contribute to postoperative pain control. This will be determined by measuring numerical rating pain scores repeatedly following surgery and opiate consumption until the patient is discharged from the hospital. These primary outcome measures will be compared between a treatment group of participants receiving ESP blocks and a control group receiving a sham block. Our primary hypothesis is that ESP blocks significantly reduce postoperative pain and opiate requirements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham group | Sham Comparator | Bilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0,9% normal saline |
|
| ESPB group | Active Comparator | Bilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0.2% Ropivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.9%sodium chloride | Drug | Bilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0,9% normal saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| first need of opiate | Time after surgery when the patient needs opiate for the first time | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption | Total opiate consumption after surgery | 48 hours |
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malgorzata Domagalska, Ph.D. | Poznań University of Medical Science | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poznan University of Medical Sciences | Poznan | Poznań | 61-701 | Poland |
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| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| 0.2% ropivacaine | Drug | Bilateral ESPB under ultrasound guidance (adjusted to the incision line): 2 x 20ml/kg 0,2% ropivacaine |
|
|
| 4 hours after surgery |
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 8 hours after surgery |
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 12 hours after surgery |
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 16 hours after surgery |
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 20 hours after surgery |
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 24 hours after surgery |
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 36 hours after surgery |
| Numerical Rating Scale [range 0:10] | NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) | 48 hours after surgery |
| NLR | Neutrophil-to-lymphocyte ratio | 12 hours after surgery |
| NLR | Neutrophil-to-lymphocyte ratio | 24 hours after surgery |
| NLR | Neutrophil-to-lymphocyte ratio | 48 hours after surgery |
| PLR | Platet-to-lymphocyte ratio | 12 hours after surgery |
| PLR | Platet-to-lymphocyte ratio | 24 hours after surgery |
| PLR | Platet-to-lymphocyte ratio | 48 hours after surgery |
| D017670 |
| Sodium Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |