CTPVB for Hepatectomy

Pain Management Clinical Trial

Official title:

Continuous Thoracic Paravertebral Block for Open Hepatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03990922
• Other study ID #: PVB_H
• Status: Completed
• Phase: N/A
• Start date: June 20, 2019
• Est. completion date: November 17, 2019

Study information

• Verified date: December 2019
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 17, 2019
• Est. primary completion date: November 9, 2019
• 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)

Related Conditions & MeSH terms

• Hepatectomy
• Pain Management
• Paravertebral Block

Intervention

Procedure:
• Continuous Paravertebral block with ropivacaine
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
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).

Drug:
• Patient-controlled analgesia with morphine
Morphine given as intravenous patient-controlled analgesia bolus: 2mg, lock time: 5min, 1h limitation: 8mg

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cui Xulei

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the postoperative recovery quality on postoperative day 7	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 7th postoperative day
Secondary	the postoperative recovery quality on postoperative day 3	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).	at the 3th postoperative day
Secondary	The pain scores determined by the numeric rating scale (NRS, 0-10)	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	At 8, 24,48 hours after the surgery
Secondary	cumulated morphine consumption		At 8, 24,48 hours after the surgery
Secondary	time to resumption of bowel movement		Up to 2 weeks after surgery
Secondary	time to out-of bed activity/ambutation		Up to 2 weeks
Secondary	post operative length of stay		Up to 2 weeks