Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Quadratus Lumborum Block : Effect on Acute Pain and Quality of Recovery After Laparoscopic Adrenalectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03844477
Recruitment Status : Terminated (We change the study protocal)
First Posted : February 18, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Cui Xulei, Peking Union Medical College Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This prospective, randomized ,control study aims to compare the analgesic effect,quality of recovery, length of hospital stay ,et al. between single-injection QLB(quadratus lumborum block)+general anesthesia (GA) and general anesthesia (GA) alone in patients undergoing laparoscopic adrenalectomy.

Condition or disease Intervention/treatment Phase
Pain Management Nerve Block Laparoscopic Adrenalectomy Procedure: single-injection QLB(quadratus lumborum block) Procedure: Placebo control Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Quadratus Lumborum Block : Effect on Acute Pain and Quality of Recovery After Laparoscopic Adrenalectomy
Actual Study Start Date : February 16, 2019
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : May 15, 2019
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: single-injection QLB(quadratus lumborum block)
Single-injection of QLB with local anesthetic is given preoperatively
 Procedure: single-injection QLB(quadratus lumborum block)

Inject 0.4ml/kg 0.5% ropivacaine between quadratus lumborum and psoas major without continuous local infusion

Device: Ultrasound Scanner The curved (C1-5) probe of Ultrasound Scanner is used for scan

Device: PAJUNK StimuLong Drug: single dose ropivacaine 0.4ml/kg 0.5% ropivacaine given immediately after the correct position of the tip of the needle has been verified.
Placebo Comparator: Placebo control
Single-injection of QLB with NS is given preoperatively
 Procedure: Placebo control

Inject 0.4ml/kg saline between quadratus lumborum and psoas major without continuous local infusion

Device: Ultrasound Scanner The curved (C1-5) probe of Ultrasound Scanner is used for scan

Device: PAJUNK StimuLong Drug: single dose 0.4ml/kg 0.9% NS. given immediately after the correct position of the tip of the needle has been verified.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. pain numeric rating scale (NRS, 0-10)pain score at activity at 12 hours after surgery [ Time Frame: At 12hours after the surgery ]

Secondary Outcome Measures :
  1. The pain scores at rest determined by the numeric rating scale (NRS, 0-10) [ Time Frame: At 2,4, 8, 12,24 ,48,72hours after the surgery ]
  2. incidence of postoperative nausea and vomiting (PONV) [ Time Frame: within 24 postoperative hours ]
  3. ambulation time [ Time Frame: within5 days after surgery ]
  4. time of restart anal exhaust [ Time Frame: within 5 days after surgery ]
  5. Postoperative length of hospital stay [ Time Frame: up to2 weeks after surgery ]
  6. patient's satisfaction with anesthesia and analgesia [ Time Frame: 48 hours after surgery ]
    use the Chinese version Bauer questionnaire to assess the patient satisfaction with anesthesia and analgesia

  7. The pain scores at activity determined by the numeric rating scale (NRS, 0-10) [ Time Frame: At 2,4, 8, 24 ,48,72hours after the surgery ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Exclusion Criteria:

  • A known allergy to the drugs being used
  • Coagulopathy, on anticoagulants
  • Analgesics intake, history of substance abuse
  • Participating in the investigation of another experimental agent
  • Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844477


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, md Peking Union Medical College Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Cui Xulei, Attending physician, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03844477    
Other Study ID Numbers: cuixulei6
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Pain
Pain
Neurologic Manifestations