Clinical trial NCT04304274: Programmed Intermittent Bolus Infusion of Thoracic Paravertebral Block for Hepatectomy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paravertebral Block
Hepatectomy
Analgesia
Postoperative Recovery
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative 48hrs morphine
timeFrame: Postoperative 48 hours
Secondary outcomes:
measure: Heart rate
timeFrame: During the operation
measure: Mean blood pressure
timeFrame: During the operation
measure: Sevoflurane concentration
timeFrame: During the operation
measure: Intraoperative medication dose
timeFrame: During the operation
measure: Fluid volumes
timeFrame: During the operation
measure: Awake and extubation time
timeFrame: At the end of the operation
measure: Postoperative morphine consumption
timeFrame: Postoperative 2, 4, 12, 24hours
measure: Operation time
timeFrame: During the operation
measure: The pain scores(at rest and with cough) determined by the numeric rating scale
timeFrame: Postoperative 0, 2, 4, 12, 24 and 48 hours
measure: Adverse effects
timeFrame: Postoperative 0-48 hours
measure: Rescue analgesia
timeFrame: Postoperative 0-48hours
measure: Postoperative recovery indices
timeFrame: Postoperative 48 hours
measure: Satisfaction indices
timeFrame: Postoperative 48 hours
measure: Length of hospital stay
timeFrame: Two weeks after hospital discharge
measure: Chronic recovery data
timeFrame: Postoperative 3 months
measure: Chronic pain characteristics
timeFrame: Postoperative 3 months
measure: Chronic pain NRS score
timeFrame: Postoperative 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xulei Cui, MD
role: PRINCIPAL_INVESTIGATOR
References: