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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03571490
Enrollment
50
Registered
2018-06-27
Start date
2018-06-26
Completion date
2019-06-24
Last updated
2020-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Ultrasound Guided Transmuscular Quadratus Lumborum Block

Brief summary

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.

Interventions

DRUGRopivacaine

Single shot of ropivacaine 0.325%

DRUGSaline

Single shot of saline 0.9%

Sponsors

Zealand University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

Double blind

Intervention model description

Double blind placebo Controlled Trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
opioid consumption12 hours postoperativelyOpioid consumption postoperatively: data from Patient Controlled Analgesia(PCA) pump and patient medical record).

Secondary

MeasureTime frameDescription
NRS score12 hours postoperativelyNumeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain postoperatively at rest and activity
NRS score at rest and activity6 hours postoperativelyNumeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain
opioid consumption6 hours postoperativelyOpioid consumption postoperatively (data from PCA pump and patient medical record).
Patient satisfaction with application of the block. NRSImmediately after application of the blockNumeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain
Ambulationwithin 24 hours postoperativelyTime from operation to ambulation
Opioid-related side effects6 hours postoperativelyThe degree of morphine-related side effects (PONV, itching, fatigue, etc.)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026