Postoperative Pain, Renal Stones
Conditions
Keywords
Tubeless PCNL, Postoperative Pain, Nephrostomy Tube
Brief summary
Percutaneous nephrolithotomy (PCNL) is the surgery usually done to break down kidney stones that are larger than 1.5 cm. Placing a nephrostomy tube after the surgery to drain urine is a common aspect of traditional PCNL. This tube placement is associated with post-op pain and discomfort. In tubeless PCNL, the nephrostomy tube is not placed, which may lessen pain and speed up recovery. In this randomized controlled trial, the primary objective is to assess the pain and analgesia requirements of patients at different time points after surgery who have undergone a standard PCNL or a tubeless PCNL. Secondary parameters will be recorded, like surgical time, duration of hospital stay, and time interval before the first complaint of pain. Results from this research will offer advice about whether tubeless PCNL can be considered a safe and patient-friendly option as compared to the standard method.
Detailed description
Percutaneous nephrolithotomy (PCNL) is the main surgical option for the management of big kidney stones. Traditionally, a nephrostomy tube is inserted at the end of the operation to allow drainage and provide the opportunity for re-intervention. On the other hand, nephrostomy tubes are believed to cause more postoperative pain and patient discomfort. Tubeless PCNL, which means that the nephrostomy tube is left out while internal drainage is maintained with a ureteral stent, has been suggested as a method to lessen postoperative morbidity. Although more and more studies indicate that it is safe and effective, some people are still not sure because of possible complications, for example, urinary leakage and the need for additional surgery. The research was set up as a prospective randomized controlled trial at a tertiary care hospital. Researchers recruited and randomized sixty (60) patients aged 18 to 80 years with renal stones greater than 1.5 cm into two groups: standard PCNL and tubeless PCNL. The randomization was done using the SNOSE method, which uses sequentially numbered opaque sealed envelopes. General anesthesia was used during all operations. Two consultant urologists who have wide experience in this field performed the operations. While the standard PCNL group ended up with a nephrostomy tube at the end of the operation, the tubeless PCNL group did not get any nephrostomy tube. The main variable was postoperative pain intensity, which was measured on a visual analogue scale (VAS) at 6, 12, and 24 hours. Other variables were operative time, time to first pain complaint, length of hospital stay, and analgesia requirements. The study's goal is to provide information about how well tubeless PCNL can reduce postoperative pain without affecting clinical outcomes compared to standard PCNL, especially in a situation where resources are limited.
Interventions
PROCEDUREStandard Percutaneous Nephrolithotomy (Standard PCNL)
Percutaneous nephrolithotomy (PCNL) is performed with placement of a nephrostomy tube at the end of the procedure.
PROCEDURETubeless Percutaneous Nephrolithotomy (Tubeless PCNL)
Percutaneous nephrolithotomy (PCNL) is performed without placement of a nephrostomy tube at the end of the procedure.
Sponsors
Indus Hospital and Health Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Due to the nature of the surgical intervention, blinding participants, care providers, and outcome assessors was not feasible.
Intervention model description
Two parallel groups of participants were randomly assigned to receive either tubeless percutaneous nephrolithotomy (PCNL) without a nephrostomy tube or standard PCNL with a nephrostomy tube. Outcomes were compared between the two groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 80 years * Renal stones greater than 1.5 cm * Schedule for percutaneous nephrolithotomy (PCNL) * Ability to provide informed consent
Exclusion criteria
* Congenital anatomical renal abnormalities * Known bleeding disorders * Pelvicalyceal system perforation * Refusal or inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone-Free Rate (SFR) | 4 weeks postoperatively | Proportion of patients with no residual renal stones or clinically insignificant fragments (\<4 mm) confirmed on postoperative imaging. |
| Postoperative Pain Score | 6 hours, 12 hours, and 24 hours postoperatively. | Visual Analogue Scale (VAS), a 100 mm scale ranging from 0 mm (no pain) to 100 mm (worst imaginable pain), where higher scores indicate worse pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | During the surgical procedure (from skin incision to completion of procedure) | Total duration of the surgical procedure measured in minutes from skin incision to completion of the procedure. |
| Time to First Pain Complaint | From end of surgery to first reported pain, assessed up to 24 hours postoperatively | Time from completion of surgery to the first reported pain by the patient, measured in hours. |
| Length of Hospital Stay | From admission to discharge, assessed up to 5 days | Total duration of a hospital stay is measured in days from admission to discharge. |
| Analgesia Requirement | From end of surgery up to 24 hours postoperatively | Requirement of rescue analgesia (intravenous Tramadol 50 mg) administered when the Visual Analogue Scale (VAS) score exceeded 43 mm. |
Countries
Pakistan
Outcome results
None listed