Clinical trial NCT05507554: Different Postoperative Analgesics Use After Ureteroscopy
Official title: Effectiveness of Different Postoperative Analgesics Use in the Management of Acute Pain After Ureteroscopy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Operative Pain
Ureteroscopy
Ureter Stone
Keywords: Pain
Analgesics
Non-Steroidal
Opioid
Urolithiasis
Ureteroscopy
Lead sponsor: Pakistan Kidney and Liver Institute and Research Center
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, we will see the feasibility of a non-opioid pain killers in management of acute post-operative period as well as on discharge from the hospital compared to opioid medications for postoperative pain following URS and stent placement.

The objective of this study will be to compare the pain control effects of no opioid and opioid pain killers during the post-operative period. This study will be a Randomized Clinical trial. Data will be collected from department of Urology, PKLI, Lahore. All patients included in this study will undergo ureteroscopic laser lithotripsy of ureter stones. One group will receive tramadol (opioid) while other two groups will receive Paracetamol and diclofenac sodium (NSAIDs) respectively. All subjects will receive one of the three pain killers after ureteroscopy procedure for ureter stones in a randomized fashion. Postoperative pain intensity will be measured by the investigator and the nurse in the first hour after the surgery in the recovery room and then in urology ward at 1,6, 12, 24, 48, \& 72 hours using the Numeric Pain Intensity Scale (NPIS).A mean pain score of less than 2 for each category of surgical procedures or analgesics group will be defined as satisfactory pain control. The data will be analyzed using SPSS v 24.

Detailed description: Achieving adequate postoperative pain relief should be a definitive goal of patient care in any surgery because pain is one of the most common postoperative symptoms as reported from previous studies. Efforts have begun to implement non opioid protocols for outpatient urologic surgery. Recently it was found that Ureteroscopy (URS) with stent placement is possible without using postoperatve opioids for pain control and stent-related symptoms. To date, attention has focused on the problems of opioid abuse, diversion, and overdose. These issues pertain primarily to those who are already suffering from substance use disorders. More recently, the possibility that legitimate use of prescription opioids has led to incident substance use disorders (iatrogenic addiction) is beginning to gather attention.

When iatrogenic addiction has been considered, it is almost exclusively in the context of chronic pain. Not surprisingly, emergency providers commonly believe that short courses of opioid therapy for acute pain are safe and that their role in the current opioid crisis is limited to attenuating diversion. However, several recent studies have demonstrated that short course opioid therapy for acute pain is associated with future recurrent use of opioids, raising the possibility that short course opioid therapy may be a potential trigger for the onset of opioid related substance use disorders. If so, there are considerable health implications as more than 1 in every 6 patients discharged from an ED are given a prescription for an opioid pain reliever.

In this study, we will see the feasibility of a non-opioid discharge protocol compared to standard opioid medications for postoperative pain following URS and stent placement. We will also evaluate the effect of these analgesic in acute pain management in post op stay in hospital.

Eligibility criteria: Inclusion Criteria:

1. Ureteroscopy procedure performed for ureteric stones between age 18 -60 years.
2. Patients with normal Renal and Liver function tests function tests.
3. Patients having no growth on urine culture will be included in this study.
4. Patients with no previous history of ureteroscopy procedure in past.

Exclusion Criteria:

1. Patients having history of allergic reaction to any type of the drugs to be used in the study.
2. If Paracetamol contraindicated in severe hepatic impairment, or severe active hepatic disease.
3. If Diclofenac contraindicated in compromised renal function, increased risk of bleeding due to clotting disorder, an increased risk of bleeding, gastric ulcers, alcoholism.
4. If tramadol is contraindicated as in alcoholism, depression and drug abuse.
5. When a patient has a history of opioid abuse.
6. When a patient refuses to participate in the study.
7. When patient is unable to give consent.
8. Pregnancy.
9. If the patient has used conventional NSAIDs, Acetaminophen or Tramadol during the 6 hours before surgery,

Primary outcomes:
measure: Pain score in post op period at 1 hour.
timeFrame: [1 hour]
measure: Pain score in post op period at 6 hour.
timeFrame: [6 hour]
measure: Pain score in post op period at 12 hour.
timeFrame: [12 hour]
measure: Pain score in post op period at 24 hour.
timeFrame: [24 hour]
measure: Pain score in post op period at 48 hour.
timeFrame: [48 hour]
measure: Pain score in post op period at 72 hour.
timeFrame: [72 hour]
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: First 30 post-operative days
measure: 4. Emergency visit for pain symptoms by the patients in the postoperative period after the discharge
timeFrame: First 30 post-operative days
measure: Hospital pain killers refill visits of patients for each category of analgesic used
timeFrame: 30 post-operative days
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Pakistan Kidney and Liver Institute
state: Punjab
Study officials:
affiliation: Pakistan Kidney and Liver Institute
name: Nadeem Iqbal, FCPS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kang C, Shu X, Herrell SD, Miller NL, Hsi RS. Opiate Exposure and Predictors of Increased Opiate Use After Ureteroscopy. J Endourol. 2019 Jun;33(6):480-485. doi: 10.1089/end.2018.0796. Epub 2019 Feb 8.
citation: Salaudeen GO, Afuwape OO, Eyelade OR, Olapade-Olaopa EO. Effectiveness of postoperative analgesia in the management of acute pain in day-case surgeries. Ann Afr Med. 2018 Jul-Sep;17(3):140-144. doi: 10.4103/aam.aam_53_17.
citation: Klueh MP, Hu HM, Howard RA, Vu JV, Harbaugh CM, Lagisetty PA, Brummett CM, Englesbe MJ, Waljee JF, Lee JS. Transitions of Care for Postoperative Opioid Prescribing in Previously Opioid-Naive Patients in the USA: a Retrospective Review. J Gen Intern Med. 2018 Oct;33(10):1685-1691. doi: 10.1007/s11606-018-4463-1. Epub 2018 Jun 11.
citation: Kasman AM, Schmidt B, Spradling K, Chow C, Hunt R, Wu M, Sockol A, Liao J, Leppert JT, Shah J, Conti SL. Postoperative opioid-free ureteroscopy discharge: A quality initiative pilot protocol. Curr Urol. 2021 Sep;15(3):176-180. doi: 10.1097/CU9.0000000000000025. Epub 2021 May 26.
citation: Tam CA, Dauw CA, Ghani KR, Gunaseelan V, Kim T, Leavitt DA, Raisky J, Yan PL, Hollingsworth JM. New Persistent Opioid Use After Outpatient Ureteroscopy for Upper Tract Stone Treatment. Urology. 2019 Dec;134:103-108. doi: 10.1016/j.urology.2019.08.042. Epub 2019 Sep 16.