Continuous Paravertebral Block on Postoperative Quality of Recovery After Hepatectomy

Nerve Block Clinical Trial

Official title:

Effect of Continuous Paravertebral Block on Postoperative Quality of Recovery After Hepatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03777644
• Other study ID #: cuixulei7
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: May 19, 2019

Study information

• Verified date: June 2020
• 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: May 19, 2019
• Est. primary completion date: May 12, 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

• Nerve Block

Intervention

Procedure:
• Continuous Paravertebral block with ropivacaine
Inject local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion. Device: Philip CX50 Ultrasound Scanner The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning Device: PAJUNK Contiplex S Catheter Drug: single dose ropivacaine 0.5%ropivacaine with 1:200,000 adrenaline, 25ml in total given immediately after the correct position of the tip of the needle has been confirmed Drug: continuously infusion of ropivacaine 0.2% ropivacaine, infusion rate: 0.125ml/kg/pulse,1pulse/h given through the catheter inserted in the T8 paravertebral space following the single dose Drug: Morphine given as IPCA bolus: 2mg, lock time: 5min, 1h limitation: 8mg
• Continuous Paravertebral Block with Saline
Inject local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion. Device: Philip CX50 Ultrasound Scanner The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning Device: PAJUNK Contiplex S Catheter Drug: single dose saline,25ml in total given immediately after the correct position of the tip of the needle has been confirmed Drug: continuously infusion of saline 0.9% saline, infusion rate: 0.125ml/kg/pulse,1pulse/h given through the catheter inserted in the T8 paravertebral space following the single dose

Drug:
• Patient-controlled analgesia with morphine
Drug: Morphine given as IPCA 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 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	post operative length of stay		Up to 2 weeks
Secondary	time to out-of bed activity/ambutation		Up to 2 weeks
Secondary	time to resumption of bowel movement		Up to 2 weeks after surgery
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