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Different Postoperative Analgesics Use After Ureteroscopy

Primary Purpose

Post Operative Pain, Ureteroscopy, Ureter Stone

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Opioid
Non-Opioid Analgesic
Non-Opioid
Sponsored by
Pakistan Kidney and Liver Institute and Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring Pain, Analgesics, Non-Steroidal, Opioid, Urolithiasis, Ureteroscopy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • Pakistan Kidney and Liver InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Opioid Group

Paracetamol (Acetaminophen) Group

Diclofenac Sodium Group

Arm Description

This group comprises of patients with ureter stones stones who undergo ureteroscopy procedure. They will be randomized to intravenous injection Tramadol 50 mg. They will also be discharged on Tramadol oral capsule 50 mg for postoperative pain after the ureteroscopy procedure with stent placement

This group comprises of patients with ureter stones stones who undergo ureteroscopy procedure. They will be randomized to intravenous injection Paracetamol 1 Gram. They will also be discharged on oral Tablet Paracetamol 1 Gram for postoperative pain after the ureteroscopy procedure with stent placement

This group comprises of patients with ureter stones stones who undergo ureteroscopy procedure. They will be randomized to intra muscular injection Diclofenac Sodium 50 mg. They will also be discharged on oral Tablet Diclofenac Sodium 50 mg for postoperative pain after the ureteroscopy procedure with stent placement.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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
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
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

Full Information

First Posted
August 17, 2022
Last Updated
August 17, 2022
Sponsor
Pakistan Kidney and Liver Institute and Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT05507554
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pakistan Kidney and Liver Institute and Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Ureteroscopy, Ureter Stone
Keywords
Pain, Analgesics, Non-Steroidal, Opioid, Urolithiasis, Ureteroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Opioid Group
Arm Type
Active Comparator
Arm Description
This group comprises of patients with ureter stones stones who undergo ureteroscopy procedure. They will be randomized to intravenous injection Tramadol 50 mg. They will also be discharged on Tramadol oral capsule 50 mg for postoperative pain after the ureteroscopy procedure with stent placement
Arm Title
Paracetamol (Acetaminophen) Group
Arm Type
Active Comparator
Arm Description
This group comprises of patients with ureter stones stones who undergo ureteroscopy procedure. They will be randomized to intravenous injection Paracetamol 1 Gram. They will also be discharged on oral Tablet Paracetamol 1 Gram for postoperative pain after the ureteroscopy procedure with stent placement
Arm Title
Diclofenac Sodium Group
Arm Type
Active Comparator
Arm Description
This group comprises of patients with ureter stones stones who undergo ureteroscopy procedure. They will be randomized to intra muscular injection Diclofenac Sodium 50 mg. They will also be discharged on oral Tablet Diclofenac Sodium 50 mg for postoperative pain after the ureteroscopy procedure with stent placement.
Intervention Type
Drug
Intervention Name(s)
Opioid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Non-Opioid Analgesic
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Non-Opioid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain score in post op period at 1 hour.
Description
Pain score assessment at one hour by utilizing the Numeric Pain Intensity Scale (NPIS), score will be between 0-10.
Time Frame
[1 hour]
Title
Pain score in post op period at 6 hour.
Description
Pain score assessment at six hour by utilizing the Numeric Pain Intensity Scale (NPIS), score will be between 0-10.
Time Frame
[6 hour]
Title
Pain score in post op period at 12 hour.
Description
Pain score assessment at twelve hour by utilizing the Numeric Pain Intensity Scale (NPIS), score will be between 0-10.
Time Frame
[12 hour]
Title
Pain score in post op period at 24 hour.
Description
Pain score assessment at twenty four hour by utilizing the Numeric Pain Intensity Scale (NPIS), score will be between 0-10.
Time Frame
[24 hour]
Title
Pain score in post op period at 48 hour.
Description
Pain score assessment at forty eight hour by utilizing the Numeric Pain Intensity Scale (NPIS), score will be between 0-10.
Time Frame
[48 hour]
Title
Pain score in post op period at 72 hour.
Description
Pain score assessment at seventy two hour by utilizing the Numeric Pain Intensity Scale (NPIS), score will be between 0-10.
Time Frame
[72 hour]
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
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
Time Frame
First 30 post-operative days
Title
4. Emergency visit for pain symptoms by the patients in the postoperative period after the discharge
Description
Number of times patients visited health facility for pain exacerbation
Time Frame
First 30 post-operative days
Title
Hospital pain killers refill visits of patients for each category of analgesic used
Description
Number of times patients visited health facility for refill pain killers medication
Time Frame
30 post-operative days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ureteroscopy procedure performed for ureteric stones between age 18 -60 years. Patients with normal Renal and Liver function tests function tests. Patients having no growth on urine culture will be included in this study. Patients with no previous history of ureteroscopy procedure in past. Exclusion Criteria: Patients having history of allergic reaction to any type of the drugs to be used in the study. If Paracetamol contraindicated in severe hepatic impairment, or severe active hepatic disease. If Diclofenac contraindicated in compromised renal function, increased risk of bleeding due to clotting disorder, an increased risk of bleeding, gastric ulcers, alcoholism. If tramadol is contraindicated as in alcoholism, depression and drug abuse. When a patient has a history of opioid abuse. When a patient refuses to participate in the study. When patient is unable to give consent. Pregnancy. If the patient has used conventional NSAIDs, Acetaminophen or Tramadol during the 6 hours before surgery,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nadeem Iqbal, FCPS*
Phone
+92 3345346538
Email
dr_nadeemiqbal84@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tanweer Bhatty, FRCS
Phone
+92 3360464991
Email
tanweer.ahmed@pkli.org.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadeem Iqbal, FCPS*
Organizational Affiliation
Pakistan Kidney and Liver Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pakistan Kidney and Liver Institute
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadeem Iqbal, FCPS*
Phone
+92 3345346538
Email
dr_nadeemiqbal84@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30618280
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.
Results Reference
background
PubMed Identifier
30185683
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.
Results Reference
background
PubMed Identifier
29948809
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.
Results Reference
background
PubMed Identifier
34552459
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.
Results Reference
background
PubMed Identifier
31536742
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.
Results Reference
background

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Different Postoperative Analgesics Use After Ureteroscopy

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