Efficacy of Intravenous Paracetamol and Ibuprofen on Postoperative Pain and Morphine Consumption in Hysterectomy

NCT04691856 | Completed DMC

• 1 other identifier: sedatakbas7
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the effects of intravenous paracetamol and ibuprofen on postoperative pain and morphine consumption in patients undergoing hysterectomy surgery and the side effects associated with opioids.

Conditions

Postoperative Pain Management

Keywords

Postoperative pain; Intravenous paracetamol; Intravenous ibuprofen; Hysterectomy

Outcome Measures

Primary Outcomes (1)

• Postoperative pain scores

  Visual Analog Scale (VAS, 0-10)

  From end of anesthesia (15 minutes after awakening of anesthesia) to postoperative 24-hour period

Secondary Outcomes (2)

• Sedation score

  From end of anesthesia (15 minutes after awakening of anesthesia) to postoperative 24-hour period

• Cumulative morphine consumption (mg)

  From end of anesthesia (15 minutes after awakening of anesthesia) to postoperative 24-hour period

Study Arms (3)

placebo

PLACEBO COMPARATOR

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 Morphine Sulfate with intravenous patient controlled analgesia (IV PCA) pump during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml/h, lockout period: 7 min.

Drug: Morphine Sulfate; Drug: Morphine

Intravenous paracetamol

ACTIVE COMPARATOR

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 Morphine Sulfate with intravenous patient controlled analgesia (IV PCA) pump during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml/h, lockout period: 7 min.

Drug: Morphine Sulfate; Drug: Intravenous paracetamol; Drug: Morphine

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 Morphine Sulfate with intravenous patient controlled analgesia (IV PCA) pump during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml/h, lockout period: 7 min.

Drug: Morphine Sulfate; Drug: Intravenous ibuprofen; Drug: Morphine

Interventions

Morphine Sulfate DRUG

Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.

Also known as: Intravenous patient-controlled analgesia

Intravenous ibuprofen; Intravenous paracetamol; placebo

Intravenous 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 morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.

Also known as: paracetamol

Intravenous paracetamol

Intravenous 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 morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.

Also known as: ibuprofen

Intravenous ibuprofen

Morphine DRUG

All patients were instructed to use intravenous patient-controlled analgesia (IV PCA). All administrations will be applied through IV infusion over 30 minutes. Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.

Intravenous ibuprofen; Intravenous paracetamol; placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Hysterectomy
• 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 65,
• Peptic ulcer disease,
• Hepatic and renal dysfunction,
• Severe cardiovascular and pulmonary disease,
• Allergic history to propofol, fentanyl, rocuronium, paracetamol, ibuprofen and morphine,
• Emergency surgery,
• Refused informed consent form

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Sedat Akbas

Malatya, Türkiye-Türkçe, 44090, 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

Morphine; 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)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Analgesia; Anesthesia and Analgesia; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Sedat MD AKBAS

  Inonu University Medical Faculty

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Model Details: Prospective, Randomized, Placebo-Controlled Clinical Trial

Study Record Dates

• First Submitted: December 24, 2020
• First Posted: December 31, 2020
• Study Start: December 24, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)