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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Transmuscular Quadratus Lumborum Block for Postoperative Pain After Laparoscopic Adrenalectomy

Clinicaltrials.gov identifier NCT03942237

Recruitment Status Completed

First Posted May 8, 2019

Last update posted January 2, 2020

Study Description

Brief summary:

This prospective, randomized control study aims to compare the analgesic effect, satisfaction with anesthesia and analgesia between single-injection QLB (quadratus lumborum block)+general anesthesia (GA) and general anesthesia (GA) alone in patients undergoing laparoscopic adrenalectomy.

  • Condition or Disease:Pain Management
    Nerve Block
    Laparoscopic Adrenalectomy
  • Intervention/Treatment: Procedure: single-injection QLB(quadratus lumborum block)
    Procedure: Placebo Control
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 72 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Transmuscular Quadratus Lumborum Block for Postoperative Pain After Laparoscopic Adrenalectomy
  • Actual Study Start Date: May 2019
  • Actual Primary Completion Date: August 2019
  • Actual Study Completion Date: September 2019
Arms and interventions
Arm Intervention/treatment
Experimental: single-injection QLB (quadratus lumborum block)
Single-injection of QLB with local anesthetic is given preoperatively
Procedure: single-injection QLB(quadratus lumborum block)
Inject 0.4ml/kg 0.5% ropivacaine between quadratus lumborum and psoas major muscle Device: The curved (C1-5) probe of Ultrasound Scanner Philips CX50 is used for scan Drug: single dose ropivacaine 0.4ml/kg 0.5% ropivacaine is given immediately after the correct position of needle tip is verified.
Placebo Comparator: Placebo control
Single-injection of QLB with NS is given preoperatively
Procedure: Placebo Control
Inject 0.4ml/kg saline between quadratus lumborum and psoas major muscle Device: The curved (C1-5) probe of Ultrasound Scanner Philips CX50 is used for scan Drug: single dose 0.4ml/kg 0.9% NS is given immediately after the correct position of the needle tip is verified
Outcome Measures
  • Primary Outcome Measures: 1. the NRS pain scores on activity 12-hours after surgery [ Time Frame: 12-hours after surgery ]
    The NRS (a number scale from 0 to 10) is a commonly used pain intensity rating tool
  • Secondary Outcome Measures: 1. the pain scores at rest determined by the numeric rating scale (NRS, 0-10) [ Time Frame: At 2,4, 8, 12, 24 ,48,72 hours after the surgery ]
    The NRS (a number scale from 0 to 10) is a commonly used pain intensity rating tool
  • 2. incidence of postoperative nausea and vomiting (PONV) [ Time Frame: within 24 postoperative hours ]
  • 3. ambulation time [ Time Frame: within 5 days after surgery ]
  • 4. time of recovery of bowel movement [ Time Frame: within 5 days after surgery ]
    defined as the time to first flatus
  • 5. postoperative length of hospital stay [ Time Frame: up to 2 weeks after surgery ]
  • 6. patient's satisfaction of anesthesia and analgesia [ Time Frame: 48 hours after surgery ]
    use the Chinese version of Bauer questionnaire to assess the patient satisfaction of anesthesia
  • 7. the NRS pain scores on activity after surgery [ Time Frame: At 2,4, 8, 24 ,48,72 hours after the surgery ]
    The NRS (a number scale from 0 to 10) is a commonly used pain intensity rating tool
Eligibility Criteria
  • Ages Eligible for Study: 18 to 70 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Age 18-70 yrs

- American Society of Anesthesiologists physical statusⅠ-Ⅲ

- Undergo laparoscopic adrenalectomy

- Informed consent

Exclusion Criteria:

- a known allergy to the medications being used for anesthesia

- coagulopathy or on anticoagulants

- chronic opioid therapy or history of substance abuse

- participating in another RCT

- inability to properly describe postoperative pain to investigators (e.g., language
barrier, neuropsychiatric disorder).

Contacts and Locations
Contacts
Locations

China
Peking Union Medical College Hospital
Beijing

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

Study Chair: Yuguang Huang PUMCH

More Information
  • Responsible Party: Peking Union Medical College Hospital
  • ClinicalTrials.gov Identifier: NCT03942237 History of Changes
  • Other Study ID Numbers: cuixulei8
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: January 2, 2020
  • Last Verified: December 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Peking Union Medical College Hospital: transmuscular quadratus lumborum block adrenalectomy
  • Additional relevant MeSH terms: Pain, Postoperative