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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002130-23 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQL Ropivacaine(active) | Active Comparator | Bilateral Single shot of ropivacaine 0.325% 30 mL. In total 60 mL of 0.325% ropivacaine |
|
| TQL saline (placebo) | Placebo Comparator | Bilateral single shot of saline 0.9% 30 mL. in Total 60 mL of saline 0.9% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | Single shot of ropivacaine 0.325% |
| |
| Measure | Description | Time Frame |
|---|---|---|
| opioid consumption | Opioid consumption postoperatively: data from Patient Controlled Analgesia(PCA) pump and patient medical record). | 12 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| opioid consumption | Opioid consumption postoperatively (data from PCA pump and patient medical record). | 6 hours postoperatively |
| opioid consumption | Opioid consumption postoperatively (data from PCA pump and patient medical record). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zealand university Hospital, Anaesthesiology | Roskilde | 4000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33106280 | Derived | Dam M, Hansen C, Poulsen TD, Azawi NH, Laier GH, Wolmarans M, Chan V, Bendtsen TF, Borglum J. Transmuscular quadratus lumborum block reduces opioid consumption and prolongs time to first opioid demand after laparoscopic nephrectomy. Reg Anesth Pain Med. 2021 Jan;46(1):18-24. doi: 10.1136/rapm-2020-101745. Epub 2020 Oct 26. |
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Double blind placebo Controlled Trial
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Double blind
| Saline |
| Drug |
Single shot of saline 0.9% |
|
| 18 hours postoperatively |
| opioid consumption | Opioid consumption postoperatively (data from PCA pump and patient medical record). | 24 hours postoperatively |
| NRS score | Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain postoperatively at rest and activity | 12 hours postoperatively |
| NRS score at rest and activity | Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain | 6 hours postoperatively |
| NRS score at rest and activity | Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain | 18 hours postoperatively |
| NRS score at rest and activity | Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain | 24 hours postoperatively |
| Opioid-related side effects | The degree of morphine-related side effects (PONV, itching, fatigue, etc.) | 6 hours postoperatively |
| Opioid-related side effects | The degree of morphine-related side effects (PONV, itching, fatigue, etc.) | 12 hours postoperatively |
| Opioid-related side effects | The degree of morphine-related side effects (PONV, itching, fatigue, etc.) | 18 hours postoperatively |
| Opioid-related side effects | The degree of morphine-related side effects (PONV, itching, fatigue, etc.) | 24 hours postoperatively |
| Patient satisfaction with application of the block. NRS | Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain | Immediately after application of the block |
| Ambulation | Time from operation to ambulation | within 24 hours postoperatively |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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