Thoracic Paravertebral Block : Effect on Acute Pain and Chronic Pain of Hepatectomy With Right J-shape Subcostal Incision

Sponsor

Cui Xulei (Other)

Overall Status

Completed

CT.gov ID

NCT02817321

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatectomy Analgesia Nerve Block	Procedure: single-injection TPVB + continuous TPVB Device: Philip CX50 Ultrasound Scanner Device: PAJUNK Contiplex S Catheter Drug: single dose ropivacaine Drug: continuously infusion of ropivacaine Drug: Morphine given as IPCA	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Actual Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Oct 31, 2017

Actual Study Completion Date :

Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single-injection TPVB +continuous TPVB Single-injection of TPVB is given preoperatively followed with continuous infusion+ postoperative IPCA.	Procedure: single-injection TPVB + continuous TPVB 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 2mg/kg ropivacaine in saline 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, pulse dosadge: 0.125ml/kg/pulse, 1pulse/h at a rate of 6ml/minutes given through the catheter inserted in the T8 paravertebral space following the single dose Drug: Morphine given as IPCA bolus: 2mg, lock time: 10min, 1h limitation: 8mg
Active Comparator: IPCA postoperative IPCA is given alone	Drug: Morphine given as IPCA bolus: 2mg, lock time: 10min, 1h limitation: 8mg

Arm

Intervention/Treatment

Experimental: Single-injection TPVB +continuous TPVB

Single-injection of TPVB is given preoperatively followed with continuous infusion+ postoperative IPCA.

Procedure: single-injection TPVB + continuous TPVB

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

2mg/kg ropivacaine in saline 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, pulse dosadge: 0.125ml/kg/pulse, 1pulse/h at a rate of 6ml/minutes given through the catheter inserted in the T8 paravertebral space following the single dose

Drug: Morphine given as IPCA

bolus: 2mg, lock time: 10min, 1h limitation: 8mg

Active Comparator: IPCA

postoperative IPCA is given alone

Drug: Morphine given as IPCA

bolus: 2mg, lock time: 10min, 1h limitation: 8mg

Outcome Measures

Primary Outcome Measures

cumulative morphine consumption [within 48 postoperative hours]

Secondary Outcome Measures

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]
nausea and vomiting score [At 0, 2,4, 8, 12, 24 and 48hours after the surgery]
pruritus score [At 0, 2,4, 8, 12, 24 and 48hours after the surgery]
ambulation time [within the 7 days after surgery]
time of recovery of bowl movement [within the 7 days after surgery]
Postoperative hospital length of stay [Up to 4 weeks]
patient satisfaction with anesthesia [48 hours after surgery]
use the Chinese version Bauer questionnaire to assess the patient satisfaction with anesthesia
data collection of chronic pain [at 3,6,12 months after surgery]
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.

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	Xulei CUI	Beijing	Beijing	China	100730

Sponsors and Collaborators

Cui Xulei

Investigators

Study Chair: Yuguang Huang, 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:

NCT02817321

Other Study ID Numbers:

cuixulei2

First Posted:

Jun 29, 2016

Last Update Posted:

Jan 8, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Morphine

Ropivacaine

Study Results

No Results Posted as of Jan 8, 2019