Postoperative Urinary Retention in Orthopedic Patients
কীওয়ার্ডস
বিমূর্ত
বর্ণনা
This is a randomized clinical trial with simple blinding (the outcome evaluator is blind). Approved by the Ethics and Research Committee of Hospital de Clínicas de Porto Alegre under number 20160043 and Plataforma Brasil CAAE 57623815.1.0000.5327.To calculate the sample size, the program WinPEPI, version 11.43, was used. Considering 80% power, 5% significance level and data reported by Tomaszewski, Balkota and Machowicz (RUPO incidence of 42.86% of the spinal anesthesia group with morphine requiring urinary catheterization and 6.25% in patients undergoing peripheral nerve block ). The sample size found was 26 subjects in each group.
Statistical analysis was performed using SPSS STATISTICS software version 23. Absolute and percentage frequencies were calculated for qualitative variables. And mean, standard deviation and interquartile range for quantitative variables. The normality of the quantitative variables was assessed by the Shapiro-Wilk test. The chi-square test was used to assess the difference in the incidence of catheterization in the two groups and the incidence of nausea and vomiting in 24 hours. To evaluate the difference in the mean time to urination, even after sounding, the Student's t test for independent samples was used. Doses of codeine and morphine at 24 hours and assessment of pain on movement and rest at 12 and 24 hours (by the visual analog scale of pain) were assessed by the Mann Whitney test.
P <0.05 was considered statistically significant. The 52 patients included in the survey were allocated randomly to one of the study groups. Randomization was performed immediately before the interventions studied using the electronic random allocation application Randomizer for Clinical Trial for iPad / iPhone, developed by the company Medsharing (http://www.ecrfmedsharing.com/iphone_ipad_randomization.php).
All patients received spinal anesthesia. The technique included sterile preparation of the puncture site at the L3-L4 or L4-L5 level using Whitacre 27G or 25G needles. Group 1 patients received subarachnoid block with 20 mg of hyperbaric bupivacaine + 200 mcg of morphine and group 2 patients received subarachnoid block with 20 mg of hyperbaric bupivacaine and peripheral nerve block.Peripheral nerve blocks were performed after spinal anesthesia, before the start of the surgical procedure under ultrasound visualization associated with the use of neurostimulator. The choice of the nerve to be blocked was based on the innervation related to analgesia of the surgical site: femoral nerve block or sciatic nerve.
In the post-anesthetic care unit, the following parameters were assessed:
- Need for bladder catheterization;
- Time for spontaneous urination (time in minutes between subarachnoid block and spontaneous urination);
- Presence of pain and the need to use opioids;
- Presence of nausea / vomiting and the need to use antiemetics.
Patients were evaluated at 12 and 24 hours after the surgical procedure for:
- Need for bladder catheterization;
- Time for the first spontaneous urination (with or without previous relief bladder catheter);
- Presence of nausea / vomiting;
- Pain assessment by analogue-visual scale from 0 to 10, at the operated site, at rest and during movement;
- Need to use opioids, noting which opioid and dose used.
The postoperative prescription was standardized:
- Paracetamol 500 mg orally 6/6 hours fixed;
- Dipyrone 1 g intravenous 6/6 hours fixed;
- Codeine 30 mg orally 6/6 hours, if mild to moderate pain using an analogue-visual scale (1 to 6);
- Morphine 3 mg intravenously up to 3/3 hours, if severe pain by analogue-visual scale (7 to 10);
- Ondasentron 4 mg intravenously up to 8/8 hours, if nausea / vomiting is present.
তারিখ
সর্বশেষ যাচাই করা হয়েছে: | 02/29/2020 |
প্রথম জমা দেওয়া: | 02/13/2020 |
আনুমানিক তালিকাভুক্তি জমা দেওয়া হয়েছে: | 03/03/2020 |
প্রথম পোস্ট: | 03/05/2020 |
সর্বশেষ আপডেট জমা দেওয়া হয়েছে: | 03/03/2020 |
সর্বশেষ আপডেট পোস্ট: | 03/05/2020 |
আসল অধ্যয়ন শুরুর তারিখ: | 12/31/2016 |
আনুমানিক প্রাথমিক সমাপ্তির তারিখ: | 07/12/2019 |
আনুমানিক অধ্যয়ন সমাপ্তির তারিখ: | 07/12/2019 |
অবস্থা বা রোগ
হস্তক্ষেপ / চিকিত্সা
Procedure: spinal anesthesia with morphine
Procedure: spinal anesthesia without morphine + peripheral nerve block
পর্যায়
বাহু গ্রুপ
বাহু | হস্তক্ষেপ / চিকিত্সা |
---|---|
Active Comparator: spinal anesthesia with morphine This patients received subarachnoid anesthesia with 20 mg of Hyperbaric Bupivacaine + 200 mcg of Morphine | Procedure: spinal anesthesia with morphine |
Active Comparator: spinal anesthesia without morphine + peripheral nerve block This patients received subarachnoid anesthesia with 20 mg of Hyperbaric Bupivacaine and peripheral nerve block with 0.2 to 0.375% Ropivacaine, in a volume of 20 to 30 mL. | Procedure: spinal anesthesia without morphine + peripheral nerve block |
যোগ্যতার মানদণ্ড
বয়স অধ্যয়নের জন্য যোগ্য | 18 Years প্রতি 18 Years |
লিঙ্গ অধ্যয়নের জন্য যোগ্য | All |
স্বাস্থ্যকর স্বেচ্ছাসেবীদের গ্রহণ করে | হ্যাঁ |
নির্ণায়ক | Inclusion Criteria: - Patients undergoing elective orthopedic surgeries of the lower limbs - Possibility and acceptance of performing the surgical procedure under spinal anesthesia - Minimum hospital stay of 24 hours - Acceptance and signature of the informed consent form Exclusion Criteria: - Subjects who did not understand the Portuguese language - Patients who did not agree with the informed consent term and / or did not sign - Patients with a history of urological problems - Severe cognitive disorders - Patients who were unable to urinate spontaneously before surgery |
ফলাফল
প্রাথমিক ফলাফল ব্যবস্থা
1. Postoperative urinary retention [In 24 hours after surgical procedure]
2. Postoperative urinary retention [In 24 hours after surgical procedure]
মাধ্যমিক ফলাফলের ব্যবস্থা
1. Nausea and vomiting [In 24 hours after surgical procedure]
2. Postoperative pain: Visual Analog Scale (VAS) [In 12 and 24 hours after surgical procedure]
3. Opioid consumption [In the first 24 hours after surgical procedure]