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Continuous Paravertebral Block on Postoperative Pain After Hepatectomy

Primary Purpose

Right Lobe Hepatectomy

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Continuous Paravertebral block with ropivacaine
Patient-controlled analgesia with sufentanil
Continuous Paravertebral Block with Saline
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Right Lobe Hepatectomy focused on measuring Thoracic paravertebral block, Postoperative pain, Right lobe hepatectomy, Patient controlled analgesia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PVB + PCA

Placebo PVB + PCA

Arm Description

Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with sufentanil

Continuous Paravertebral Block with Saline and Patient-controlled analgesia with sufentanil

Outcomes

Primary Outcome Measures

The cumulative opioid consumption

Secondary Outcome Measures

The pain scores determined by the numeric rating scale (NRS, 0-10)
Incidence of postoperative nausea and vomiting
Incidence of postoperative respiratory depression
Intraoperative bleeding
Postoperative hospital length of stay

Full Information

First Posted
September 18, 2012
Last Updated
August 12, 2013
Sponsor
Huazhong University of Science and Technology
Collaborators
Netherlands: Ministry of Health, Welfare and Sports
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1. Study Identification

Unique Protocol Identification Number
NCT01691937
Brief Title
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

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology
Collaborators
Netherlands: Ministry of Health, Welfare and Sports

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Right Lobe Hepatectomy
Keywords
Thoracic paravertebral block, Postoperative pain, Right lobe hepatectomy, Patient controlled analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PVB + PCA
Arm Type
Experimental
Arm Description
Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with sufentanil
Arm Title
Placebo PVB + PCA
Arm Type
Placebo Comparator
Arm Description
Continuous Paravertebral Block with Saline and Patient-controlled analgesia with sufentanil
Intervention Type
Procedure
Intervention Name(s)
Continuous Paravertebral block with ropivacaine
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Patient-controlled analgesia with sufentanil
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Continuous Paravertebral Block with Saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
The cumulative opioid consumption
Time Frame
At 24 postoperative hours
Secondary Outcome Measure Information:
Title
The pain scores determined by the numeric rating scale (NRS, 0-10)
Time Frame
At 1, 4, 8, 16, and 24 hrs after the surgery
Title
Incidence of postoperative nausea and vomiting
Time Frame
Up to 24 postoperative hrs
Title
Incidence of postoperative respiratory depression
Time Frame
Up to 24 postoperative hrs
Title
Intraoperative bleeding
Time Frame
Up to 4 hours
Title
Postoperative hospital length of stay
Time Frame
Up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuke Tian, MD.
Organizational Affiliation
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25304475
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.
Results Reference
derived

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Continuous Paravertebral Block on Postoperative Pain After Hepatectomy

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