Continuous Paravertebral Block on Postoperative Pain After Hepatectomy

Study Overview
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Brief Summary
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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.

Official Title
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Continuous Right Thoracic Paravertebral Block on Postoperative Pain After Right Lobe Hepatectomy

Conditions
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Right Lobe Hepatectomy

Intervention / Treatment
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* Procedure: Continuous Paravertebral block with ropivacaine
* Procedure: Patient-controlled analgesia with sufentanil
* Procedure: Continuous Paravertebral Block with Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-70 yrs American Society of Anesthesiologists physical statusⅠ-Ⅲ Undergo right lobe hepatectomy Informed consent Exclusion Criteria: A known allergy to the drugs being used Coagulopathy, on anticoagulants Analgesics intake, history of substance abuse Participating in the investigation of another experimental agent Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PVB + PCA<br>Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with sufentanil | Procedure: Continuous Paravertebral block with ropivacaine<br>* 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.<br>Procedure: Patient-controlled analgesia with sufentanil<br>* 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).<br>|
| Placebo Comparator: Placebo PVB + PCA<br>Continuous Paravertebral Block with Saline and Patient-controlled analgesia with sufentanil | Procedure: Patient-controlled analgesia with sufentanil<br>* 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).<br>Procedure: Continuous Paravertebral Block with Saline<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cumulative opioid consumption |  | At 24 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient controlled analgesia, Thoracic paravertebral block, Postoperative pain, Right lobe hepatectomy