Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05507554
Other study ID # PKLI Nadeem Iqbal
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2022
Est. completion date December 2022

Study information

Verified date August 2022
Source Pakistan Kidney and Liver Institute and Research Center
Contact Nadeem Iqbal, FCPS*
Phone +92 3345346538
Email dr_nadeemiqbal84@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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,

Study Design


Intervention

Drug:
Opioid
Drug: intravenous injection Tramadol 50 mg and then oral capsule Tramadol 50 mg, once patient starts taking orally. Designated coated 14 days supply of pain medication (oral capsule Tramadol 50 mg) will be given to the patients on discharge. For Pain control oral capsule Tramadol 50 mg is administered 2 times per day until the stent will be removed in clinic 2 weeks later.
Non-Opioid Analgesic
Drug: intravenous injection Paracetamol 1 Gram and then oral Tablet Paracetamol 1 Gram, once patient starts taking orally. Designated coated 14 days supply of pain medication (oral Tablet Paracetamol 1 Gram) will be given to the patients on discharge. For Pain control oral Paracetamol 1 Gram is administered 3 times per day until the stent will be removed in clinic 2 weeks later.
Non-Opioid
Drug: intra muscular injection Diclofenac Sodium 50 mg and then oral Tablet Diclofenac Sodium 50 mg, once patient starts taking orally. Designated coated 14 days supply of pain medication (oral Tablet Diclofenac Sodium 50 mg) will be given to the patients on discharge. For Pain control oral Diclofenac Sodium 50 mg is administered 2 times per day until the stent will be removed in clinic 2 weeks later.

Locations

Country Name City State
Pakistan Pakistan Kidney and Liver Institute Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Pakistan Kidney and Liver Institute and Research Center

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

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

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT05619796 - Assessment of Clinical & Radiographic Efficiency of Manual & Pediatric Rotary Systems in Primary Root Canal Preparation N/A
Recruiting NCT05338671 - Effect of Post-Operative Anesthetics on Post-Operative Pain in Patients Receiving Endodontic Treatment Phase 4
Completed NCT05593341 - Opioid Education in Total Knee Arthroplasty N/A
Completed NCT05584696 - Effectiveness of Green Color Exposure on Dental Anxiety N/A
Not yet recruiting NCT05255146 - Cryoanalgesia and Post-thoracotomy Pain in Minimally Invasive Cardiothoracic Surgery N/A
Not yet recruiting NCT06020196 - The Safety and Efficacy of Surgical Rectus Sheath Block for Postoperative Analgesia After Elective Cesarean Delivery N/A
Completed NCT01697748 - Prospective Study on Cesarean Wound Outcomes N/A
Completed NCT01681966 - A Single-dose Open-Label Study to Assess the Safety and Preliminary Efficacy of PRF 110 in Open Herniorrhaphy Surgery Phase 2
Completed NCT01442818 - Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery N/A
Completed NCT00625911 - Ketamine Improves Post-Thoracotomy Analgesia N/A
Terminated NCT05494125 - Effects of Continuous ESP Catheters on Recovery, Pain and Opioid Consumption After Multilevel Spine Surgery N/A
Recruiting NCT04767399 - Comparison of Postoperative Pain After Instrumentation in Different Visits With Different Single File Systems. N/A
Not yet recruiting NCT05863624 - Open and Endoscopic Technique in Female Inguinal Hernia Repair. FemaleHernia N/A
Completed NCT06048744 - Ultrasound Guided Erector Spinae Plane Block vs External Oblique Intercostal Plane Block for Nephrectomy N/A
Active, not recruiting NCT05374499 - Double-Blinded Randomized Controlled Study Investigating the Efficacy of Exparel (Liposomal Bupivacaine) for Postoperative Pain Relief in Mandibular Third Molar Extractions Phase 4
Completed NCT06082479 - The Effect of Intra Oral Cryotherapy in Patients With Symptomatic Apical Periodontitis N/A
Completed NCT06065683 - Acute Postoperative Pain Prevalence and Intensity in the First 72 Hours
Completed NCT05552391 - Dexametomedine Versus Ketamine as an Adjuvant in Erector Spinae Block for Perioperative Thoracotomy Pain Control Phase 4
Completed NCT05510947 - Acute Postoperative Pain and Catastrophizing in Patients Undergoing Unicompartmental Knee Arthroplasty
Recruiting NCT04909060 - Does the Newborn Infant Parasympathetic Evaluation (NIPE) Index Predict Postsurgical Pain in Children