Continuous Paravertebral Block on Postoperative Quality of Recovery After Hepatectomy

Effect of Continuous Paravertebral Block on Postoperative Quality of Recovery After Hepatectomy

Moderate to severe postoperative pain often influence patients quality of recovery after hepatectomy. Systemic opioids given with patient-controlled analgesia has been used after hepatectomy in many medical center, but the analgesic effect can be limited and undesirable side effects may bring about negative effects on patients recovery. Regional block has been proved to improve patients postoperative recovery in many kinds of surgeries.

The investigators therefore designed a prospective, randomized, subject and assessor blinded, parallel-group, placebo controlled study to test the hypothesis that continuous right thoracic paravertebral block increase patients quality of recovery score on the 7th postoperative day after hepatectomy in patients receiving i.v. patient-controlled analgesia (PCA) with morphine.

Study Overview

• Status: Completed
• Conditions: Nerve Block
• Intervention / Treatment: Procedure: Continuous Paravertebral block with ropivacaine; Drug: Patient-controlled analgesia with morphine; Procedure: Continuous Paravertebral Block with Saline

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

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking Union Medical College Hospital

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: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TPVB + PCA; Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with morphine	Procedure: Continuous Paravertebral block with ropivacaine; 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 Device: PAJUNK Contiplex S Catheter Drug: single dose ropivacaine 0.5%ropivacaine 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, infusion rate: 0.125ml/kg/pulse,1pulse/h given through the catheter inserted in the T8 paravertebral space following the single dose Drug: Morphine given as IPCA bolus: 2mg, lock time: 5min, 1h limitation: 8mg; Drug: Patient-controlled analgesia with morphine; Drug: Morphine given as IPCA bolus: 2mg, lock time: 5min, 1h limitation: 8mg
Placebo Comparator: placebo TPVB + PCA; Continuous Paravertebral Block with Saline and Patient-controlled analgesia with morphine	Drug: Patient-controlled analgesia with morphine; Drug: Morphine given as IPCA bolus: 2mg, lock time: 5min, 1h limitation: 8mg; Procedure: Continuous Paravertebral Block with Saline; 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 Device: PAJUNK Contiplex S Catheter Drug: single dose saline,25ml in total given immediately after the correct position of the tip of the needle has been confirmed Drug: continuously infusion of saline 0.9% saline, infusion rate: 0.125ml/kg/pulse,1pulse/h given through the catheter inserted in the T8 paravertebral space following the single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the postoperative recovery quality on postoperative day 7	The postoperative recovery quality is evaluated with QoR-15 questionnaire. The QoR-15 is a 15-item questionnaire intended to measure QoR after anesthesia and surgery. It comprises five subscales: pain (2 items), physical comfort (5 items), physical independence (2 items), psychological support (2 items), and emotional state (4 items) [2 Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR- 15. Anesthesiology. 2013;118(6):1332.]. Each item is scored from 0 to 10, and the possible total score ranges from 0(extremely poor quality of recovery) to 150 (excellent quality of re covery).	at the 7th postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cumulated morphine consumption		At 8, 24,48 hours after the surgery
time to resumption of bowel movement		Up to 2 weeks after surgery
time to out-of bed activity/ambutation		Up to 2 weeks
post operative length of stay		Up to 2 weeks
The pain scores determined by the numeric rating scale (NRS, 0-10)	The patients evaluated their pain severity with thenumeric rating scale (NRS, 0-10),where 0 indicates no pain, and 10 indicates the most severe pain.	At 8, 24,48 hours after the surgery
the postoperative recovery quality on postoperative day 3: QoR-15 questionnaire	The postoperative recovery quality is evaluated with QoR-15 questionnaire. The QoR-15 is a 15-item questionnaire intended to measure QoR after anesthesia and surgery. It comprises five subscales: pain (2 items), physical comfort (5 items), physical independence (2 items), psychological support (2 items), and emotional state (4 items) [2 Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR- 15. Anesthesiology. 2013;118(6):1332.]. Each item is scored from 0 to 10, and the possible total score ranges from 0(extremely poor quality of recovery) to 150 (excellent quality of re covery).	at the 3th postoperative day

Collaborators and Investigators

• Sponsor: Cui Xulei

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): May 12, 2019
• Study Completion (Actual): May 19, 2019

Study Registration Dates

• First Submitted: December 10, 2018
• First Submitted That Met QC Criteria: December 13, 2018
• First Posted (Actual): December 17, 2018

Study Record Updates

• Last Update Posted (Actual): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: June 1, 2020

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: cuixulei7

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No