Continuous Paravertebral Block on Postoperative Pain After Hepatectomy

Huazhong University of Science and Technology

Status and phase: Completed; Phase 2

Conditions: Right Lobe Hepatectomy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01691937

TJMZK20120302

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups, including a placebo group

PVB + PCA

Experimental group

Description:

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

Treatment:

Procedure: Patient-controlled analgesia with sufentanil

Procedure: Continuous Paravertebral block with ropivacaine

Placebo PVB + PCA

Placebo Comparator group

Description:

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

Treatment:

Procedure: Continuous Paravertebral Block with Saline

Procedure: Patient-controlled analgesia with sufentanil