NCT03771742

Brief Summary

The classical transmuscular qudratus lumborum block(TMQLB) described by Borglum aims to provide lower thoracic paravertebral space(PVS) and sympathetic blockade by injecting local anesthetics between QL and PM muscle at the L3-L4 vertebral level using a transverse scan, posterior-anterior, in-plane approach. Recently, a paramedian sagittal oblique(TMQLB) approach has been introduced to facilitate cranial spread by injecting the local in a caudal to cranial direction. Currently, there are no data comparing the two techniques mentioned above with regards to extent of spread for PVS. Our objective is to investigate the extent of cranial dermatomal spread of TMQLB when equal dosage(ml/kg) of local anesthetic are injected with the transverse versus an modified paramedian sagittal approach for patients undergoing laparoscopic adrenalectomy. In addition, the investigators wish to compare the performance time, caudal dermatomal spread of TMQLB and postoperative analgesia effect.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2019

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

5 months

First QC Date

December 9, 2018

Last Update Submit

April 15, 2019

Conditions

Nerve Block

Outcome Measures

Primary Outcomes (1)

  • Cephalic sensory dermatomal spread

    20 minutes after block performance

Secondary Outcomes (6)

  • Time to performance of procedure

    Duration of procedure

  • Total sensory dermatomal spread

    20 minutes after block performance

  • Incidence of complication

    Within 48hours after surgery

  • Caudal sensory dermatomal spread

    20 minutes after block performance

  • cumulative rate of rescue analgesics usage

    At 0,2,4,8,12,24,48 hours after surgery

  • +1 more secondary outcomes

Study Arms (2)

transverse TMQLB

ACTIVE COMPARATOR

Patients in this group will receive the transmuscular quadratus lumborum block before surgery using the transverse scan, in-plain, posterior to anterior approach. 0.6ml 0.375% ropivocaine was injected when the correct needle location is confirmed.

Procedure: transverse scan, in-plane, posterior-anterior TMQLB

paramedian sagittal TMQLB

EXPERIMENTAL

Patients in this group will receive the transmuscular quadratus lumborum block before surgery using the para-sagittal scan, in-plain, caudal to cephalic approach.0.6ml 0.375% ropivocaine was injected when the correct needle location is confirmed.

Procedure: paramedian sagittal scan, in-plane, caudal-cranial TMQLB

Interventions

transverse scan, in-plane, posterior-anterior TMQLBPROCEDURE

The patients will receive the transmuscular quadratus lumborum block(TMQLB) before surgery using the transverse scan, in-plain, posterior to anterior approach. 0.6ml/kg 0.375% ropivocaine is injected when the correct needle location is confirmed.

transverse TMQLB
paramedian sagittal scan, in-plane, caudal-cranial TMQLBPROCEDURE

The patients will receive the transmuscular quadratus lumborum block(TMQLB) before surgery using the paramedic sagittal scan, in-plain, caudal-cephalic approach.0.6ml/kg 0.375% ropivocaine is injected when the correct needle location is confirmed.

paramedian sagittal TMQLB

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
  • Able to cooperate with study process

You may not qualify if:

  • Allergy to local anesthetic and other medications used in the study
  • Patient refusal or lack of informed consent
  • Coexisting hematological disorder or with deranged coagulation parameters
  • Pre-existing major organ dysfunction such as hepatic and renal failure
  • History of previous renal surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

Study Officials

  • Xulei CUI

    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
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

December 9, 2018

First Posted

December 11, 2018

Study Start

September 15, 2018

Primary Completion

February 14, 2019

Study Completion

February 17, 2019

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations

CN(1)