Modified Paramedic Sagittal vs. Transverse TMQLB

Nerve Block Clinical Trial

Official title:

Randomized Prospective Study to Evaluate Cranial Dermatomal Spread of Modified Paramedic Sagittal Versus Transverse Approach TMQLB for Adrenal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03771742
• Other study ID #: cuixule6
• Status: Completed
• Phase: N/A
• Start date: September 15, 2018
• Est. completion date: February 17, 2019

Study information

• Verified date: April 2019
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 17, 2019
• Est. primary completion date: February 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 18-70 yrs

• American Society of Anesthesiologists physical status?-?

• Undergo laparoscopic adrenalectomy

• Informed consent

• Able to cooperate with study process

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Nerve Block

Intervention

Procedure:
• transverse scan, in-plane, posterior-anterior TMQLB
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.
• paramedian sagittal scan, in-plane, caudal-cranial TMQLB
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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cephalic sensory dermatomal spread		20 minutes after block performance
Secondary	Time to performance of procedure		Duration of procedure
Secondary	Total sensory dermatomal spread		20 minutes after block performance
Secondary	Incidence of complication		Within 48hours after surgery
Secondary	Caudal sensory dermatomal spread		20 minutes after block performance
Secondary	cumulative rate of rescue analgesics usage		At 0,2,4,8,12,24,48 hours after surgery
Secondary	NRS pain scores	patients will evaluate their pain intensity with the numerical rating scale (NRS), where 0 indicates no pain, and 10 indicates the most severe pain.	At 0,2,4,8,12,24,48hours after surgery