Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Tramadol Consumption in Shoulder Surgery

NCT05401916 | Completed DMC

• 1 other identifier: muhittincalim2
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Primary aim of this prospective, randomized, double-blind clinical trial is to compare the analgesic effects of intravenous paracetamol and ibuprofen on postoperative pain, and secondary aim is the effects on tramadol consumption and side effects of tramadol in patients who underwent unilateral shoulder surgery.

Conditions

Postoperative Pain Management

Keywords

Postoperative pain; Intravenous ibuprofen; Intravenous paracetamol; Shoulder surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative pain scores

  Visual Analog Scale (VAS, 0-10)

  From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours

Secondary Outcomes (2)

• Sedation score

  From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours

• Tramadol consumption

  From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours

Study Arms (2)

Intravenous paracetamol

ACTIVE COMPARATOR

Intravenous paracetamol 1 g paracetamol will be administered 30 minutes before the end of surgery. All administrations will be applied through IV infusion over 30 minutes. Patients will be received Tramadol with intravenous patient controlled analgesia (IV PCA) pump during postoperative 24 hours. The PCA solution will be prepared with 500 mg tramadol in 100 mL of saline (5 mg/ml). The PCA device was adjusted as infusion: 2 ml/h, bolus: 2 ml, lockout period: 15 min.

Drug: Tramadol; Drug: Paracetamol

Intravenous ibuprofen

ACTIVE COMPARATOR

800 mg ibuprofen (diluted with 250 ml saline) will be administered 30 minutes before the end of surgery. All administrations will be applied through IV infusion over 30 minutes. Patients will be received Tramadol with intravenous patient controlled analgesia (IV PCA) pump during postoperative 24 hours. The PCA solution will be prepared with 500 mg tramadol in 100 mL of saline (5 mg/ml). The PCA device was adjusted as infusion: 2 ml/h, bolus: 2 ml, lockout period: 15 min.

Drug: Tramadol; Drug: Ibuprofen

Interventions

Tramadol DRUG

Patients will be received tramadol with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 500 mg tramadol in 100 mL of saline (5 mg/ml). The PCA device was adjusted as infusion: 2 ml/h, bolus: 2 ml, lockout period: 15 min.

Also known as: Intravenous patient-controlled analgesia

Intravenous ibuprofen; Intravenous paracetamol

Paracetamol DRUG

1 g paracetamol will be administered 30 minutes before the end of surgery. All administrations will be applied through IV infusion over 30 minutes. Patients will be received tramadol with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 500 mg tramadol in 100 mL of saline (5 mg/ml). The PCA device was adjusted as infusion: 2 ml/h, bolus: 2 ml, lockout period: 15 min.

Also known as: Intravenous paracetamol

Intravenous paracetamol

Ibuprofen DRUG

800 mg ibuprofen (diluted with 250 ml saline) will be administered 30 minutes before the end of surgery. All administrations will be applied through IV infusion over 30 minutes. Patients will be received tramadol with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 500 mg tramadol in 100 mL of saline (5 mg/ml). The PCA device was adjusted as infusion: 2 ml/h, bolus: 2 ml, lockout period: 15 min.

Also known as: Intravenous ibuprofen

Intravenous ibuprofen

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists scores 1-3
• years

You may not qualify if:

• American Society of Anesthesiologists scores IV,
• Under the age of 18,
• Over the age of 85,
• Peptic ulcer disease,
• Hepatic and renal dysfunction,
• Severe cardiovascular and pulmonary disease,
• Allergic history to propofol, fentanyl, rocuronium, paracetamol, ibuprofen and tramadol,
• Emergency surgery

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Muhittin Calim

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (1)

• Tunali Y, Akcil EF, Dilmen OK, Tutuncu AC, Koksal GM, Akbas S, Vehid H, Yentur E. Efficacy of intravenous paracetamol and dexketoprofen on postoperative pain and morphine consumption after a lumbar disk surgery. J Neurosurg Anesthesiol. 2013 Apr;25(2):143-7. doi: 10.1097/ANA.0b013e31827464af.

  PMID: 23360885 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tramadol; Analgesia, Patient-Controlled; Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Analgesia; Anesthesia and Analgesia; Acetanilides; Anilides; Amides; Aniline Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Muhittin MD Calim

  Bezmialem Vakif University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, Randomized Double Blind Clinical Trial

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 2, 2022
• Study Start: June 10, 2022
• Primary Completion: March 9, 2023
• Study Completion: April 9, 2023
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)