Thoracic Paravertebral Block : Effect on Acute Pain and Chronic Pain of Hepatectomy With Right J-shape Subcostal Incision

This prospective, randomized study,control study aims to compare the analgesic effect,opioids consumption,quality of recovery,length of hospital stay and incidence of chronic pain,et al. single-injection TPVB +continuous(pulsatile infusion) TPVB and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing hepatectomy with right J-shape subcostal incision.

Study Overview

• Status: Completed
• Conditions: Analgesia; Hepatectomy; Nerve Block
• Intervention / Treatment: Device: PAJUNK Contiplex S Catheter; Procedure: single-injection TPVB + continuous TPVB; Device: Philip CX50 Ultrasound Scanner; Drug: single dose ropivacaine; Drug: continuously infusion of ropivacaine; Drug: Morphine given as IPCA

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Xulei CUI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-70 yrs
• American Society of Anesthesiologists physical statusⅠ-Ⅲ
• Undergo hepatectomy with J-shape subcostal incision
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IPCA; postoperative IPCA is given alone	Drug: Morphine given as IPCA; bolus: 2mg, lock time: 10min, 1h limitation: 8mg
Experimental: Single-injection TPVB +continuous TPVB; Single-injection of TPVB is given preoperatively followed with continuous infusion+ postoperative IPCA.	Device: PAJUNK Contiplex S Catheter; Procedure: single-injection TPVB + continuous TPVB; Inject local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion.; Device: Philip CX50 Ultrasound Scanner; The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning; Drug: single dose ropivacaine; 2mg/kg ropivacaine in saline with 1:200,000 adrenaline, 25ml in total; given immediately after the correct position of the tip of the needle has been confirmed; Drug: continuously infusion of ropivacaine; 0.2% ropivacaine, pulse dosadge: 0.125ml/kg/pulse, 1pulse/h at a rate of 6ml/minutes; given through the catheter inserted in the T8 paravertebral space following the single dose; Drug: Morphine given as IPCA; bolus: 2mg, lock time: 10min, 1h limitation: 8mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cumulative morphine consumption	within 48 postoperative hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ambulation time		within the 7 days after surgery
patient satisfaction with anesthesia	use the Chinese version Bauer questionnaire to assess the patient satisfaction with anesthesia	48 hours after surgery
The pain scores determined by the numeric rating scale (NRS, 0-10)		At 0, 2,4, 8, 12, 24 ,48,72hours and 7day after the surgery
nausea and vomiting score		At 0, 2,4, 8, 12, 24 and 48hours after the surgery
pruritus score		At 0, 2,4, 8, 12, 24 and 48hours after the surgery
time of recovery of bowl movement		within the 7 days after surgery
Postoperative hospital length of stay		Up to 4 weeks
data collection of chronic pain	Patients undergo a telephone interview with a questionnaire at 3, 6 and 12 months after surgery, the incidence and severity of chronic pain is recorded.	at 3,6,12 months after surgery

Collaborators and Investigators

• Sponsor: Cui Xulei
• Investigators: Study Chair: Yuguang Huang, MD., Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: June 22, 2016
• First Submitted That Met QC Criteria: June 25, 2016
• First Posted (Estimate): June 29, 2016

Study Record Updates

• Last Update Posted (Actual): January 8, 2019
• Last Update Submitted That Met QC Criteria: January 6, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Ropivacaine; Morphine
• Other Study ID Numbers: cuixulei2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO