Different Postoperative Analgesics Use After Ureteroscopy

NCT05507554 | Unknown

• 1 other identifier: PKLI Nadeem Iqbal
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain; Ureteroscopy; Ureter Stone

Keywords

Pain; Analgesics; Non-Steroidal; Opioid; Urolithiasis; Ureteroscopy

Outcome Measures

Primary Outcomes (6)

• 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]

• 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]

• 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]

• 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]

• 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]

• 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 Outcomes (3)

• Patient Satisfaction

  First 30 post-operative days

• 4. Emergency visit for pain symptoms by the patients in the postoperative period after the discharge

  First 30 post-operative days

• Hospital pain killers refill visits of patients for each category of analgesic used

  30 post-operative days

Study Arms (3)

Opioid Group

ACTIVE COMPARATOR

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

Drug: Opioid

Paracetamol (Acetaminophen) Group

ACTIVE COMPARATOR

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

Drug: Non-Opioid Analgesic

Diclofenac Sodium Group

ACTIVE COMPARATOR

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.

Drug: Non-Opioid

Interventions

Opioid DRUG

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.

Opioid Group

Non-Opioid Analgesic DRUG

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.

Paracetamol (Acetaminophen) Group

Non-Opioid DRUG

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.

Diclofenac Sodium Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Pakistan Kidney and Liver Institute and Research Center: lead

Study Sites (1)

Pakistan Kidney and Liver Institute

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related 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.

  PMID: 30618280 BACKGROUND

• 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.

  PMID: 30185683 BACKGROUND

• 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.

  PMID: 29948809 BACKGROUND

• 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.

  PMID: 34552459 BACKGROUND

• 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.

  PMID: 31536742 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Ureterolithiasis; Pain; Urolithiasis

Interventions

Analgesics, Opioid; Analgesics, Non-Narcotic

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Nadeem Iqbal, FCPS*

  Pakistan Kidney and Liver Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadeem Iqbal, FCPS*

CONTACT

+92 3345346538; dr_nadeemiqbal84@yahoo.com

Tanweer Bhatty, FRCS

CONTACT

+92 3360464991; tanweer.ahmed@pkli.org.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 19, 2022
• Study Start: August 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)