Modified Paramedic Sagittal vs. Transverse TMQLB

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

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.

Study Overview

• Status: Completed
• Conditions: Nerve Block
• Intervention / Treatment: Procedure: transverse scan, in-plane, posterior-anterior TMQLB; Procedure: paramedian sagittal scan, in-plane, caudal-cranial TMQLB

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-70 yrs
• American Society of Anesthesiologists physical statusⅠ-Ⅲ
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: transverse TMQLB; 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; 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.
Experimental: paramedian sagittal TMQLB; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cephalic sensory dermatomal spread	20 minutes after block performance

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Xulei Cui, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2018
• Primary Completion (Actual): February 14, 2019
• Study Completion (Actual): February 17, 2019

Study Registration Dates

• First Submitted: December 9, 2018
• First Submitted That Met QC Criteria: December 9, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: cuixule6

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No