CTPVB for Hepatectomy

Sponsor

Cui Xulei (Other)

Overall Status

Completed

CT.gov ID

NCT03990922

Collaborator

(none)

Enrollment

Location

Arms

4.9

Actual Duration (Months)

15.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Management Paravertebral Block Hepatectomy	Procedure: Continuous Paravertebral block with ropivacaine Procedure: Continuous Paravertebral "block" with saline Drug: Patient-controlled analgesia with morphine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Continuous Thoracic Paravertebral Block for Open Hepatectomy

Actual Study Start Date :

Jun 20, 2019

Actual Primary Completion Date :

Nov 9, 2019

Actual Study Completion Date :

Nov 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CTPVB with ropivocaine Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with morphine	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). Drug: Patient-controlled analgesia with morphine Morphine given as intravenous patient-controlled analgesia bolus: 2mg, lock time: 5min, 1h limitation: 8mg
Placebo Comparator: CTPVB with saline Continuous Paravertebral block with saline and Patient-controlled analgesia with morphine	Procedure: 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

Arm

Intervention/Treatment

Experimental: CTPVB with ropivocaine

Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with morphine

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).

Drug: Patient-controlled analgesia with morphine

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

Placebo Comparator: CTPVB with saline

Continuous Paravertebral block with saline and Patient-controlled analgesia with morphine

Procedure: 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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing		China

Sponsors and Collaborators

Cui Xulei

Investigators

Principal Investigator: xulei cui, MD, Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cui Xulei, attending physician, Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT03990922

Other Study ID Numbers:

PVB_H

First Posted:

Jun 19, 2019

Last Update Posted:

Jan 2, 2020

Last Verified:

Dec 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Morphine

Ropivacaine

Study Results

No Results Posted as of Jan 2, 2020