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

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: NCT02841982
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Cui Xulei, Peking Union Medical College Hospital

Tracking Information
First Submitted Date  ICMJE July 20, 2016
First Posted Date  ICMJE July 22, 2016
Last Update Posted Date May 20, 2019
Actual Study Start Date  ICMJE August 2016
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2018)
cumulative morphine consumption [ Time Frame: within 48 postoperative hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 20, 2016)
cumulative morphine consumption [ Time Frame: at 24 postoperative hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
  • The pain scores determined by the numeric rating scale (NRS, 0-10) [ Time Frame: At 0, 2,4, 8, 12, 24 ,48,72hours after the surgery ]
  • nausea and vomiting score [ Time Frame: within 24 hours after the surgery ]
  • pruritus score [ Time Frame: within 24hour after the surgery ]
  • ambulation time [ Time Frame: within the 7 days after surgery ]
  • time of recovery of bowl movement [ Time Frame: within the 5 days after surgery ]
  • quality of recovery [ Time Frame: 3days and 5days after surgery ]
    use the self-assessment 15 item QoR scale to assess the patient's recovery
  • Postoperative hospital length of stay [ Time Frame: Up to 6 weeks ]
  • patient satisfaction with anesthesia [ Time Frame: 48 hours after surgery ]
    use the Chinese version Bauer questionnaire to assess the patient satisfaction with anesthesia
Original Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2016)
  • The pain scores determined by the numeric rating scale (NRS, 0-10) [ Time Frame: At 0, 2,4, 8, 12, 24 ,48,72hours and 7day after the surgery ]
  • nausea and vomiting score [ Time Frame: At 0, 2,4, 8, 12, 24 and 48hours after the surgery ]
  • pruritus score [ Time Frame: At 0, 2,4, 8, 12, 24 and 48hours after the surgery ]
  • ambulation time [ Time Frame: within the 7 days after surgery ]
  • time of recovery of bowl movement [ Time Frame: within the 5 days after surgery ]
  • quality of recovery [ Time Frame: 3days and 5days after surgery ]
    use the self-assessment 11item QoR scale to assess the patient's recovery
  • Postoperative hospital length of stay [ Time Frame: Up to 6 weeks ]
  • patient satisfaction with anesthesia [ Time Frame: 48 hours after surgery ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quadratus Lumborum Block : Effect on Acute Pain and Quality of Recovery After Laparoscopic Renal Surgery
Official Title  ICMJE Not Provided
Brief Summary This prospective, randomized study,control study aims to compare the analgesic effect,opioids consumption,quality of recovery,length of hospital stay and incidence of chronic pain,et al. between single-injection QLB(quadratus lumborum block)+ intravenous patient-controlled analgesia (IPCA) and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing laparoscopic renal surgeries.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Laparoscopic Renal Surgery
  • Pain Management
  • Nerve Block
Intervention  ICMJE
  • Procedure: single-injection QLB(quadratus lumborum block)
    Inject local anesthetics in between quadratus lumborum and psoas major without continuous local infusion
  • Device: Philip CX50 Ultrasound Scanner
    The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scan
  • Device: PAJUNK StimuLong
  • Drug: single dose ropivacaine
    • 0.6ml/kg 0.5% ropivacaine with 1:200,000 adrenaline.
    • given immediately after the correct position of the tip of the needle has been verified.
  • Drug: Morphine given as IPCA(intravenous patient controlled analgesia)
    bolus: 1.5~2mg, lock time: 10min, 1h limitation: 6~8mg
Study Arms  ICMJE
  • Experimental: single-injection QLB(quadratus lumborum block)
    Single-injection of QLB is given preoperatively + postoperative IPCA(intravenous patient controlled analgesia)
    Interventions:
    • Procedure: single-injection QLB(quadratus lumborum block)
    • Device: Philip CX50 Ultrasound Scanner
    • Device: PAJUNK StimuLong
    • Drug: single dose ropivacaine
    • Drug: Morphine given as IPCA(intravenous patient controlled analgesia)
  • Active Comparator: IPCA
    postoperative IPCA is given alone
    Intervention: Drug: Morphine given as IPCA(intravenous patient controlled analgesia)
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: May 15, 2019)
30
Original Estimated Enrollment  ICMJE
 (submitted: July 20, 2016)
93
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date November 2018   (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 nephrectomy
  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years to 80 Years   (Child, 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 NCT02841982
Other Study ID Numbers  ICMJE cuixulei3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cui Xulei, Peking Union Medical College Hospital
Study Sponsor  ICMJE Cui Xulei
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Yuguang Huang, MD. Peking Union Medical College Hospital
PRS Account Peking Union Medical College Hospital
Verification Date May 2019

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