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Continuous Paravertebral Block on Postoperative Pain After Hepatectomy

This study has been completed.
Sponsor:
Collaborator:
Netherlands: Ministry of Health, Welfare and Sports
Information provided by (Responsible Party):
Wei Mei, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01691937
First received: September 18, 2012
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Right Lobe Hepatectomy
Procedure: Continuous Paravertebral block with ropivacaine
Procedure: Patient-controlled analgesia with sufentanil
Procedure: Continuous Paravertebral Block with Saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Continuous Right Thoracic Paravertebral Block on Postoperative Pain After Right Lobe Hepatectomy

Resource links provided by NLM:


Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • The cumulative opioid consumption [ Time Frame: At 24 postoperative hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Incidence of postoperative nausea and vomiting [ Time Frame: Up to 24 postoperative hrs ] [ Designated as safety issue: Yes ]
  • Incidence of postoperative respiratory depression [ Time Frame: Up to 24 postoperative hrs ] [ Designated as safety issue: Yes ]
  • Intraoperative bleeding [ Time Frame: Up to 4 hours ] [ Designated as safety issue: Yes ]
  • Postoperative hospital length of stay [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: September 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PVB + PCA
Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with sufentanil
Procedure: Continuous Paravertebral block with ropivacaine
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.
Procedure: Patient-controlled analgesia with sufentanil
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).
Placebo Comparator: Placebo PVB + PCA
Continuous Paravertebral Block with Saline and Patient-controlled analgesia with sufentanil
Procedure: Patient-controlled analgesia with sufentanil
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).
Procedure: Continuous Paravertebral Block with Saline
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691937

Locations
China, Hubei
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Huazhong University of Science and Technology
Netherlands: Ministry of Health, Welfare and Sports
Investigators
Study Chair: Yuke Tian, MD. Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
  More Information

No publications provided

Responsible Party: Wei Mei, Associate Prof., Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01691937     History of Changes
Other Study ID Numbers: TJMZK20120302
Study First Received: September 18, 2012
Last Updated: August 12, 2013
Health Authority: China: Ministry of Health

Keywords provided by Huazhong University of Science and Technology:
Thoracic paravertebral block
Postoperative pain
Right lobe hepatectomy
Patient controlled analgesia

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Ropivacaine
Sufentanil
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014