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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine TQL block | Active Comparator | Unilateral single shot ultrasound-guided TQL block with 30 ml of ropivacaine 0.75% |
|
| Placebo TQL block | Placebo Comparator | Unilateral single shot ultrasound-guided TQL block with 30 ml saline 0.9% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine TQL block | Procedure | Unilateral ultrasound-guided TQL block with 30 mL ropivacaine 0.75% 30 min prior to the surgical procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total morphine consumption | Morphine consumption in the first 6 hours postoperatively - data from PCA pump and patient medical record | 6 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Total morphine consumption | Data from PCA pump and patient electronic file | 15 min, 30 min, 1 h, 2h, 4h, 6h, 12h, 18h, 24 hours postoperatively |
| Pain score at rest (NRS 0-10/10) | Pain score NRS |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Mette Dam, MD, PhD Fellow | Zealand University Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26771297 | Background | Hansen CK, Dam M, Bendtsen TF, Borglum J. Ultrasound-Guided Quadratus Lumborum Blocks: Definition of the Clinical Relevant Endpoint of Injection and the Safest Approach. A A Case Rep. 2016 Jan 15;6(2):39. doi: 10.1213/XAA.0000000000000270. No abstract available. | |
| 27072772 | Background | Dam M, Hansen CK, Borglum J, Chan V, Bendtsen TF. A transverse oblique approach to the transmuscular Quadratus Lumborum block. Anaesthesia. 2016 May;71(5):603-4. doi: 10.1111/anae.13453. No abstract available. |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D010149 | Pain, Postoperative |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Saline TQL block | Procedure | Unilateral ultrasound-guided TQL block with 30 mL of saline 0,9% 30 min prior to the surgical procedure |
|
| Ropivacaine | Drug |
|
| Saline | Drug |
|
| Ultrasound | Device |
|
| 15 min, 30 min, 1 h, 2h, 4h, 6h, 12h, 18h, 24 hours postoperatively |
| Pain score at sitting position (NRS 0-10/10) | Pain score NRS | 15 min, 30 min, 1 h, 2h, 4h, 6h, 12h, 18h, 24 hours postoperatively |
| Time to first ambulation - get out of bed | Time to first ambulation from bed to walk on the floor | 0-24 hours postoperatively |
| Opioid side effects (nausea, vomiting) | PONV, number of episodes, antiemetics | 0-24 hours postoperatively |
| NRS score during application of the TQL block (NRS 0-10/10) | Procedure discomfort | intraoperative |
| 31153628 | Derived | Dam M, Hansen CK, Poulsen TD, Azawi NH, Wolmarans M, Chan V, Laier GH, Bendtsen TF, Borglum J. Transmuscular quadratus lumborum block for percutaneous nephrolithotomy reduces opioid consumption and speeds ambulation and discharge from hospital: a single centre randomised controlled trial. Br J Anaesth. 2019 Aug;123(2):e350-e358. doi: 10.1016/j.bja.2019.04.054. Epub 2019 May 30. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |