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Completed

NCT Number: NCT03942237

Transmuscular Quadratus Lumborum Block for Postoperative Pain After Laparoscopic Adrenalectomy

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.

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Key information

Conditions

Pain Management Agnosia Laparoscopic Adrenalectomy Nerve Block Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

single-injection QLB(quadratus lumborum block)

Procedure

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 Control

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 8, 2019
Registry last updated
Jan 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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