NCT02817321

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

January 8, 2019

Status Verified

January 1, 2019

Enrollment Period

12 months

First QC Date

June 22, 2016

Last Update Submit

January 6, 2019

Conditions

HepatectomyAnalgesiaNerve Block

Outcome Measures

Primary Outcomes (1)

  • cumulative morphine consumption

    within 48 postoperative hours

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Single-injection TPVB +continuous TPVB

EXPERIMENTAL

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

Procedure: single-injection TPVB + continuous TPVBDevice: Philip CX50 Ultrasound ScannerDevice: PAJUNK Contiplex S CatheterDrug: single dose ropivacaineDrug: continuously infusion of ropivacaineDrug: Morphine given as IPCA

IPCA

ACTIVE COMPARATOR

postoperative IPCA is given alone

Drug: Morphine given as IPCA

Interventions

single-injection TPVB + continuous TPVBPROCEDURE

Inject local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion.

Single-injection TPVB +continuous TPVB
Philip CX50 Ultrasound ScannerDEVICE

The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning

Single-injection TPVB +continuous TPVB
PAJUNK Contiplex S CatheterDEVICE
Single-injection TPVB +continuous TPVB
single dose ropivacaineDRUG

* 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

Single-injection TPVB +continuous TPVB
continuously infusion of ropivacaineDRUG

* 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

Single-injection TPVB +continuous TPVB
Morphine given as IPCADRUG

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

IPCASingle-injection TPVB +continuous TPVB

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70 yrs
  • American Society of Anesthesiologists physical statusⅠ-Ⅲ
  • Undergo hepatectomy with J-shape subcostal incision
  • Informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xulei CUI

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Agnosia

Interventions

Ropivacaineisopropyl cyanoacrylate

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Yuguang Huang, MD.

    Peking Union Medical College Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 29, 2016

Study Start

November 1, 2016

Primary Completion

October 31, 2017

Study Completion

November 1, 2018

Last Updated

January 8, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)