Continuous Paravertebral Block on Postoperative Pain After Hepatectomy

NCT01691937 | Completed Phase 2 DMC

• 1 other identifier: TJMZK20120302
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Right Lobe Hepatectomy

Keywords

Thoracic paravertebral block; Postoperative pain; Right lobe hepatectomy; Patient controlled analgesia

Outcome Measures

Primary Outcomes (1)

• The cumulative opioid consumption

  At 24 postoperative hours

Secondary Outcomes (5)

• 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

Study Arms (2)

PVB + PCA

EXPERIMENTAL

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

Procedure: Continuous Paravertebral block with ropivacaine; Procedure: Patient-controlled analgesia with sufentanil

Placebo PVB + PCA

PLACEBO COMPARATOR

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

Procedure: Patient-controlled analgesia with sufentanil; Procedure: Continuous Paravertebral Block with Saline

Interventions

Continuous Paravertebral block with ropivacaine PROCEDURE

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.

PVB + PCA

Patient-controlled analgesia with sufentanil PROCEDURE

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).

PVB + PCA; Placebo PVB + PCA

Continuous Paravertebral Block with Saline PROCEDURE

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.

Placebo PVB + PCA

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 yrs
• American Society of Anesthesiologists physical statusⅠ-Ⅲ
• Undergo right lobe hepatectomy
• Informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• Netherlands: Ministry of Health, Welfare and Sports: collaborator

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

Related Publications (1)

• 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.

  PMID: 25304475 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Analgesia, Patient-Controlled; Sufentanil; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Analgesia; Anesthesia and Analgesia; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Yuke Tian, MD.

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof.

Study Record Dates

• First Submitted: September 18, 2012
• First Posted: September 25, 2012
• Study Start: September 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: August 13, 2013

Record last verified: 2013-08

Locations

CN (1)