4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Modified Paramedic Sagittal vs. Transverse TMQLB

Modified Paramedic Sagittal vs. Transverse TMQLB

Study Description
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.

Condition or disease Intervention/treatment Phase
Nerve Block Procedure: transverse scan, in-plane, posterior-anterior TMQLB Procedure: paramedian sagittal scan, in-plane, caudal-cranial TMQLB Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Randomized Prospective Study to Evaluate Cranial Dermatomal Spread of Modified Paramedic Sagittal Versus Transverse Approach TMQLB for Adrenal Surgery
Actual Study Start Date : September 15, 2018
Actual Primary Completion Date : February 14, 2019
Actual Study Completion Date : February 17, 2019
Arms and Interventions
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.
Outcome Measures
Primary Outcome Measures :
  1. Cephalic sensory dermatomal spread [ Time Frame: 20 minutes after block performance ]

Secondary Outcome Measures :
  1. Time to performance of procedure [ Time Frame: Duration of procedure ]
  2. Total sensory dermatomal spread [ Time Frame: 20 minutes after block performance ]
  3. Incidence of complication [ Time Frame: Within 48hours after surgery ]
  4. Caudal sensory dermatomal spread [ Time Frame: 20 minutes after block performance ]
  5. cumulative rate of rescue analgesics usage [ Time Frame: At 0,2,4,8,12,24,48 hours after surgery ]
  6. NRS pain scores [ Time Frame: At 0,2,4,8,12,24,48hours after surgery ]
    patients will evaluate their pain intensity with the numerical rating scale (NRS), where 0 indicates no pain, and 10 indicates the most severe pain.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Locations
Layout table for location information
China
Peking Union Medical College Hospital
Beijing, China
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Layout table for investigator information
Principal Investigator: Xulei CUI Peking Union Medical College Hospital
Tracking Information
First Submitted Date  ICMJE December 9, 2018
First Posted Date  ICMJE December 11, 2018
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE September 15, 2018
Actual Primary Completion Date February 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2018) 		Cephalic sensory dermatomal spread [ Time Frame: 20 minutes after block performance ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2018)
  • Time to performance of procedure [ Time Frame: Duration of procedure ]
  • Total sensory dermatomal spread [ Time Frame: 20 minutes after block performance ]
  • Incidence of complication [ Time Frame: Within 48hours after surgery ]
  • Caudal sensory dermatomal spread [ Time Frame: 20 minutes after block performance ]
  • cumulative rate of rescue analgesics usage [ Time Frame: At 0,2,4,8,12,24,48 hours after surgery ]
  • NRS pain scores [ Time Frame: At 0,2,4,8,12,24,48hours after surgery ]
    patients will evaluate their pain intensity with the numerical rating scale (NRS), where 0 indicates no pain, and 10 indicates the most severe pain.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2018)
  • Time to performance of procedure [ Time Frame: Duration of procedure ]
  • Total sensory dermatomal spread [ Time Frame: 20 minutes after block performance ]
  • Incidence of complication [ Time Frame: Within 48hrs after surgery ]
  • Caudal sensory dermatomal spread [ Time Frame: 20 minutes after block performance ]
  • cumulative rate of rescue analgesics usage [ Time Frame: At 0,2,4,8,12,24,48hrs after surgery ]
  • NRS pain scores [ Time Frame: At 0,2,4,8,12,24,48hrs after surgery ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modified Paramedic Sagittal vs. Transverse TMQLB
Official Title  ICMJE Randomized Prospective Study to Evaluate Cranial Dermatomal Spread of Modified Paramedic Sagittal Versus Transverse Approach TMQLB for Adrenal Surgery
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Nerve Block
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: transverse scan, in-plane, posterior-anterior TMQLB
  • 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.
    Intervention: Procedure: paramedian sagittal scan, in-plane, caudal-cranial TMQLB
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2018) 		50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 17, 2019
Actual Primary Completion Date February 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03771742
Other Study ID Numbers  ICMJE cuixule6
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cui Xulei, Peking Union Medical College Hospital
Study Sponsor  ICMJE Peking Union Medical College Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xulei CUI Peking Union Medical College Hospital
PRS Account Peking Union Medical College Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯