CTPVB for Hepatectomy

NCT03990922 — Not applicable, Completed, 76 participants, Cui Xulei

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Continuous Thoracic Paravertebral Block for Open Hepatectomy

Registry	NCT03990922
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, supportive care
Enrollment	76 (Actual)
Sponsor	Cui Xulei (Other)
Conditions	Pain Management, Paravertebral Block, Hepatectomy
Interventions	Continuous Paravertebral block with ropivacaine, Continuous Paravertebral "block" with saline, Patient-controlled analgesia with morphine (Procedure, drug)
Dates	start 2019-06-20, primary completion 2019-11-09, completion 2019-11-17, first posted 2019-06-19, last updated 2020-01-02
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
CTPVB with ropivocaine	Experimental	Procedure: Continuous Paravertebral block with ropivacaine; Drug: Patient-controlled analgesia with morphine	Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with morphine
CTPVB with saline	Placebo comparator	Procedure: Continuous Paravertebral "block" with saline; Drug: Patient-controlled analgesia with morphine	Continuous Paravertebral block with saline and Patient-controlled analgesia with morphine

Continuous Paravertebral block with ropivacaine (Procedure): 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).
Continuous Paravertebral "block" with saline (Procedure): 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).
Patient-controlled analgesia with morphine (Drug): Morphine given as intravenous patient-controlled analgesia bolus: 2mg, lock time: 5min, 1h limitation: 8mg

+Outcome measures

Primary outcomes

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 outcomes

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).
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]
time to resumption of bowel movement [Up to 2 weeks after surgery]
time to out-of bed activity/ambutation [Up to 2 weeks]
post operative length of stay [Up to 2 weeks]

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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)

+Locations (1)

Facility	City	Country	Status
Peking Union Medical College Hospital	Beijing	China

+Investigators

xulei cui, MD, Principal investigator, Peking Union Medical College Hospital

My Notes

Public

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