Kidney Stone
Conditions
Keywords
Postoperative pain, Transmuscular quadratus lumborum block, Block, Ropivacaine, TQL, percutaneous nephrolithotomy, PNL, Ultrasound-guided
Brief summary
Patients undergoing percutaneous nephrolithotomy (PNL) suffer from acute postoperative pain, despite a multimodal analgesic regime. We hypothesize that active (ropivacaine) transmuscular quadratus lumborum (TQL) block will significantly reduce postoperative opioid consumption and pain following PNL operation compared with placebo (saline) TQL block. The aim of this study is to investigate the effect of ultrasound-guided (USG) TQL block concurrent with a multimodal analgesic regime compared to the multimodal analgesic regime alone (and placebo TQL block) in a randomized and placebo controlled design.
Detailed description
Patients undergoing percutaneous nephrolithotomy (PNL) suffer from acute postoperative pain, despite a multimodal analgesic regime, and the patients receive considerable amounts of long lasting opioids. For the patients this greatly increase the risk of experiencing the adverse effects of opioids. The ultrasound-guided (USG) transmuscular quadratus lumborum (TQL) block is a single dosage of local anesthetic (LA) delivered in the plane between the psoas major muscle and the quadratus lumborum muscle. LA spreads cephalad into the thoracic paravertebral space to reach the somatic ventral rami (intercostal nerves) and the thoracic sympathetic trunk. The TQL block can reduce visceral pain and pain originating from the abdominal wall and has an expected duration of analgesic efficacy of 24 hours. The aim of this study is to investigate the efficacy of the active USG TQL block together with the multimodal analgesic regime to reduce postoperative opioid consumption and pain compared to placebo USG TQL block and the multimodal analgesic regime in a randomized and placebo controlled design.
Interventions
PROCEDURERopivacaine TQL block
Unilateral ultrasound-guided TQL block with 30 mL ropivacaine 0.75% 30 min prior to the surgical procedure
PROCEDURESaline TQL block
Unilateral ultrasound-guided TQL block with 30 mL of saline 0,9% 30 min prior to the surgical procedure
DRUGRopivacaine
DRUGSaline
DEVICEUltrasound
Sponsors
Zealand University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Scheduled for elective PNL operation in general anaesthesia with propofol and remifentanil. Received oral and written information about the trial Signed the informed consent American Society of Anesthesiologists (ASA) classification 1-3
Exclusion criteria
Cannot cooperate Does not speak or understand Danish Allergy towards drugs used in the trial Large daily consumption of opioids Known alcohol or drug abuse Difficulty or inability to visualize the relevant muscular or fascial structures necessary to perform the USG-TQL block Pregnancy \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total morphine consumption | 6 hours postoperatively | Morphine consumption in the first 6 hours postoperatively - data from PCA pump and patient medical record |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain score at rest (NRS 0-10/10) | 15 min, 30 min, 1 h, 2h, 4h, 6h, 12h, 18h, 24 hours postoperatively | Pain score NRS |
| Pain score at sitting position (NRS 0-10/10) | 15 min, 30 min, 1 h, 2h, 4h, 6h, 12h, 18h, 24 hours postoperatively | Pain score NRS |
| Total morphine consumption | 15 min, 30 min, 1 h, 2h, 4h, 6h, 12h, 18h, 24 hours postoperatively | Data from PCA pump and patient electronic file |
| Opioid side effects (nausea, vomiting) | 0-24 hours postoperatively | PONV, number of episodes, antiemetics |
| NRS score during application of the TQL block (NRS 0-10/10) | intraoperative | Procedure discomfort |
| Time to first ambulation - get out of bed | 0-24 hours postoperatively | Time to first ambulation from bed to walk on the floor |
Outcome results
None listed