Kidney Cancer Clinical Trial
Official title:
The Benefit of Adding Ultrasound-guided ESP Block to PCA vs. PCA Alone for Postoperative Analgesia After Laparoscopic Nephrectomy Surgeries: a Pilot, Randomized Controlled Trial
NCT number | NCT04085237 |
Other study ID # | 7119 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | January 4, 2020 |
Est. completion date | October 16, 2023 |
Verified date | February 2024 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Nephrectomy (kidney removal) is one of the most common surgical procedures in urologic practice. Recent advances in laparoscopic (keyhole) procedures have resulted in a significant decrease in open nephrectomies. Most laparoscopic surgeries are performed through 3 to 4 small (1 to 1.5 cm) incisions; however, laparoscopic nephrectomies for cancer include one of the incisions being extended to 7 to 10 cm for kidney removal. Although pain after laparoscopic surgery is somewhat less than that after open surgery, it is still significant, and opioid consumption is similar. Opioids have been a mainstay for the treatment of post-operative pain, but they are associated with many adverse effects and a potential for long-term use. Thus, combining opioid analgesia with other forms of analgesia has the potential to reduce opioid use. Paravertebral nerve blocks, where local anesthetic is injected near the spinal nerves, have recently shown good pain control in patients undergoing thoracic and abdominal surgeries. However, this technique is technically challenging, time consuming, and has the risk of significant side effects. Fascial plane blocks are an alternative to paravertebral blocks. Fascial plane blocks, where local anesthetic is injected in areas further away from the spinal nerves, are easier to perform than paravertebral blocks, and have fewer associated risks. A recently described fascial plane block, the Erector Spinae Plane (ESP) block, has been shown to be effective in controlling pain in a variety of surgeries. However, currently, there is little information regarding its use in laparoscopic nephrectomy. We are proposing this pilot randomized control trial to look at the feasibility of completing a larger randomized control trial to evaluate ESP blockade in patients undergoing laparoscopic nephrectomy for cancer. We will also investigate total opioid consumption, and pain scores at rest and during movement.
Status | Terminated |
Enrollment | 10 |
Est. completion date | October 16, 2023 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients requiring laparoscopic nephrectomy and partial nephrectomy for malignancy - Patients of age 18 and over - BMI < 40 - Patients who are expected to stay in-hospital overnight after surgery Exclusion Criteria: - Patient refusal - Contraindications to paravertebral blocks: Infection at the site of needle insertion, empyema, allergy to local anesthetic drugs, and tumor occupying the thoracic paravertebral space, coagulopathy, bleeding disorder or therapeutic anticoagulation - Known allergy to local anesthetics - Inability to provide informed consent - Inability to use a PCA due to languate or comprehension barriers - BMI >= 40 - Any patient on opioids for greater than or equal to 3 months duration prior to surgery - Patients with chronic pain syndromes - Donor nephrectomies due to incision location - Cystic kidney because of very large incisions |
Country | Name | City | State |
---|---|---|---|
Canada | St. Joseph's Healthcare Hamilton | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University | St. Joseph's Healthcare Hamilton |
Canada,
Alper I, Yuksel E. Comparison of Acute and Chronic Pain after Open Nephrectomy versus Laparoscopic Nephrectomy: A Prospective Clinical Trial. Medicine (Baltimore). 2016 Apr;95(16):e3433. doi: 10.1097/MD.0000000000003433. — View Citation
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451. — View Citation
Shah A, Rowlands M, Krishnan N, Patel A, Ott-Young A. Thoracic Intercostal Nerve Blocks Reduce Opioid Consumption and Length of Stay in Patients Undergoing Implant-Based Breast Reconstruction. Plast Reconstr Surg. 2015 Nov;136(5):584e-591e. doi: 10.1097/P — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility - Enrollment rate of greater than one patient per week with 100% in-hospital follow-up | Number of patients recruited per week | One week | |
Secondary | Opioid Consumption | Total long acting opioid consumption in hydromorphone equivalents | 48 hours | |
Secondary | Pain scores at rest and movement | Pain scores will be recorded at intervals. The Numerical Rating Scale (NRS) is an 11-point scale where 0 is no pain and 10 is the worst pain imaginable. | Day 1 | |
Secondary | Number of Adverse Events | Incidence of postoperative nausea-vomiting; respiratory depression; itching; local anesthetic toxicity; catheter leakage and catheter migration; infection at catheter site | Day 1-2 |
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