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Clinical Trials/NCT01691937
NCT01691937
Completed
Phase 2

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

Huazhong University of Science and Technology1 site in 1 country48 target enrollmentSeptember 2012

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Right Lobe Hepatectomy
Sponsor
Huazhong University of Science and Technology
Enrollment
48
Locations
1
Primary Endpoint
The cumulative opioid consumption
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
February 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wei Mei

Associate Prof.

Huazhong University of Science and Technology

Eligibility Criteria

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)

Outcomes

Primary Outcomes

The cumulative opioid consumption

Time Frame: At 24 postoperative hours

Secondary Outcomes

  • 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)

Study Sites (1)

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