Trials / Completed
CompletedNCT01691937
Continuous Paravertebral Block on Postoperative Pain After Hepatectomy
Continuous Right Thoracic Paravertebral Block on Postoperative Pain After Right Lobe Hepatectomy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Huazhong University of Science and Technology · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Continuous Paravertebral block with ropivacaine | 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. |
| PROCEDURE | Patient-controlled analgesia with sufentanil | 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). |
| PROCEDURE | Continuous Paravertebral Block with Saline | 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. |
Timeline
- Start date
- 2012-09-01
- Primary completion
- 2013-02-01
- Completion
- 2013-02-01
- First posted
- 2012-09-25
- Last updated
- 2013-08-13
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT01691937. Inclusion in this directory is not an endorsement.