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Continuous Paravertebral Block on Postoperative Pain After Hepatectomy

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01691937
Enrollment
48
Registered
2012-09-25
Start date
2012-09-30
Completion date
2013-02-28
Last updated
2013-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Right Lobe Hepatectomy

Keywords

Thoracic paravertebral block, Postoperative pain, Right lobe hepatectomy, Patient controlled analgesia

Brief 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.

Interventions

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.

PROCEDUREPatient-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).

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.

Sponsors

Netherlands: Ministry of Health, Welfare and Sports
CollaboratorOTHER_GOV
Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
The cumulative opioid consumptionAt 24 postoperative hours

Secondary

MeasureTime 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 vomitingUp to 24 postoperative hrs
Incidence of postoperative respiratory depressionUp to 24 postoperative hrs
Intraoperative bleedingUp to 4 hours
Postoperative hospital length of stayUp to 6 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026