Clinical trial NCT01691937: Continuous Paravertebral Block on Postoperative Pain After Hepatectomy
Official title: Continuous Right Thoracic Paravertebral Block on Postoperative Pain After Right Lobe Hepatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Right Lobe Hepatectomy
Keywords: Thoracic paravertebral block
Postoperative pain
Right lobe hepatectomy
Patient controlled analgesia
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Netherlands: Ministry of Health, Welfare and Sports
First posted: 2012-09-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: The cumulative opioid consumption
timeFrame: At 24 postoperative hours
Secondary outcomes:
measure: The pain scores determined by the numeric rating scale (NRS, 0-10)
timeFrame: At 1, 4, 8, 16, and 24 hrs after the surgery
measure: Incidence of postoperative nausea and vomiting
timeFrame: Up to 24 postoperative hrs
measure: Incidence of postoperative respiratory depression
timeFrame: Up to 24 postoperative hrs
measure: Intraoperative bleeding
timeFrame: Up to 4 hours
measure: Postoperative hospital length of stay
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Yuke Tian, MD.
role: STUDY_CHAIR
References:
citation: Chen H, Liao Z, Fang Y, Niu B, Chen A, Cao F, Mei W, Tian Y. Continuous right thoracic paravertebral block following bolus initiation reduced postoperative pain after right-lobe hepatectomy: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2014 Nov-Dec;39(6):506-12. doi: 10.1097/AAP.0000000000000167.