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

Zealand University Hospital

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Ultrasound Guided Transmuscular Quadratus Lumborum Block

Treatments: Drug: Ropivacaine; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03571490

2017-002130-23 (EudraCT Number)

V2.02.05.2017

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

TQL Ropivacaine(active)

Active Comparator group

Description:

Bilateral Single shot of ropivacaine 0.325% 30 mL. In total 60 mL of 0.325% ropivacaine

Treatment:

Drug: Ropivacaine

TQL saline (placebo)

Placebo Comparator group

Description:

Bilateral single shot of saline 0.9% 30 mL. in Total 60 mL of saline 0.9%

Treatment:

Drug: Saline