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NCT Number: NCT02817321

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

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.

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Key information

Conditions

Hepatectomy Agnosia Analgesia Nerve Block Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xulei CUI

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

single-injection TPVB + continuous TPVB

Procedure

Inject local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion.

Philip CX50 Ultrasound Scanner

Device

The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning

PAJUNK Contiplex S Catheter

Device

single dose ropivacaine

Drug
  • 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

continuously infusion of ropivacaine

Drug
  • 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

Morphine given as IPCA

Drug

bolus: 2mg, lock time: 10min, 1h limitation: 8mg

Primary outcomes

  1. cumulative morphine consumption

    Time frame: within 48 postoperative hours

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Cui Xulei

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jun 29, 2016
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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