Programmed Intermittent Bolus Infusion of Thoracic Paravertebral Block for Hepatectomy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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:
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:
|
| Placebo Comparator: PTPVB-saline Programmed intermittent bolus infusion of a thoracic paravertebral block with saline and patient-controlled analgesia with morphine |
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:
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:
|
Outcome Measures
Primary Outcome Measures
- Postoperative 48hrs morphine [Postoperative 48 hours]
Cumulate morphine consumption 48 hours after hepatectomy
Secondary Outcome Measures
- Heart rate [During the operation]
The average value of the heart rate during the operation measured at 10 minutes interval
- 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.
- Sevoflurane concentration [During the operation]
The average value of the sevoflurane concentration during the operation measured at 10 minutes interval
- Intraoperative medication dose [During the operation]
Doses of fentanyl, ephedrine, atrophin, phylepherine and urapidil used during the operation
- Fluid volumes [During the operation]
Fluid volumes including volumes of crystalloid, colloid, red blood cells, plasma, platelet, Urine and hemorrhage.
- Awake and extubation time [At the end of the operation]
Time from stop of sevoflurane use to patient awake and extubation.
- Postoperative morphine consumption [Postoperative 2, 4, 12, 24hours]
Cumulative morphine consumption at 2, 4, 12, 24 hours after hepatectomy
- 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.
- Adverse effects [Postoperative 0-48 hours]
Adverse effects of morphine including nausea, vomiting, pruritus and respiratory depression, bowel movement and Foley catheter removal.
- Rescue analgesia [Postoperative 0-48hours]
Times of rescue analgesia
- 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.
- 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.
- Length of hospital stay [Two weeks after hospital discharge]
Number of in-hospital days from admission to discharge
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18-70 yrs
-
American Society of Anesthesiologists physical statusⅠ-Ⅲ
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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
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Participating in the investigation of another experimental agent
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Unable to cooperate, eg. inability to properly describe postoperative pain to investigators
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking Union Medical College Hospital | Beijing | China |
Sponsors and Collaborators
- Cui Xulei
Investigators
- Principal Investigator: Xulei Cui, MD, Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PTPVB-H