NCT02841982

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. between single-injection QLB(quadratus lumborum block)+ intravenous patient-controlled analgesia (IPCA) and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing laparoscopic renal surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 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

July 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

2.3 years

First QC Date

July 20, 2016

Last Update Submit

May 16, 2019

Conditions

Laparoscopic Renal SurgeryPain ManagementNerve 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 after the surgery

  • nausea and vomiting score

    within 24 hours after the surgery

  • pruritus score

    within 24hour after the surgery

  • ambulation time

    within the 7 days after surgery

  • time of recovery of bowl movement

    within the 5 days after surgery

  • +3 more secondary outcomes

Study Arms (2)

single-injection QLB(quadratus lumborum block)

EXPERIMENTAL

Single-injection of QLB is given preoperatively + postoperative IPCA(intravenous patient controlled analgesia)

Procedure: single-injection QLB(quadratus lumborum block)Device: Philip CX50 Ultrasound ScannerDevice: PAJUNK StimuLongDrug: single dose ropivacaineDrug: Morphine given as IPCA(intravenous patient controlled analgesia)

IPCA

ACTIVE COMPARATOR

postoperative IPCA is given alone

Drug: Morphine given as IPCA(intravenous patient controlled analgesia)

Interventions

single-injection QLB(quadratus lumborum block)PROCEDURE

Inject local anesthetics in between quadratus lumborum and psoas major without continuous local infusion

single-injection QLB(quadratus lumborum block)
Philip CX50 Ultrasound ScannerDEVICE

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

single-injection QLB(quadratus lumborum block)
PAJUNK StimuLongDEVICE
single-injection QLB(quadratus lumborum block)
single dose ropivacaineDRUG

* 0.6ml/kg 0.5% ropivacaine with 1:200,000 adrenaline. * given immediately after the correct position of the tip of the needle has been verified.

single-injection QLB(quadratus lumborum block)
Morphine given as IPCA(intravenous patient controlled analgesia)DRUG

bolus: 1.5\~2mg, lock time: 10min, 1h limitation: 6\~8mg

IPCAsingle-injection QLB(quadratus lumborum block)

Eligibility Criteria

Age17 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70 yrs
  • American Society of Anesthesiologists physical statusⅠ-Ⅲ
  • Undergo laparoscopic nephrectomy
  • 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

Ropivacaine

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
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

July 20, 2016

First Posted

July 22, 2016

Study Start

August 1, 2016

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

May 20, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)