NCT03844477

Brief Summary

This prospective, randomized ,control study aims to compare the analgesic effect,quality of recovery, length of hospital stay ,et al. between single-injection QLB(quadratus lumborum block)+general anesthesia (GA) and general anesthesia (GA) alone in patients undergoing laparoscopic adrenalectomy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

February 15, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

February 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
Last Updated

September 4, 2019

Status Verified

September 1, 2019

Enrollment Period

2 months

First QC Date

February 15, 2019

Last Update Submit

September 2, 2019

Conditions

Pain ManagementNerve BlockLaparoscopic Adrenalectomy

Outcome Measures

Primary Outcomes (1)

  • pain numeric rating scale (NRS, 0-10)pain score at activity at 12 hours after surgery

    At 12hours after the surgery

Secondary Outcomes (7)

  • The pain scores at rest determined by the numeric rating scale (NRS, 0-10)

    At 2,4, 8, 12,24 ,48,72hours after the surgery

  • incidence of postoperative nausea and vomiting (PONV)

    within 24 postoperative hours

  • ambulation time

    within5 days after surgery

  • time of restart anal exhaust

    within 5 days after surgery

  • Postoperative length of hospital stay

    up to2 weeks after surgery

  • +2 more secondary outcomes

Study Arms (2)

single-injection QLB(quadratus lumborum block)

EXPERIMENTAL

Single-injection of QLB with local anesthetic is given preoperatively

Procedure: single-injection QLB(quadratus lumborum block)

Placebo control

PLACEBO COMPARATOR

Single-injection of QLB with NS is given preoperatively

Procedure: Placebo control

Interventions

single-injection QLB(quadratus lumborum block)PROCEDURE

Inject 0.4ml/kg 0.5% ropivacaine between quadratus lumborum and psoas major without continuous local infusion Device: Ultrasound Scanner The curved (C1-5) probe of Ultrasound Scanner is used for scan Device: PAJUNK StimuLong Drug: single dose ropivacaine 0.4ml/kg 0.5% ropivacaine given immediately after the correct position of the tip of the needle has been verified.

single-injection QLB(quadratus lumborum block)
Placebo controlPROCEDURE

Inject 0.4ml/kg saline between quadratus lumborum and psoas major without continuous local infusion Device: Ultrasound Scanner The curved (C1-5) probe of Ultrasound Scanner is used for scan Device: PAJUNK StimuLong Drug: single dose 0.4ml/kg 0.9% NS. given immediately after the correct position of the tip of the needle has been verified.

Placebo control

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 laparoscopic adrenalectomy
  • 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)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Xulei CUI, md

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 15, 2019

First Posted

February 18, 2019

Study Start

February 16, 2019

Primary Completion

May 1, 2019

Study Completion

May 15, 2019

Last Updated

September 4, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)