Continous Quadratus Lumborum Block for Hepatic Surgery With Right Subcostal Incision

Analgesia Clinical Trial

Official title:

Ultrasound-guided Continous Quadratus Lumborum Block: Effect on Acute Pain and Quality of Recovery After Hepatic Surgery With Right Subcostal Incision

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02914015
• Other study ID #: CXL4
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: May 29, 2019

Study information

• Verified date: September 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 et al. between unilateral continuous quadratus lumborum block (QLB) and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing hepatectomy with right J-shape subcostal incision.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: May 29, 2019
• Est. primary completion date: May 29, 2019
• 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 right 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
• Surgical Wound

Intervention

Procedure:
• Continous QLB (quadratus lumborum block)
Inject local anesthetics in between quadratus lumborum and psoas major muscle 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 scan

Drug:
• Ropivacaine
0.6ml/kg 0.5% ropivacaine with 1:200,000 adrenaline given immediately after the correct position of the tip of the needle has been verified. followed with 0.2% ropivacaine infusion at a rate of 0.125ml/kg/h given through the catheter inserted in between the quadratus lumborum muscle and psoas major muscle.
• Morphine given as IPCA
Bolus: 1-2mg, lock time: 10min, 1h limitation: 5-10mg. without background infusion.

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		at 24 postoperative hours
Secondary	The pain scores determined by the numeric rating scale (NRS, 0-10)		At 0, 2,4, 8, 12, 24 ,48,72 hours and 7 day after the surgery
Secondary	Nausea and Vomiting score		At 0, 2,4, 8, 12, 24 and 48 hours after the surgery
Secondary	Pruritus score		At 0, 2,4, 8, 12, 24 and 48 hours 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	Quality of recovery	use the self-assessment 11 item QoR scale to assess the patient's recovery quality	3 days and 7 days after surgery
Secondary	Patient satisfaction with anesthesia	use the Chinese version Bauer questionnaire to assess the patient satisfaction with anesthesia	48 hours after surgery
Secondary	Postoperative hospital length of stay		Up to 6 weeks