Programmed Intermittent Bolus Infusion of Thoracic Paravertebral Block for Hepatectomy
- Conditions
- Paravertebral BlockHepatectomyPostoperative RecoveryAnalgesia
- Interventions
- Procedure: Paravertebral block-salineProcedure: Paravertebral block-ropivacaineDrug: patient controlled analgesia with morphine
- Registration Number
- NCT04304274
- Lead Sponsor
- Cui Xulei
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
- Age 18-70 yrs
- American Society of Anesthesiologists physical statusⅠ-Ⅲ
- Undergo hepatectomy with J-shape subcostal incision
- Informed consent
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PTPVB-saline patient controlled analgesia with morphine Programmed intermittent bolus infusion of a thoracic paravertebral block with saline and patient-controlled analgesia with morphine PTPVB-ropivacaine patient controlled analgesia with morphine Programmed intermittent bolus infusion of a thoracic paravertebral block with ropivacaine and patient-controlled analgesia with morphine PTPVB-saline Paravertebral block-saline Programmed intermittent bolus infusion of a thoracic paravertebral block with saline and patient-controlled analgesia with morphine PTPVB-ropivacaine Paravertebral block-ropivacaine Programmed intermittent bolus infusion of a thoracic paravertebral block with ropivacaine and patient-controlled analgesia with morphine
- Primary Outcome Measures
Name Time Method Postoperative 48hrs morphine Postoperative 48 hours Cumulate morphine consumption 48 hours after hepatectomy
- Secondary Outcome Measures
Name Time Method Sevoflurane concentration During the operation The average value of the sevoflurane concentration during the operation measured at 10 minutes interval
Operation time During the operation Time from the start to the end of the operation
The pain scores(at rest and with cough) determined by the numeric rating scale Postoperative 0, 2, 4, 12, 24 and 48 hours 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 recovery indices Postoperative 48 hours 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.
Intraoperative medication dose During the operation Doses of fentanyl, ephedrine, atrophin, phylepherine and urapidil used during the operation
Postoperative morphine consumption Postoperative 2, 4, 12, 24hours Cumulative morphine consumption at 2, 4, 12, 24 hours after hepatectomy
Mean blood pressure During the operation The average value of the mean blood pressure (=1/3 systolic pressure + 2/3 diastolic pressure) during the operation measured at 10 minutes interval.
Fluid volumes During the operation Fluid volumes including volumes of crystalloid, colloid, red blood cells, plasma, platelet, Urine and hemorrhage.
Rescue analgesia Postoperative 0-48hours Times of rescue analgesia
Awake and extubation time At the end of the operation Time from stop of sevoflurane use to patient awake and extubation.
Adverse effects Postoperative 0-48 hours Adverse effects of morphine including nausea, vomiting, pruritus and respiratory depression, bowel movement and Foley catheter removal.
Chronic recovery data Postoperative 3 months Chronic recovery data including incidence of pain, numbness, hypoesthesia and sleep disorder
Chronic pain characteristics Postoperative 3 months Incidence of difference types of pain including throbbing, aching, pricking and stabbing.
Heart rate During the operation The average value of the heart rate during the operation measured at 10 minutes interval
Length of hospital stay Two weeks after hospital discharge Number of in-hospital days from admission to discharge
Satisfaction indices Postoperative 48 hours 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.
Chronic pain NRS score Postoperative 3 months 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.
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, China