Continuous Right Thoracic Paravertebral Block on Postoperative Pain After Right Lobe Hepatectomy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- The cumulative opioid consumption
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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)
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)
Investigators
Wei Mei
Associate Prof.
Huazhong University of Science and Technology