Programmed Intermittent Bolus Infusion of Thoracic Paravertebral Block for Hepatectomy

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04304274
• Other study ID #: PTPVB-H
• Status: Completed
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: December 10, 2021

Study information

• Verified date: February 2022
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 10, 2021
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 18-70 yrs

• American Society of Anesthesiologists physical status?-?

• 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

Related Conditions & MeSH terms

• Analgesia
• Hepatectomy
• Paravertebral Block
• Postoperative Recovery

Intervention

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)
• 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)

Drug:
• patient controlled analgesia with morphine
Morphine was given as intravenous patient-controlled analgesia bolus: 1-2mg, lock time: 5min, 1h limitation: 8mg

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cui Xulei

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative 48hrs morphine	Cumulate morphine consumption 48 hours after hepatectomy	Postoperative 48 hours
Secondary	Heart rate	The average value of the heart rate during the operation measured at 10 minutes interval	During the operation
Secondary	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
Secondary	Sevoflurane concentration	The average value of the sevoflurane concentration during the operation measured at 10 minutes interval	During the operation
Secondary	Intraoperative medication dose	Doses of fentanyl, ephedrine, atrophin, phylepherine and urapidil used during the operation	During the operation
Secondary	Fluid volumes	Fluid volumes including volumes of crystalloid, colloid, red blood cells, plasma, platelet, Urine and hemorrhage.	During the operation
Secondary	Awake and extubation time	Time from stop of sevoflurane use to patient awake and extubation.	At the end of the operation
Secondary	Postoperative morphine consumption	Cumulative morphine consumption at 2, 4, 12, 24 hours after hepatectomy	Postoperative 2, 4, 12, 24hours
Secondary	Operation time	Time from the start to the end of the operation	During the operation
Secondary	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
Secondary	Adverse effects	Adverse effects of morphine including nausea, vomiting, pruritus and respiratory depression, bowel movement and Foley catheter removal.	Postoperative 0-48 hours
Secondary	Rescue analgesia	Times of rescue analgesia	Postoperative 0-48hours
Secondary	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
Secondary	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
Secondary	Length of hospital stay	Number of in-hospital days from admission to discharge	Two weeks after hospital discharge
Secondary	Chronic recovery data	Chronic recovery data including incidence of pain, numbness, hypoesthesia and sleep disorder	Postoperative 3 months
Secondary	Chronic pain characteristics	Incidence of difference types of pain including throbbing, aching, pricking and stabbing.	Postoperative 3 months
Secondary	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