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Completed

NCT Number: NCT03990922

CTPVB for Hepatectomy

Moderate to severe postoperative pain often influence patients quality of recovery after hepatectomy. Systemic opioids given with patient-controlled analgesia has been used after hepatectomy in many medical center, but the analgesic effect can be limited and undesirable side effects may bring about negative effects on patients recovery. Regional block has been proved to improve patients postoperative recovery in many kinds of surgeries.

The investigators therefore designed a prospective, randomized, subject and assessor blinded, parallel-group, placebo controlled study to test the hypothesis that continuous right thoracic paravertebral block increase patients quality of recovery score on the 7th postoperative day after hepatectomy in patients receiving i.v. patient-controlled analgesia (PCA) with morphine.

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Key information

Conditions

Pain Management Agnosia Hepatectomy Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Paravertebral Block 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

Peking Union Medical College Hospital

Beijing, 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

Continuous Paravertebral block with ropivacaine

Procedure

Inject 25 ml 0.5% ropivacaine in the T8 paravertebral space followed with catheter insertion and continuous 0.2% ropivacaine infusion(infusion rate: 0.125ml/kg/pulse,1pulse/h).

Continuous Paravertebral "block" with saline

Procedure

Inject 25 ml 0.9% saline in the T8 paravertebral space followed with catheter insertion and continuous 0.9% ropivacaine infusion(infusion rate: 0.125ml/kg/pulse,1pulse/h).

Patient-controlled analgesia with morphine

Drug

Morphine given as intravenous patient-controlled analgesia bolus: 2mg, lock time: 5min, 1h limitation: 8mg

Primary outcomes

  1. the postoperative recovery quality on postoperative day 7

    Time frame: at the 7th postoperative day

    The postoperative recovery quality is evaluated with QoR-15 questionnaire. The QoR-15 is a 15-item questionnaire intended to measure QoR after anesthesia and surgery. It comprises five subscales: pain (2 items), physical comfort (5 items), physical independence (2 items), psychological support (2 items), and emotional state (4 items) [2 Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR- 15. Anesthesiology. 2013;118(6):1332.]. Each item is scored from 0 to 10, and the possible total score ranges from 0(extremely poor quality of recovery) to 150 (excellent quality of re covery).

Secondary outcomes

  1. the postoperative recovery quality on postoperative day 3

    Time frame: at the 3th postoperative day

    QoR-15 questionnaire The postoperative recovery quality is evaluated with QoR-15 questionnaire. The QoR-15 is a 15-item questionnaire intended to measure QoR after anesthesia and surgery. It comprises five subscales: pain (2 items), physical comfort (5 items), physical independence (2 items), psychological support (2 items), and emotional state (4 items) [2 Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR- 15. Anesthesiology. 2013;118(6):1332.]. Each item is scored from 0 to 10, and the possible total score ranges from 0(extremely poor quality of recovery) to 150 (excellent quality of re covery).

  2. The pain scores determined by the numeric rating scale (NRS, 0-10)

    Time frame: At 8, 24,48 hours after the surgery

    The patients evaluated their pain severity with thenumeric rating scale (NRS, 0-10),where 0 indicates no pain, and 10 indicates the most severe pain

  3. cumulated morphine consumption

    Time frame: At 8, 24,48 hours after the surgery

  4. time to resumption of bowel movement

    Time frame: Up to 2 weeks after surgery

  5. time to out-of bed activity/ambutation

    Time frame: Up to 2 weeks

  6. post operative length of stay

    Time frame: Up to 2 weeks

Sponsors and collaborators

Lead sponsor

Cui Xulei

Other

Registry information

Official study title

Continuous Thoracic Paravertebral Block for Open Hepatectomy

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 19, 2019
Registry last updated
Jan 2, 2020

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

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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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