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Continous Quadratus Lumborum Block for Hepatic Surgery With Right Subcostal Incision

Sponsor
Cui Xulei (Other)
Overall Status
Terminated
CT.gov ID
NCT02914015
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
9.9
Actual Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Continous QLB (quadratus lumborum block)
  • Device: Philip CX50 Ultrasound Scanner
  • Drug: Ropivacaine
  • Drug: Morphine given as IPCA
 N/A

Study Design

Study Type:
Interventional
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 :
Aug 1, 2018
Actual Primary Completion Date :
May 29, 2019
Actual Study Completion Date :
May 29, 2019

Arms and Interventions

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 Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Cumulative morphine consumption [at 24 postoperative hours]

    Secondary Outcome Measures

    1. The pain scores determined by the numeric rating scale (NRS, 0-10) [At 0, 2,4, 8, 12, 24 ,48,72 hours and 7 day after the surgery]

    2. Nausea and Vomiting score [At 0, 2,4, 8, 12, 24 and 48 hours after the surgery]

    3. Pruritus score [At 0, 2,4, 8, 12, 24 and 48 hours after the surgery]

    4. Ambulation time [within the 7 days after surgery]

    5. Time of recovery of bowl movement [within the 7 days after surgery]

    6. Quality of recovery [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 [48 hours after surgery]

      use the Chinese version Bauer questionnaire to assess the patient satisfaction with anesthesia

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xulei CUI Beijing Beijing China 100730

    Sponsors and Collaborators

    • Cui Xulei

    Investigators

    • Study Chair: Yuguang Huang, MD., Peking Union Medical College Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cui Xulei, Attending Physician, Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT02914015
    Other Study ID Numbers:
    • CXL4
    First Posted:
    Sep 26, 2016
    Last Update Posted:
    Sep 4, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Morphine
    Ropivacaine
    Anesthetics, Local
    Anesthetics

    Study Results

    No Results Posted as of Sep 4, 2019