Skip to main content
OpenTrials
Completed

NCT Number: NCT03571490

Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Laparoscopic Hand-assisted Nephrectomy and Robot Assisted Partiel Nephrectomy

Patients with kidney cancer often undergo hand-assisted laparoscopic nephrectomy or Robot assisted partiel nephrectomy. The investigators performed a one-year retrospective study. the sudy revealed that 67% of the patients needed substantial amounts of opioids for postoperative pain management (PPM) in recovery despite a multimodal analgesic regime. In a prospective pilot study including ten laparoscopic hand-assisted nephrectomy, with severe postoperative pain the investigators found that bilateral Ultrasound-guided (USG) transmuscular quadratus lumborum (TQL) block substantially reduced pain and opioid consumption. This study aims to evaluate the effect on PPM of a bilateral USG TQL block compared to placebo.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Ultrasound Guided Transmuscular Quadratus Lumborum Block

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zealand university Hospital, Anaesthesiology

Roskilde, 4000, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • over 18 years
  • Kidney cancer
  • Have received thorough information, orally and in written
  • Signed the "Informed Consent" form on participation in the trial

Exclusion criteria

  • Inability to cooperate
  • Inability to speak and understand Danish both orally and written
  • Allergy to local anaesthetics or opioids
  • Daily intake of opioids
  • Local infection at the site of injection or systemic infection
  • Difficulty visualisation of muscular and fascial structures in ultrasound visualisation necessary to the block administration
  • Known abuse of alcohol or medicine
  • Pregnancy

Treatment and study plan

Ropivacaine

Drug

Single shot of ropivacaine 0.325%

Saline

Drug

Single shot of saline 0.9%

Primary outcomes

  1. opioid consumption

    Time frame: 12 hours postoperatively

    Opioid consumption postoperatively: data from Patient Controlled Analgesia(PCA) pump and patient medical record).

Secondary outcomes

  1. opioid consumption

    Time frame: 6 hours postoperatively

    Opioid consumption postoperatively (data from PCA pump and patient medical record).

  2. opioid consumption

    Time frame: 18 hours postoperatively

    Opioid consumption postoperatively (data from PCA pump and patient medical record).

  3. opioid consumption

    Time frame: 24 hours postoperatively

    Opioid consumption postoperatively (data from PCA pump and patient medical record).

  4. NRS score

    Time frame: 12 hours postoperatively

    Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain postoperatively at rest and activity

  5. NRS score at rest and activity

    Time frame: 6 hours postoperatively

    Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain

  6. NRS score at rest and activity

    Time frame: 18 hours postoperatively

    Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain

  7. NRS score at rest and activity

    Time frame: 24 hours postoperatively

    Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain

  8. Opioid-related side effects

    Time frame: 6 hours postoperatively

    The degree of morphine-related side effects (PONV, itching, fatigue, etc.)

  9. Opioid-related side effects

    Time frame: 12 hours postoperatively

    The degree of morphine-related side effects (PONV, itching, fatigue, etc.)

  10. Opioid-related side effects

    Time frame: 18 hours postoperatively

    The degree of morphine-related side effects (PONV, itching, fatigue, etc.)

  11. Opioid-related side effects

    Time frame: 24 hours postoperatively

    The degree of morphine-related side effects (PONV, itching, fatigue, etc.)

  12. Patient satisfaction with application of the block. NRS

    Time frame: Immediately after application of the block

    Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain

  13. Ambulation

    Time frame: within 24 hours postoperatively

    Time from operation to ambulation

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study title

Improving Postoperative Pain Management With the Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Laparoscopic Hand-assisted Nephrectomy and Robot-assisted Partiel Nephrectomy: A Double Blind, Randomized, Placebo Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 27, 2018
Registry last updated
Mar 19, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.