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| Name | Class |
|---|---|
| Netherlands: Ministry of Health, Welfare and Sports | OTHER_GOV |
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Patients often experience moderate to severe postoperative pain, especially during the first hours after hepatectomy. Systemic opioids given with patient-controlled analgesia has be used after hepatectomy in many medical center(Aubrun, Monsel et al. 2001; Aubrun, Salvi et al. 2005), but the analgesic effect can be limited and undesirable side effects may occur.
A case report described that right thoracic paravertebral block reduced pain and analgesic requirements after right lobe hepatectomy(Ho, Karmakar et al. 2004). Compared with epidural analgesia, thoracic paravertebral block probably carries a much lower risk of spinal haematoma in the presence of moderate haemostatic deficiencies (Richardson and Lonnqvist 1998; Karmakar 2001).
We therefore designed a prospective, randomized, subject and assessor blinded, parallel-group, placebo controlled study to test the hypothesis that continuous right thoracic paravertebral analgesia decreases opioid consumption during the first 24 h after right lobe hepatectomy in patients receiving i.v. patient-controlled analgesia (PCA) with sufentanil.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVB + PCA | Experimental | Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with sufentanil |
|
| Placebo PVB + PCA | Placebo Comparator | Continuous Paravertebral Block with Saline and Patient-controlled analgesia with sufentanil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Paravertebral block with ropivacaine | Procedure | Before anesthesia, continuous right thoracic paravertebral block of T7 is performed. After injection of 5 mL normal saline, a catheter (PAJUNK, Geisingen, Germany) is advanced medially the estimated distance to the paravertebral space. After injection of 1% lidocaine 15ml, the block level is tested by pinprick and recorded 15 minutes later. At the end of operation, syringe contained 0.2% ropivacaine is connected to paravertebral catheter, a 10ml bolus of 0.2% ropivacaine is injected via the paravertebral catheter, followed by an infusion of ropivacaine 0.2% at 6 ml/h for postoperative pain management. |
| Measure | Description | Time Frame |
|---|---|---|
| The cumulative opioid consumption | At 24 postoperative hours |
| Measure | Description | Time Frame |
|---|---|---|
| The pain scores determined by the numeric rating scale (NRS, 0-10) | At 1, 4, 8, 16, and 24 hrs after the surgery | |
| Incidence of postoperative nausea and vomiting | Up to 24 postoperative hrs | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuke Tian, MD. | Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25304475 | Derived | Chen H, Liao Z, Fang Y, Niu B, Chen A, Cao F, Mei W, Tian Y. Continuous right thoracic paravertebral block following bolus initiation reduced postoperative pain after right-lobe hepatectomy: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2014 Nov-Dec;39(6):506-12. doi: 10.1097/AAP.0000000000000167. |
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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 |
| D016058 | Analgesia, Patient-Controlled |
| D017409 | Sufentanil |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Patient-controlled analgesia with sufentanil | Procedure | Once arrival at the PACU, all patients were placed on a postoperative analgesic regimen that included patient-controlled analgesia with intravenous sufentanil (bolus 1μg, lockout time 10 min) and tramadol 100 mg IV for severe pain (NRS 6-10). |
|
| Continuous Paravertebral Block with Saline | Procedure | Before anesthesia, continuous right thoracic paravertebral block of T7 is performed. After injection of 5 mL normal saline, a catheter (PAJUNK, Geisingen, Germany) is advanced medially the estimated distance to the paravertebral space. After injection of 1% lidocaine 15ml, the block level is tested by pinprick and recorded 15 minutes later. At the end of operation, syringe contained 0.9% saline is connected to paravertebral catheter, a 10ml bolus of 0.9% saline is injected via the paravertebral catheter, followed by an infusion of 0.9% saline at 6 ml/h for postoperative pain management. |
|
| Incidence of postoperative respiratory depression |
| Up to 24 postoperative hrs |
| Intraoperative bleeding | Up to 4 hours |
| Postoperative hospital length of stay | Up to 6 weeks |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |