Paravertebral Block on Postoperative Pain After Hepatectomy - Full Text View

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, randomised, subject and assessor blinded, parallel-group, 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: Paravertebral block with ropivacaine Procedure: Patient-controlled analgesia with sufentanil	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:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Sufentanil citrate Ropivacaine monohydrochloride

U.S. FDA Resources

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 Paravertebral block (PVB) with 0.2% ropivacaine and Patient-controlled analgesia (PCA) with sufentanil	Procedure: Paravertebral block with ropivacaine Before anesthesia, continuous right thoracic paravertebral block of T7 is performed under ultrasound guidance with a linear 6- to 13-MHz ultrasound transducer (Sonosite M-Turbo, USA) in the lateral position via a percutaneous intercostals approach. After injection of 15 mL lidocaine 1%, a catheter (PAJUNK, Geisingen, Germany) is advanced medially the estimated distance to the paravertebral space. 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 1% lidocaine 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 every 6 hrs for severe pain (NRS 6-10).
Active Comparator: PCA Patient-controlled analgesia (PCA) 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 every 6 hrs for severe pain (NRS 6-10).

Arms

Assigned Interventions

Experimental: PVB + PCA

Paravertebral block (PVB) with 0.2% ropivacaine and Patient-controlled analgesia (PCA) with sufentanil

Procedure: Paravertebral block with ropivacaine

Before anesthesia, continuous right thoracic paravertebral block of T7 is performed under ultrasound guidance with a linear 6- to 13-MHz ultrasound transducer (Sonosite M-Turbo, USA) in the lateral position via a percutaneous intercostals approach. After injection of 15 mL lidocaine 1%, a catheter (PAJUNK, Geisingen, Germany) is advanced medially the estimated distance to the paravertebral space. 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 1% lidocaine 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 every 6 hrs for severe pain (NRS 6-10).

Active Comparator: PCA

Patient-controlled analgesia (PCA) 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 every 6 hrs for severe pain (NRS 6-10).

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

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:	February 25, 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
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ropivacaine
Sufentanil
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Analgesics
Adjuvants, Anesthesia
Narcotics
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on June 17, 2013