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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

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.

Condition or disease Intervention/treatment Phase
Laparoscopic Renal Surgery Pain Management Nerve Block 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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Actual Study Start Date : August 2016
Actual Primary Completion Date : November 2018
Actual Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: single-injection QLB(quadratus lumborum block)
Single-injection of QLB is given preoperatively + postoperative IPCA(intravenous patient controlled analgesia)
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

Active Comparator: IPCA
postoperative IPCA is given alone
Drug: Morphine given as IPCA(intravenous patient controlled analgesia)
bolus: 1.5~2mg, lock time: 10min, 1h limitation: 6~8mg




Primary Outcome Measures :
  1. cumulative morphine consumption [ Time Frame: within 48 postoperative hours ]

Secondary Outcome Measures :
  1. 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 ]
  2. nausea and vomiting score [ Time Frame: within 24 hours after the surgery ]
  3. pruritus score [ Time Frame: within 24hour after the surgery ]
  4. ambulation time [ Time Frame: within the 7 days after surgery ]
  5. time of recovery of bowl movement [ Time Frame: within the 5 days after surgery ]
  6. quality of recovery [ Time Frame: 3days and 5days after surgery ]
    use the self-assessment 15 item QoR scale to assess the patient's recovery

  7. Postoperative hospital length of stay [ Time Frame: Up to 6 weeks ]
  8. patient satisfaction with anesthesia [ Time Frame: 48 hours after surgery ]
    use the Chinese version Bauer questionnaire to assess the patient satisfaction with anesthesia



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Ages Eligible for Study:   17 Years to 80 Years   (Child, 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 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)

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): NCT02841982


Locations
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China, Beijing
Xulei CUI
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Cui Xulei
Investigators
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Study Chair: Yuguang Huang, MD. Peking Union Medical College Hospital
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Responsible Party: Cui Xulei, Attending physician, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02841982    
Other Study ID Numbers: cuixulei3
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Morphine
Ropivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics