Continuous Paravertebral Block on Postoperative Pain After Hepatectomy

Phase 2

Completed

• Conditions: Right Lobe Hepatectomy
• Interventions: Procedure: Continuous Paravertebral block with ropivacaine; Procedure: Patient-controlled analgesia with sufentanil; Procedure: Continuous Paravertebral Block with Saline

• Registration Number: NCT01691937
• Lead Sponsor: Huazhong University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-18
• Study First Submitted QC: 2012-09-20
• Study First Posted: 2012-09-25
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-12
• Last Update Posted: 2013-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVB + PCA	Continuous Paravertebral block with ropivacaine	Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with sufentanil
PVB + PCA	Patient-controlled analgesia with sufentanil	Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with sufentanil
Placebo PVB + PCA	Patient-controlled analgesia with sufentanil	Continuous Paravertebral Block with Saline and Patient-controlled analgesia with sufentanil
Placebo PVB + PCA	Continuous Paravertebral Block with Saline	Continuous Paravertebral Block with Saline and Patient-controlled analgesia with sufentanil

Primary Outcome Measures

Name	Time	Method
The cumulative opioid consumption	At 24 postoperative hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China