NCT05001802

Brief Summary

Our objective is to investigate the extent of cranial dermatomal spread of transmuscular quadratus lumborum block(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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

May 19, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

August 20, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

May 19, 2021

Last Update Submit

November 15, 2021

Conditions

Nerve Block

Outcome Measures

Primary Outcomes (1)

  • Cephalic sensory dermatomal spread

    The pinprick method at the midclavicular line was used to assess the extent of the dermatomal blockade, 20 minutes following the completion of the procedure by a person who was blinded to group allocation. The most cephalic dermatomal level that show a decreased pinprick sensation is recorded.A block failure was defined as the absence of any demonstrable sensory block 20 minutes after performance of the block.

    20 minutes after block performance]

Secondary Outcomes (5)

  • Time to performance of procedure

    Duration of procedure

  • Total sensory dermatomal spread

    20 minutes after block performance

  • Incidence of complication

    Within 48 hours after surgery

  • Caudal sensory dermatomal spread

    20 minutes after block performance

  • rescue analgesics usage

    At 0,12,24,48 hours after surgery

Study Arms (2)

transverse quadratus lumborum block

ACTIVE COMPARATOR

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

Procedure: transverse scan, in-plane, posterior- anterior quadratus lumborum block

longitudinal quadratus lumborum block

EXPERIMENTAL

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

Procedure: paramedian sagittal longitudinal scan, in-plane, caudal-cranial quadratus lumborum block

Interventions

transverse scan, in-plane, posterior- anterior quadratus lumborum blockPROCEDURE

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

Also known as: drug:ropivacaine
transverse quadratus lumborum block
paramedian sagittal longitudinal scan, in-plane, caudal-cranial quadratus lumborum blockPROCEDURE

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

Also known as: drug:ropivacaine
longitudinal quadratus lumborum block

Eligibility Criteria

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

You may qualify if:

  • ≥Age 18yrs
  • American Society of Anesthesiologists physical status I-II
  • 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 (2)

Peking Union Medical College Hospital

Beijing, China

NOT YET RECRUITING

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Central Study Contacts

Xulei MD Cui

CONTACT

+8613717739381cuixulei10685@pumch.cn

Study Design

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

Study Record Dates

First Submitted

May 19, 2021

First Posted

August 12, 2021

Study Start

August 20, 2021

Primary Completion

November 16, 2021

Study Completion

December 1, 2021

Last Updated

November 17, 2021

Record last verified: 2021-11

Locations

CN(2)