Continuous Paravertebral Block on Postoperative Quality of Recovery After Hepatectomy
Effect of Continuous Paravertebral Block on Postoperative Quality of Recovery After Hepatectomy
Moderate to severe postoperative pain often influence patients quality of recovery after hepatectomy. Systemic opioids given with patient-controlled analgesia has been used after hepatectomy in many medical center, but the analgesic effect can be limited and undesirable side effects may bring about negative effects on patients recovery. Regional block has been proved to improve patients postoperative recovery in many kinds of surgeries.
The investigators therefore designed a prospective, randomized, subject and assessor blinded, parallel-group, placebo controlled study to test the hypothesis that continuous right thoracic paravertebral block increase patients quality of recovery score on the 7th postoperative day after hepatectomy in patients receiving i.v. patient-controlled analgesia (PCA) with morphine.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Beijing, China
- Peking Union Medical College Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: TPVB + PCA
Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with morphine
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Inject local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion. Device: Philip CX50 Ultrasound Scanner The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning Device: PAJUNK Contiplex S Catheter Drug: single dose ropivacaine 0.5%ropivacaine with 1:200,000 adrenaline, 25ml in total given immediately after the correct position of the tip of the needle has been confirmed Drug: continuously infusion of ropivacaine 0.2% ropivacaine, infusion rate: 0.125ml/kg/pulse,1pulse/h given through the catheter inserted in the T8 paravertebral space following the single dose Drug: Morphine given as IPCA bolus: 2mg, lock time: 5min, 1h limitation: 8mg
Drug: Morphine given as IPCA bolus: 2mg, lock time: 5min, 1h limitation: 8mg
|
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Placebo Comparator: placebo TPVB + PCA
Continuous Paravertebral Block with Saline and Patient-controlled analgesia with morphine
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Drug: Morphine given as IPCA bolus: 2mg, lock time: 5min, 1h limitation: 8mg
Inject local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion. Device: Philip CX50 Ultrasound Scanner The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning Device: PAJUNK Contiplex S Catheter Drug: single dose saline,25ml in total given immediately after the correct position of the tip of the needle has been confirmed Drug: continuously infusion of saline 0.9% saline, infusion rate: 0.125ml/kg/pulse,1pulse/h given through the catheter inserted in the T8 paravertebral space following the single dose |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the postoperative recovery quality on postoperative day 7
Time Frame: at the 7th postoperative day
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The postoperative recovery quality is evaluated with QoR-15 questionnaire.
The QoR-15 is a 15-item questionnaire intended to measure QoR after anesthesia and surgery.
It comprises five subscales: pain (2 items), physical comfort (5 items), physical independence (2 items), psychological support (2 items), and emotional state (4 items) [2 Stark PA, Myles PS, Burke JA.
Development and psychometric evaluation of a postoperative quality of recovery score: the QoR- 15.
Anesthesiology.
2013;118(6):1332.].
Each item is scored from 0 to 10, and the possible total score ranges from 0(extremely poor quality of recovery) to 150 (excellent quality of re covery).
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at the 7th postoperative day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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cumulated morphine consumption
Time Frame: At 8, 24,48 hours after the surgery
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At 8, 24,48 hours after the surgery
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time to resumption of bowel movement
Time Frame: Up to 2 weeks after surgery
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Up to 2 weeks after surgery
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time to out-of bed activity/ambutation
Time Frame: Up to 2 weeks
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Up to 2 weeks
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|
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post operative length of stay
Time Frame: Up to 2 weeks
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Up to 2 weeks
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The pain scores determined by the numeric rating scale (NRS, 0-10)
Time Frame: At 8, 24,48 hours after the surgery
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The patients evaluated their pain severity with thenumeric rating scale (NRS, 0-10),where 0 indicates no pain, and 10 indicates the most severe pain.
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At 8, 24,48 hours after the surgery
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the postoperative recovery quality on postoperative day 3: QoR-15 questionnaire
Time Frame: at the 3th postoperative day
|
The postoperative recovery quality is evaluated with QoR-15 questionnaire.
The QoR-15 is a 15-item questionnaire intended to measure QoR after anesthesia and surgery.
It comprises five subscales: pain (2 items), physical comfort (5 items), physical independence (2 items), psychological support (2 items), and emotional state (4 items) [2 Stark PA, Myles PS, Burke JA.
Development and psychometric evaluation of a postoperative quality of recovery score: the QoR- 15.
Anesthesiology.
2013;118(6):1332.].
Each item is scored from 0 to 10, and the possible total score ranges from 0(extremely poor quality of recovery) to 150 (excellent quality of re covery).
|
at the 3th postoperative day
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- cuixulei7
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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