Effect of Continuous Paravertebral Block on Postoperative Quality of Recovery After Hepatectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- the postoperative recovery quality on postoperative day 7
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- 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
- •Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)
Arms & Interventions
TPVB + PCA
Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with morphine
Intervention: Patient-controlled analgesia with morphine (Drug)
TPVB + PCA
Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with morphine
Intervention: Continuous Paravertebral block with ropivacaine (Procedure)
placebo TPVB + PCA
Continuous Paravertebral Block with Saline and Patient-controlled analgesia with morphine
Intervention: Continuous Paravertebral Block with Saline (Procedure)
placebo TPVB + PCA
Continuous Paravertebral Block with Saline and Patient-controlled analgesia with morphine
Intervention: Patient-controlled analgesia with morphine (Drug)
Outcomes
Primary Outcomes
the postoperative recovery quality on postoperative day 7
Time Frame: 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 Outcomes
- post operative length of stay(Up to 2 weeks)
- time to out-of bed activity/ambutation(Up to 2 weeks)
- the postoperative recovery quality on postoperative day 3: QoR-15 questionnaire(at the 3th postoperative day)
- cumulated morphine consumption(At 8, 24,48 hours after the surgery)
- time to resumption of bowel movement(Up to 2 weeks after surgery)
- The pain scores determined by the numeric rating scale (NRS, 0-10)(At 8, 24,48 hours after the surgery)
Investigators
Cui Xulei
attending physician
Peking Union Medical College Hospital