Continuous Paravertebral Block on Postoperative Quality of Recovery After Hepatectomy

NCT03777644 | Completed

• 1 other identifier: cuixulei7
• 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

Nerve Block

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 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

• post operative length of stay

  Up to 2 weeks

• time to out-of bed activity/ambutation

  Up to 2 weeks

• time to resumption of bowel movement

  Up to 2 weeks after surgery

Study Arms (2)

TPVB + PCA

EXPERIMENTAL

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

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

placebo TPVB + PCA

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 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 0.5%ropivacaine 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, infusion rate: 0.125ml/kg/pulse,1pulse/h given through the catheter inserted in the T8 paravertebral space following the single dose Drug: Morphine given as IPCA bolus: 2mg, lock time: 5min, 1h limitation: 8mg

TPVB + PCA

Continuous Paravertebral Block with Saline PROCEDURE

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 saline,25ml in total given immediately after the correct position of the tip of the needle has been confirmed Drug: continuously infusion of saline 0.9% saline, infusion rate: 0.125ml/kg/pulse,1pulse/h given through the catheter inserted in the T8 paravertebral space following the single dose

placebo TPVB + PCA

Patient-controlled analgesia with morphine DRUG

Drug: Morphine given as IPCA bolus: 2mg, lock time: 5min, 1h limitation: 8mg

TPVB + PCA; placebo TPVB + PCA

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

Interventions

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

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 Design

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

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 17, 2018
• Study Start: November 1, 2018
• Primary Completion: May 12, 2019
• Study Completion: May 19, 2019
• Last Updated: June 25, 2020

Record last verified: 2020-06

Locations

CN (1)