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TQLB for Postoperative Pain After Laparoscopic Partial Nephrectomy

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: NCT03982784
Recruitment Status : Completed
First Posted : June 12, 2019
Last Update Posted : November 13, 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,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 partial nephrectomy.

Condition or disease Intervention/treatment Phase
Laparoscopic Renal Surgery Pain Management Nerve Block Procedure: single-injection TQLB(transmuscular quadratus lumborum block) Drug: Morphine given as IPCA(intravenous patient controlled analgesia) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Transmuscular Quadratus Lumborum Block for Postoperative Pain After Laparoscopic Partial Nephrectomy: A Randomized Controlled Trial
Actual Study Start Date : June 10, 2019
Actual Primary Completion Date : November 1, 2019
Actual Study Completion Date : November 10, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: single-injection TQLB(transmuscular quadratus lumborum block)
Single-injection of TQLB is given preoperatively + postoperative IPCA(intravenous patient controlled analgesia)
Procedure: single-injection TQLB(transmuscular quadratus lumborum block)
Inject 0.6ml/kg local anesthetics in between quadratus lumborum and psoas major under ultrasound guidance

Drug: Morphine given as IPCA(intravenous patient controlled analgesia)
PCIA was initiated using a pump set to deliver boluses of 1.5-2 mg of morphine with a 5-minute lockout interval and no background infusion. The maximal permitted dosage of morphine was set at 8 mg/h.

Active Comparator: Control
postoperative IPCA is given alone
Drug: Morphine given as IPCA(intravenous patient controlled analgesia)
PCIA was initiated using a pump set to deliver boluses of 1.5-2 mg of morphine with a 5-minute lockout interval and no background infusion. The maximal permitted dosage of morphine was set at 8 mg/h.




Primary Outcome Measures :
  1. cumulative morphine consumption 8 hours after surgery [ Time Frame: at the 8 hours after surgery ]

Secondary Outcome Measures :
  1. cumulative morphine consumption at other time points after surgery [ Time Frame: at 0, 2, 4, 12, 24 and 48 hours after surgery ]
  2. The pain scores(at rest or on activity) determined by the numeric rating scale (NRS, 0-10) [ Time Frame: at 0, 2, 4, 8,12, 24, 48 and 72 hours after surgery ]
    NRS is an internationally recognized pain scale with 11 points ranging from 0 to 10 points, with 0 defined as no pain and 10 defined as the worst pain imaginable.

  3. episodes of nausea and vomiting [ Time Frame: within 24 hours after the surgery ]
  4. ambulation time [ Time Frame: within the 5 days after surgery ]
    time from the end of the surgery to the first time to out-of-bed activity

  5. time of recovery of bowl movement [ Time Frame: within the 5 days after surgery ]
    time from the end of the surgery to the first time of bowl movement

  6. patient satisfaction with anesthesia [ Time Frame: at 48 hours after surgery ]
    Patient satisfaction with anesthesia was assessed using a 5-point scale (5: very satisfied; 4: satisfied; 3: neither satisfied nor dissatisfied; 2: dissatisfied; 1: very dissatisfied)

  7. quality of recovery evaluated by the self-assessment 15-item quality of recovery (QoR) scale [ Time Frame: at 72 hours and 120 hours after the sugery ]
    QoR is a 15-item questionnaire which will score on a scale of 0-10 pertaining to patient's comfort, support system, pain, well-being, and ability to carry out daily activities, where 0 indicates none of the time and 10 indicates all of the time

  8. postoperative length of hospital stay [ Time Frame: within 2 weeks after the surgery ]
    time to patient's discharge



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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 partial 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): NCT03982784


Locations
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China, Beijing
Cui Xulei
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Cui Xulei
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Responsible Party: Cui Xulei, attending physician, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03982784    
Other Study ID Numbers: cxl2
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents