Continuous Paravertebral Block on Postoperative Quality of Recovery After Hepatectomy

NCT ID: NCT03777644

Last Updated: 2020-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-05-19

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

TPVB + PCA

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

Group Type: EXPERIMENTAL

Continuous Paravertebral block with ropivacaine

Intervention Type: 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

Patient-controlled analgesia with morphine

Intervention Type: DRUG

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

placebo TPVB + PCA

Continuous Paravertebral Block with Saline and Patient-controlled analgesia with morphine

Group Type: PLACEBO_COMPARATOR

Continuous Paravertebral Block with Saline

Intervention Type: 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

Patient-controlled analgesia with morphine

Intervention Type: DRUG

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

Interventions

Continuous Paravertebral block with ropivacaine

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

Intervention Type: PROCEDURE

Continuous Paravertebral Block with Saline

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

Intervention Type: PROCEDURE

Patient-controlled analgesia with morphine

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

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cui Xulei

OTHER

Sponsor Role: lead

Responsible Party

Cui Xulei

attending physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Peking Union Medical College Hospital

Beijing, , China

Countries

China

Other Identifiers

cuixulei7

Identifier Type: -

Identifier Source: org_study_id