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Thoracic Paravertebral Block : Effect on Acute Pain and Chronic Pain of Hepatectomy With Right J-shape Subcostal Incision

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ClinicalTrials.gov Identifier: NCT02817321
Recruitment Status : Completed
First Posted : June 29, 2016
Last Update Posted : January 8, 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. single-injection TPVB +continuous(pulsatile infusion) TPVB 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: single-injection TPVB + continuous TPVB Device: Philip CX50 Ultrasound Scanner Device: PAJUNK Contiplex S Catheter Drug: single dose ropivacaine Drug: continuously infusion of ropivacaine Drug: Morphine given as IPCA Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Actual Study Start Date : November 2016
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Single-injection TPVB +continuous TPVB
Single-injection of TPVB is given preoperatively followed with continuous infusion+ postoperative IPCA.
Procedure: single-injection TPVB + continuous TPVB
Inject local anesthetics in the T8 paravertebral space followed 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 scanning

Device: PAJUNK Contiplex S Catheter
Drug: single dose ropivacaine
  • 2mg/kg ropivacaine in saline with 1:200,000 adrenaline, 25ml in total
  • given immediately after the correct position of the tip of the needle has been confirmed

Drug: continuously infusion of ropivacaine
  • 0.2% ropivacaine, pulse dosadge: 0.125ml/kg/pulse, 1pulse/h at a rate of 6ml/minutes
  • given through the catheter inserted in the T8 paravertebral space following the single dose

Drug: Morphine given as IPCA
bolus: 2mg, lock time: 10min, 1h limitation: 8mg

Active Comparator: IPCA
postoperative IPCA is given alone
Drug: Morphine given as IPCA
bolus: 2mg, lock time: 10min, 1h limitation: 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 and 7day after the surgery ]
  2. nausea and vomiting score [ Time Frame: At 0, 2,4, 8, 12, 24 and 48hours after the surgery ]
  3. pruritus score [ Time Frame: At 0, 2,4, 8, 12, 24 and 48hours 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. Postoperative hospital length of stay [ Time Frame: Up to 4 weeks ]
  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. data collection of chronic pain [ Time Frame: at 3,6,12 months after surgery ]
    Patients undergo a telephone interview with a questionnaire at 3, 6 and 12 months after surgery, the incidence and severity of chronic pain is recorded.



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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 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): NCT02817321


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: NCT02817321    
Other Study ID Numbers: cuixulei2
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 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