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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Postoperative 48hrs morphine
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
PTPVB-ropivacaine
Programmed intermittent bolus infusion of a thoracic paravertebral block with ropivacaine and patient-controlled analgesia with morphine
Intervention: Paravertebral block-ropivacaine (Procedure)
PTPVB-ropivacaine
Programmed intermittent bolus infusion of a thoracic paravertebral block with ropivacaine and patient-controlled analgesia with morphine
Intervention: patient controlled analgesia with morphine (Drug)
PTPVB-saline
Programmed intermittent bolus infusion of a thoracic paravertebral block with saline and patient-controlled analgesia with morphine
Intervention: Paravertebral block-saline (Procedure)
PTPVB-saline
Programmed intermittent bolus infusion of a thoracic paravertebral block with saline and patient-controlled analgesia with morphine
Intervention: patient controlled analgesia with morphine (Drug)
Outcomes
Primary Outcomes
Postoperative 48hrs morphine
Time Frame: Postoperative 48 hours
Cumulate morphine consumption 48 hours after hepatectomy
Secondary Outcomes
- Sevoflurane concentration(During the operation)
- Operation time(During 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)
- Postoperative recovery indices(Postoperative 48 hours)
- Intraoperative medication dose(During the operation)
- Postoperative morphine consumption(Postoperative 2, 4, 12, 24hours)
- Mean blood pressure(During the operation)
- Fluid volumes(During the operation)
- Rescue analgesia(Postoperative 0-48hours)
- Awake and extubation time(At the end of the operation)
- Adverse effects(Postoperative 0-48 hours)
- Chronic recovery data(Postoperative 3 months)
- Chronic pain characteristics(Postoperative 3 months)
- Heart rate(During the operation)
- Length of hospital stay(Two weeks after hospital discharge)
- Satisfaction indices(Postoperative 48 hours)
- Chronic pain NRS score(Postoperative 3 months)
Investigators
Cui Xulei
Professor
Peking Union Medical College Hospital