Hepatectomy, Pain Management, Paravertebral Block
Conditions
Brief summary
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.
Interventions
Morphine given as intravenous patient-controlled analgesia bolus: 2mg, lock time: 5min, 1h limitation: 8mg
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).
Inject 25 ml 0.9% saline in the T8 paravertebral space followed with catheter insertion and continuous 0.9% ropivacaine infusion(infusion rate: 0.125ml/kg/pulse,1pulse/h).
Sponsors
Cui Xulei
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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 * Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the postoperative recovery quality on postoperative day 7 | at the 7th 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The pain scores determined by the numeric rating scale (NRS, 0-10) | At 8, 24,48 hours after the surgery | 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 |
| cumulated morphine consumption | At 8, 24,48 hours after the surgery | — |
| the postoperative recovery quality on postoperative day 3 | at the 3th postoperative day | QoR-15 questionnaire 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). |
| time to out-of bed activity/ambutation | Up to 2 weeks | — |
| post operative length of stay | Up to 2 weeks | — |
| time to resumption of bowel movement | Up to 2 weeks after surgery | — |
Countries
China
Outcome results
None listed