CTPVB for Hepatectomy

NCT03990922 | Completed

• 1 other identifier: PVB_H
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain Management; Paravertebral Block; Hepatectomy

Outcome Measures

Primary Outcomes (1)

• the postoperative recovery quality on postoperative day 7

  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).

  at the 7th postoperative day

Secondary Outcomes (6)

• the postoperative recovery quality on postoperative day 3

  at the 3th postoperative day

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

  At 8, 24,48 hours after the surgery

• cumulated morphine consumption

  At 8, 24,48 hours after the surgery

• time to resumption of bowel movement

  Up to 2 weeks after surgery

• time to out-of bed activity/ambutation

  Up to 2 weeks

Study Arms (2)

CTPVB with ropivocaine

EXPERIMENTAL

Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with morphine

Procedure: Continuous Paravertebral block with ropivacaine; Drug: Patient-controlled analgesia with morphine

CTPVB with saline

PLACEBO COMPARATOR

Continuous Paravertebral block with saline and Patient-controlled analgesia with morphine

Procedure: Continuous Paravertebral "block" with saline; Drug: Patient-controlled analgesia with morphine

Interventions

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).

CTPVB with ropivocaine

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).

CTPVB with saline

Patient-controlled analgesia with morphine DRUG

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

CTPVB with ropivocaine; CTPVB with saline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 yrs
• American Society of Anesthesiologists physical statusⅠ-Ⅲ
• Undergo hepatectomy with J-shape subcostal incision
• Informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cui Xulei: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Conditions

Agnosia

Interventions

Ropivacaine; Sodium Chloride; Analgesia, Patient-Controlled; Morphine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Analgesia; Anesthesia and Analgesia; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• xulei cui, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: attending physician

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 19, 2019
• Study Start: June 20, 2019
• Primary Completion: November 9, 2019
• Study Completion: November 17, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Locations

CN (1)