Post Operative Pain Clinical Trial
Official title:
Effectiveness of Different Postoperative Analgesics Use in the Management of Acute Pain After Ureteroscopy.
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.
Status | Recruiting |
Enrollment | 176 |
Est. completion date | December 2022 |
Est. primary completion date | October 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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, |
Country | Name | City | State |
---|---|---|---|
Pakistan | Pakistan Kidney and Liver Institute | Lahore | Punjab |
Lead Sponsor | Collaborator |
---|---|
Pakistan Kidney and Liver Institute and Research Center |
Pakistan,
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. — View 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. — View 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-Naïve 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain score in post op period at 1 hour. | Pain score assessment at one hour by utilizing the Numeric Pain Intensity Scale (NPIS), score will be between 0-10. | [1 hour] | |
Primary | Pain score in post op period at 6 hour. | Pain score assessment at six hour by utilizing the Numeric Pain Intensity Scale (NPIS), score will be between 0-10. | [6 hour] | |
Primary | Pain score in post op period at 12 hour. | Pain score assessment at twelve hour by utilizing the Numeric Pain Intensity Scale (NPIS), score will be between 0-10. | [12 hour] | |
Primary | Pain score in post op period at 24 hour. | Pain score assessment at twenty four hour by utilizing the Numeric Pain Intensity Scale (NPIS), score will be between 0-10. | [24 hour] | |
Primary | Pain score in post op period at 48 hour. | Pain score assessment at forty eight hour by utilizing the Numeric Pain Intensity Scale (NPIS), score will be between 0-10. | [48 hour] | |
Primary | Pain score in post op period at 72 hour. | Pain score assessment at seventy two hour by utilizing the Numeric Pain Intensity Scale (NPIS), score will be between 0-10. | [72 hour] | |
Secondary | Patient Satisfaction | Score on standardized evaluation of patient satisfaction at 7-days post-op. This was on a scale from 1) very dissatisfied to 5) very satisfied. Higher scores are better | First 30 post-operative days | |
Secondary | 4. Emergency visit for pain symptoms by the patients in the postoperative period after the discharge | Number of times patients visited health facility for pain exacerbation | First 30 post-operative days | |
Secondary | Hospital pain killers refill visits of patients for each category of analgesic used | Number of times patients visited health facility for refill pain killers medication | 30 post-operative days |
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