Continuous Paravertebral Block on Postoperative Pain After Hepatectomy

Right Lobe Hepatectomy Clinical Trial

Official title:

Continuous Right Thoracic Paravertebral Block on Postoperative Pain After Right Lobe Hepatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01691937
• Other study ID #: TJMZK20120302
• Status: Completed
• Phase: Phase 2
• First received: September 18, 2012
• Last updated: August 12, 2013
• Start date: September 2012
• Est. completion date: February 2013

Study information

• Verified date: August 2013
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 18-70 yrs

• American Society of Anesthesiologists physical status?-?

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Right Lobe Hepatectomy

Intervention

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.
• 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).
• 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.

Locations

Country	Name	City	State
China	Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	Netherlands: Ministry of Health, Welfare and Sports

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cumulative opioid consumption		At 24 postoperative hours	No
Secondary	The pain scores determined by the numeric rating scale (NRS, 0-10)		At 1, 4, 8, 16, and 24 hrs after the surgery	No
Secondary	Incidence of postoperative nausea and vomiting		Up to 24 postoperative hrs	Yes
Secondary	Incidence of postoperative respiratory depression		Up to 24 postoperative hrs	Yes
Secondary	Intraoperative bleeding		Up to 4 hours	Yes
Secondary	Postoperative hospital length of stay		Up to 6 weeks	Yes