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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03844477
Other study ID # cuixulei6
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 16, 2019
Est. completion date May 15, 2019

Study information

Verified date September 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 ,control study aims to compare the analgesic effect,quality of recovery, length of hospital stay ,et al. between single-injection QLB(quadratus lumborum block)+general anesthesia (GA) and general anesthesia (GA) alone in patients undergoing laparoscopic adrenalectomy.


Recruitment information / eligibility

Status Terminated
Enrollment 25
Est. completion date May 15, 2019
Est. primary completion date May 1, 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 laparoscopic adrenalectomy

- 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


Intervention

Procedure:
single-injection QLB(quadratus lumborum block)
Inject 0.4ml/kg 0.5% ropivacaine between quadratus lumborum and psoas major without continuous local infusion Device: Ultrasound Scanner The curved (C1-5) probe of Ultrasound Scanner is used for scan Device: PAJUNK StimuLong Drug: single dose ropivacaine 0.4ml/kg 0.5% ropivacaine given immediately after the correct position of the tip of the needle has been verified.
Placebo control
Inject 0.4ml/kg saline between quadratus lumborum and psoas major without continuous local infusion Device: Ultrasound Scanner The curved (C1-5) probe of Ultrasound Scanner is used for scan Device: PAJUNK StimuLong Drug: single dose 0.4ml/kg 0.9% NS. given immediately after the correct position of the tip of the needle has been verified.

Locations

Country Name City State
China Peking Union Medical College Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary pain numeric rating scale (NRS, 0-10)pain score at activity at 12 hours after surgery At 12hours after the surgery
Secondary The pain scores at rest determined by the numeric rating scale (NRS, 0-10) At 2,4, 8, 12,24 ,48,72hours after the surgery
Secondary incidence of postoperative nausea and vomiting (PONV) within 24 postoperative hours
Secondary ambulation time within5 days after surgery
Secondary time of restart anal exhaust within 5 days after surgery
Secondary Postoperative length of hospital stay up to2 weeks after surgery
Secondary patient's satisfaction with anesthesia and analgesia use the Chinese version Bauer questionnaire to assess the patient satisfaction with anesthesia and analgesia 48 hours after surgery
Secondary The pain scores at activity determined by the numeric rating scale (NRS, 0-10) At 2,4, 8, 24 ,48,72hours after the surgery
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