Analgesia Clinical Trial
NCT number | NCT02817321 |
Other study ID # | cuixulei2 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | November 2018 |
Verified date | January 2019 |
Source | Peking Union Medical College Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This prospective, randomized study,control study aims to compare the analgesic effect,opioids consumption,quality of recovery,length of hospital stay and incidence of chronic pain,et al. single-injection TPVB +continuous(pulsatile infusion) TPVB and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing hepatectomy with right J-shape subcostal incision.
Status | Completed |
Enrollment | 76 |
Est. completion date | November 2018 |
Est. primary completion date | October 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Age 18-70 yrs - American Society of Anesthesiologists physical status?-? - 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) |
Country | Name | City | State |
---|---|---|---|
China | Xulei CUI | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Cui Xulei |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | cumulative morphine consumption | within 48 postoperative hours | ||
Secondary | The pain scores determined by the numeric rating scale (NRS, 0-10) | At 0, 2,4, 8, 12, 24 ,48,72hours and 7day after the surgery | ||
Secondary | nausea and vomiting score | At 0, 2,4, 8, 12, 24 and 48hours after the surgery | ||
Secondary | pruritus score | At 0, 2,4, 8, 12, 24 and 48hours after the surgery | ||
Secondary | ambulation time | within the 7 days after surgery | ||
Secondary | time of recovery of bowl movement | within the 7 days after surgery | ||
Secondary | Postoperative hospital length of stay | Up to 4 weeks | ||
Secondary | patient satisfaction with anesthesia | use the Chinese version Bauer questionnaire to assess the patient satisfaction with anesthesia | 48 hours after surgery | |
Secondary | data collection of chronic pain | Patients undergo a telephone interview with a questionnaire at 3, 6 and 12 months after surgery, the incidence and severity of chronic pain is recorded. | at 3,6,12 months after surgery |
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