ibuprofen: Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Morphine Consumption in Lumbar Disc Surgery

Sponsor

Inonu University (Other)

Overall Status

Completed

CT.gov ID

NCT03437707

Collaborator

(none)

Enrollment

Location

Arms

5.9

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Management	Drug: Morphine Sulfate Drug: Intravenous paracetamol Drug: Intravenous ibuprofen	N/A

Detailed Description

All surgical procedures are associated with acute pain and inflammation, with varying degrees of severity for patients, causing significant stress and discomfort. Effective postoperative pain management in lumbar disc surgery may reduce complications and improve postoperative care. For postoperative pain, multimodal analgesic techniques are used to provide synergistic effects through different nociceptive mechanisms.

Various analgesics are used for pain. Opioids, commonly used for postoperative pain, are the most popular drug group. Side effects such as sedation, respiratory depression, nausea-vomiting, pruritus and urinary retention that develop secondary to opioids may also be reduced by the combination of supplemental analgesics.

Adjuvant agents, including nonsteroidal anti-inflammatory drugs (NSAID), may be used in combination with opioids. These drugs not only reduce pain but also control the underlying inflammatory process. In addition, combining NSAIDs and opioids can help to reduce the side effects by minimizing administration of total opioid consumption.

Intravenous (IV) ibuprofen is the first and only IV NSAID approved in the United States for both pain and fever control in adults. It has been reported in multicenter studies that IV ibuprofen is safe and effective in postoperative pain management for abdominal hysterectomy and orthopedic surgeries.

IV paracetamol is an analgesic and antipyretic agent used as a first step drug for pain and fever control in adults and children. It has been clearly shown that IV paracetamol, with analgesic efficacy and good safety profile, reduces analgesic requirements for pain management. It provides better analgesic efficacy and reduces opioid consumption when used in combination with opioids.

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, Randomized, Placebo-Controlled Clinical TrialProspective, Randomized, Placebo-Controlled Clinical Trial

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Morphine Consumption in Lumbar Disc Surgery: Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Actual Study Start Date :

Feb 13, 2018

Actual Primary Completion Date :

Aug 6, 2018

Actual Study Completion Date :

Aug 13, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: placebo 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 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. Other Names: Intravenous patient-controlled analgesia
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 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 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. Other Names: Intravenous patient-controlled analgesia Drug: 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 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. Other Names: paracetamol
Active Comparator: Intravenous ibuprofen 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 Sulfate 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. Other Names: Intravenous patient-controlled analgesia Drug: Intravenous ibuprofen 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. Other Names: ibuprofen

Arm

Intervention/Treatment

Placebo Comparator: placebo

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

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.

Other Names:

Intravenous patient-controlled analgesia

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 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

Other Names:

Intravenous patient-controlled analgesia

Drug: 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 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.

Other Names:

paracetamol

Active Comparator: Intravenous ibuprofen

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 Sulfate

Other Names:

Intravenous patient-controlled analgesia

Drug: Intravenous ibuprofen

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.

Other Names:

ibuprofen

Outcome Measures

Primary Outcome Measures

Postoperative pain scores [From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours]
Visual Analog Scale (VAS, 0-10)

Secondary Outcome Measures

Sedation score [From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours]
Ramsey sedation score (1-6)
Morphine consumption [From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours]
Morphine

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

American Society of Anesthesiologists scores 1-3
18-85 years

Exclusion Criteria:

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