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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02841982
Other study ID # cuixulei3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2016
Est. completion date December 2018

Study information

Verified date May 2019
Source Peking Union Medical College Hospital
Contact n/a
Is FDA regulated No
Health authority
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. between single-injection QLB(quadratus lumborum block)+ intravenous patient-controlled analgesia (IPCA) and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing laparoscopic renal surgeries.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2018
Est. primary completion date November 2018
Accepts healthy volunteers No
Gender All
Age group 17 Years to 80 Years
Eligibility Inclusion Criteria:

- Age 18-70 yrs

- American Society of Anesthesiologists physical status?-?

- Undergo laparoscopic nephrectomy

- 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


Related Conditions & MeSH terms


Intervention

Procedure:
single-injection QLB(quadratus lumborum block)
Inject local anesthetics in between quadratus lumborum and psoas major without continuous local infusion
Device:
Philip CX50 Ultrasound Scanner
The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scan
PAJUNK StimuLong

Drug:
single dose 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.
Morphine given as IPCA(intravenous patient controlled analgesia)
bolus: 1.5~2mg, lock time: 10min, 1h limitation: 6~8mg

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 after the surgery
Secondary nausea and vomiting score within 24 hours after the surgery
Secondary pruritus score within 24hour after the surgery
Secondary ambulation time within the 7 days after surgery
Secondary time of recovery of bowl movement within the 5 days after surgery
Secondary quality of recovery use the self-assessment 15 item QoR scale to assess the patient's recovery 3days and 5days after surgery
Secondary Postoperative hospital length of stay Up to 6 weeks
Secondary patient satisfaction with anesthesia use the Chinese version Bauer questionnaire to assess the patient satisfaction with anesthesia 48 hours after surgery
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