Continuous Paravertebral Block on Postoperative Quality of Recovery After Hepatectomy

Not Applicable

Completed

• Conditions: Nerve Block
• Interventions: Procedure: Continuous Paravertebral block with ropivacaine; Procedure: Continuous Paravertebral Block with Saline; Drug: Patient-controlled analgesia with morphine

• Registration Number: NCT03777644
• Lead Sponsor: Cui Xulei

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2018-12-10
• Study First Submitted QC: 2018-12-13
• Study First Posted: 2018-12-17
• Primary Completion: 2019-05-12
• Study Completion: 2019-05-19
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-24
• Last Update Posted: 2020-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TPVB + PCA	Continuous Paravertebral block with ropivacaine	Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with morphine
TPVB + PCA	Patient-controlled analgesia with morphine	Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with morphine
placebo TPVB + PCA	Patient-controlled analgesia with morphine	Continuous Paravertebral Block with Saline and Patient-controlled analgesia with morphine
placebo TPVB + PCA	Continuous Paravertebral Block with Saline	Continuous Paravertebral Block with Saline and Patient-controlled analgesia with morphine

Primary Outcome Measures

Name	Time	Method
the postoperative recovery quality on postoperative day 7	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 Outcome Measures

Name	Time	Method
post operative length of stay	Up to 2 weeks
time to out-of bed activity/ambutation	Up to 2 weeks
the postoperative recovery quality on postoperative day 3: QoR-15 questionnaire	at the 3th 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).
cumulated morphine consumption	At 8, 24,48 hours after the surgery
time to resumption of bowel movement	Up to 2 weeks after surgery
The pain scores determined by the numeric rating scale (NRS, 0-10)	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.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China