Programmed Intermittent Bolus Infusion of Thoracic Paravertebral Block for Hepatectomy

Early and Late Postoperative Analgesia and Recovery Effects of Programmed Intermittent Bolus Infusion of Thoracic Paravertebral Block for Hepatectomy: A Prospective, Randomized, Double-blinded, Controlled Study

Hepatectomy induces moderate to severe postoperative pain. Patient-controlled intravenous analgesia has been used in many medical centers for post-hepatectomy analgesia, but the effects are limited and often cause undesirable adverse effects.

Regional Block has been used for postoperative analgesia in many surgeries. Some studies suggest that regional analgesia has an opioid-sparing effect and can reduce the incidence of chronic pain. Also, the programmed intermittent bolus infusion is better than continuous infusion, with less analgesic consumption and fewer adverse effects.

Studies on the early and late postoperative analgesia and recovery effects of paravertebral block for open hepatectomy are scarce. Therefore, the investigators aim to conduct a prospective, randomized, subject and assessor-blinded, parallel-group, placebo-controlled study to test the hypothesis that the programmed intermittent bolus infusion of right thoracic paravertebral block reduces postoperative intravenous analgesic use and pain scores and improved patients' satisfaction.

Study Overview

• Status: Completed
• Conditions: Analgesia; Hepatectomy; Paravertebral Block; Postoperative Recovery
• Intervention / Treatment: Procedure: Paravertebral block-ropivacaine; Drug: patient controlled analgesia with morphine; Procedure: Paravertebral block-saline

Detailed Description

This study aims to compare the early postoperative morphine consumptions, pain scores, rescue analgesics, adverse effects and recovery indices, and the late postoperative life quality between patients with and without paravertebral block.

• 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
• Unable to cooperate, eg. inability to properly describe postoperative pain to investigators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PTPVB-ropivacaine; Programmed intermittent bolus infusion of a thoracic paravertebral block with ropivacaine and patient-controlled analgesia with morphine	Procedure: Paravertebral block-ropivacaine; Inject 25 ml 0.5% ropivacaine in the T8 paravertebral space followed with catheter insertion and continuous 0.2% ropivacaine infusion(infusion rate: 0.125ml/kg/pulse,1pulse/h); Other Names: PVB group; Drug: patient controlled analgesia with morphine; Morphine was given as intravenous patient-controlled analgesia bolus: 1-2mg, lock time: 5min, 1h limitation: 8mg; Other Names: PCIA
PLACEBO_COMPARATOR: PTPVB-saline; Programmed intermittent bolus infusion of a thoracic paravertebral block with saline and patient-controlled analgesia with morphine	Drug: patient controlled analgesia with morphine; Morphine was given as intravenous patient-controlled analgesia bolus: 1-2mg, lock time: 5min, 1h limitation: 8mg; Other Names: PCIA; Procedure: Paravertebral block-saline; Inject 25 ml 0.9% saline in the T8 paravertebral space followed with catheter insertion and continuous 0.9% saline infusion(infusion rate: 0.125ml/kg/pulse,1pulse/h); Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative 48hrs morphine	Cumulate morphine consumption 48 hours after hepatectomy	Postoperative 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	The average value of the heart rate during the operation measured at 10 minutes interval	During the operation
Mean blood pressure	The average value of the mean blood pressure (=1/3 systolic pressure + 2/3 diastolic pressure) during the operation measured at 10 minutes interval.	During the operation
Sevoflurane concentration	The average value of the sevoflurane concentration during the operation measured at 10 minutes interval	During the operation
Intraoperative medication dose	Doses of fentanyl, ephedrine, atrophin, phylepherine and urapidil used during the operation	During the operation
Fluid volumes	Fluid volumes including volumes of crystalloid, colloid, red blood cells, plasma, platelet, Urine and hemorrhage.	During the operation
Awake and extubation time	Time from stop of sevoflurane use to patient awake and extubation.	At the end of the operation
Postoperative morphine consumption	Cumulative morphine consumption at 2, 4, 12, 24 hours after hepatectomy	Postoperative 2, 4, 12, 24hours
Operation time	Time from the start to the end of the operation	During the operation
The pain scores(at rest and with cough) determined by the numeric rating scale	NRS is an internationally recognized pain scale with 11 points ranging from 0 to 10 points, with 0 defined as no pain and 10 defined as the worst pain imaginable.	Postoperative 0, 2, 4, 12, 24 and 48 hours
Adverse effects	Adverse effects of morphine including nausea, vomiting, pruritus and respiratory depression, bowel movement and Foley catheter removal.	Postoperative 0-48 hours
Rescue analgesia	Times of rescue analgesia	Postoperative 0-48hours
Postoperative recovery indices	Postoperative recovery indices including drowsiness, thirsty, cold feeling, cognitive decline and shiver evaluated using a 0-3 points Likert scale, with 0 defined as none, 1 defined as mild, 2 defined as moderate and 3 defined as severe.	Postoperative 48 hours
Satisfaction indices	Emergence, analgesia and overall satisfaction evaluated using a 1-5 points Likert scale, with 1 defined as very unsatisfied, 2 defined as unsatisfied, 3 defined as no comments, 4 defined as satisfied and 5 defined as very satisfied.	Postoperative 48 hours
Length of hospital stay	Number of in-hospital days from admission to discharge	Two weeks after hospital discharge
Chronic recovery data	Chronic recovery data including incidence of pain, numbness, hypoesthesia and sleep disorder	Postoperative 3 months
Chronic pain characteristics	Incidence of difference types of pain including throbbing, aching, pricking and stabbing.	Postoperative 3 months
Chronic pain NRS score	NRS is an internationally recognised pain scale with 11 points ranging from 0 to 10 points, with 0 defined as no pain and 10 defined as the worst pain imaginable.	Postoperative 3 months

Collaborators and Investigators

• Sponsor: Cui Xulei

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 10, 2020
• Primary Completion (ACTUAL): June 10, 2021
• Study Completion (ACTUAL): December 10, 2021

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (ACTUAL): March 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

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: PTPVB-H

Drug and device information, study documents

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