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Continous Quadratus Lumborum Block for Hepatic Surgery With Right Subcostal Incision

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: NCT02914015
Recruitment Status : Terminated (we change the study protocol)
First Posted : September 26, 2016
Last Update Posted : September 4, 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 et al. between unilateral continuous quadratus lumborum block (QLB) and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing hepatectomy with right J-shape subcostal incision.

Condition or disease Intervention/treatment Phase
Hepatectomy Analgesia Nerve Block Procedure: Continous QLB (quadratus lumborum block) Device: Philip CX50 Ultrasound Scanner Drug: Ropivacaine Drug: Morphine given as IPCA Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Ultrasound-guided Continous Quadratus Lumborum Block: Effect on Acute Pain and Quality of Recovery After Hepatic Surgery With Right Subcostal Incision
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : May 29, 2019
Actual Study Completion Date : May 29, 2019

Arm Intervention/treatment
Experimental: Continuous QLB+postoperative IPCA
Single-injection of QLB (quadratus lumborum block) is given preoperatively followed with continuous infusion+ postoperative IPCA (intravenous patient control analgesia)
Procedure: Continous QLB (quadratus lumborum block)
Inject local anesthetics in between quadratus lumborum and psoas major muscle with catheter insertion and continuous local infusion
Other Name: Inject local anesthetics in between quadratus lumborum and psoas major muscle with catheter insertion and continuous local infusion

Device: Philip CX50 Ultrasound Scanner
The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scan

Drug: 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.
  • followed with 0.2% ropivacaine infusion at a rate of 0.125ml/kg/h given through the catheter inserted in between the quadratus lumborum muscle and psoas major muscle.

Drug: Morphine given as IPCA
Bolus: 1-2mg, lock time: 10min, 1h limitation: 5-10mg. without background infusion.

Active Comparator: IPCA
Postoperative IPCA (intravenous patient control analgesia) is given alone
Drug: Morphine given as IPCA
Bolus: 1-2mg, lock time: 10min, 1h limitation: 5-10mg. without background infusion.




Primary Outcome Measures :
  1. Cumulative morphine consumption [ Time Frame: at 24 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 ,48,72 hours and 7 day after the surgery ]
  2. Nausea and Vomiting score [ Time Frame: At 0, 2,4, 8, 12, 24 and 48 hours after the surgery ]
  3. Pruritus score [ Time Frame: At 0, 2,4, 8, 12, 24 and 48 hours 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 7 days after surgery ]
  6. Quality of recovery [ Time Frame: 3 days and 7 days after surgery ]
    use the self-assessment 11 item QoR scale to assess the patient's recovery quality

  7. Patient satisfaction with anesthesia [ Time Frame: 48 hours after surgery ]
    use the Chinese version Bauer questionnaire to assess the patient satisfaction with anesthesia

  8. Postoperative hospital length of stay [ Time Frame: Up to 6 weeks ]


Information from the National Library of Medicine

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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 hepatectomy with right J-shape subcostal incision
  • 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): NCT02914015


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: NCT02914015    
Other Study ID Numbers: CXL4
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Surgical Wound
Wounds and Injuries
Morphine
Ropivacaine
Anesthetics, Local
Anesthetics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents