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Completed

NCT Number: NCT03982784

TQLB for Postoperative Pain After Laparoscopic Partial Nephrectomy

This prospective, randomized study,control study aims to compare the analgesic effect,opioids consumption,quality of recovery,length of hospital stay，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 partial nephrectomy.

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Key information

Conditions

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

Age range

17 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cui Xulei

Beijing, Beijing Municipality, 100730, 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 partial 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)

Treatment and study plan

single-injection TQLB(transmuscular quadratus lumborum block)

Procedure

Inject 0.6ml/kg local anesthetics in between quadratus lumborum and psoas major under ultrasound guidance

Morphine given as IPCA(intravenous patient controlled analgesia)

Drug

PCIA was initiated using a pump set to deliver boluses of 1.5-2 mg of morphine with a 5-minute lockout interval and no background infusion. The maximal permitted dosage of morphine was set at 8 mg/h.

Primary outcomes

  1. cumulative morphine consumption 8 hours after surgery

    Time frame: at the 8 hours after surgery

Secondary outcomes

  1. cumulative morphine consumption at other time points after surgery

    Time frame: at 0, 2, 4, 12, 24 and 48 hours after surgery

  2. The pain scores(at rest or on activity) determined by the numeric rating scale (NRS, 0-10)

    Time frame: at 0, 2, 4, 8,12, 24, 48 and 72 hours after surgery

    NRS is an internationally recognized pain scale with 11 points ranging from 0 to 10 points, with 0 defined as no pain and 10 defined as the worst pain imaginable.

  3. episodes of nausea and vomiting

    Time frame: within 24 hours after the surgery

  4. ambulation time

    Time frame: within the 5 days after surgery

    time from the end of the surgery to the first time to out-of-bed activity

  5. time of recovery of bowl movement

    Time frame: within the 5 days after surgery

    time from the end of the surgery to the first time of bowl movement

  6. patient satisfaction with anesthesia

    Time frame: at 48 hours after surgery

    Patient satisfaction with anesthesia was assessed using a 5-point scale (5: very satisfied; 4: satisfied; 3: neither satisfied nor dissatisfied; 2: dissatisfied; 1: very dissatisfied)

  7. quality of recovery evaluated by the self-assessment 15-item quality of recovery (QoR) scale

    Time frame: at 72 hours and 120 hours after the sugery

    QoR is a 15-item questionnaire which will score on a scale of 0-10 pertaining to patient's comfort, support system, pain, well-being, and ability to carry out daily activities, where 0 indicates none of the time and 10 indicates all of the time

  8. postoperative length of hospital stay

    Time frame: within 2 weeks after the surgery

    time to patient's discharge

Sponsors and collaborators

Lead sponsor

Cui Xulei

Other

Registry information

Official study title

Transmuscular Quadratus Lumborum Block for Postoperative Pain After Laparoscopic Partial Nephrectomy: A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 12, 2019
Registry last updated
Nov 13, 2019

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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