NCT03437707

Brief Summary

Primary aim of this prospective, randomized, double-blind, placebo-controlled clinical trial is to compare the analgesic effects of IV ibuprofen and paracetamol on postoperative pain, and secondary aim is the effects on morphine consumption and side effects of morphine in patients who underwent lumbar disc surgery with a single level laminectomy or discectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

February 13, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2018

Completed
Last Updated

September 5, 2018

Status Verified

August 1, 2018

Enrollment Period

6 months

First QC Date

February 13, 2018

Last Update Submit

September 3, 2018

Conditions

Postoperative Pain Management

Keywords

Postoperative painIntravenous ibuprofenIntravenous paracetamolLumbar disc 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

  • Morphine consumption

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

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, lockout period: 7 min.

Drug: Morphine Sulfate

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, lockout period: 7 min.

Drug: Morphine SulfateDrug: Intravenous 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 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, lockout period: 7 min.

Drug: Morphine SulfateDrug: Intravenous ibuprofen

Interventions

Morphine SulfateDRUG

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 ibuprofenIntravenous paracetamolplacebo
Intravenous paracetamolDRUG

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 ibuprofenDRUG

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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 morphine,
  • Emergency surgery,
  • Refused informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 23360885RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

MorphineAnalgesia, Patient-ControlledAcetaminophenIbuprofen

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAnalgesiaAnesthesia and AnalgesiaAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Study Officials

  • Sedat AKBAS

    Inonu University Medical Faculty

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, Randomized, Placebo-Controlled Clinical Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

February 13, 2018

First Posted

February 19, 2018

Study Start

February 13, 2018

Primary Completion

August 6, 2018

Study Completion

August 13, 2018

Last Updated

September 5, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)