Thoracic Paravertebral Block : Effect on Acute Pain and Chronic Pain of Hepatectomy With Right J-shape Subcostal Incision

Analgesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02817321
• Other study ID #: cuixulei2
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: November 2018

Study information

• Verified date: January 2019
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective, randomized study,control study aims to compare the analgesic effect,opioids consumption,quality of recovery,length of hospital stay and incidence of chronic pain,et al. single-injection TPVB +continuous(pulsatile infusion) TPVB and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing hepatectomy with right J-shape subcostal incision.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 2018
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 18-70 yrs

• American Society of Anesthesiologists physical status?-?

• 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)

Related Conditions & MeSH terms

• Analgesia
• Hepatectomy
• Nerve Block

Intervention

Procedure:
• single-injection TPVB + continuous TPVB
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
• PAJUNK Contiplex S Catheter

Drug:
• single dose ropivacaine
2mg/kg ropivacaine in saline with 1:200,000 adrenaline, 25ml in total given immediately after the correct position of the tip of the needle has been confirmed
• continuously infusion of ropivacaine
0.2% ropivacaine, pulse dosadge: 0.125ml/kg/pulse, 1pulse/h at a rate of 6ml/minutes given through the catheter inserted in the T8 paravertebral space following the single dose
• Morphine given as IPCA
bolus: 2mg, lock time: 10min, 1h limitation: 8mg

Locations

Country	Name	City	State
China	Xulei CUI	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cui Xulei

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative morphine consumption		within 48 postoperative hours
Secondary	The pain scores determined by the numeric rating scale (NRS, 0-10)		At 0, 2,4, 8, 12, 24 ,48,72hours and 7day after the surgery
Secondary	nausea and vomiting score		At 0, 2,4, 8, 12, 24 and 48hours after the surgery
Secondary	pruritus score		At 0, 2,4, 8, 12, 24 and 48hours after the surgery
Secondary	ambulation time		within the 7 days after surgery
Secondary	time of recovery of bowl movement		within the 7 days after surgery
Secondary	Postoperative hospital length of stay		Up to 4 weeks
Secondary	patient satisfaction with anesthesia	use the Chinese version Bauer questionnaire to assess the patient satisfaction with anesthesia	48 hours after surgery
Secondary	data collection of chronic pain	Patients undergo a telephone interview with a questionnaire at 3, 6 and 12 months after surgery, the incidence and severity of chronic pain is recorded.	at 3,6,12 months after surgery