Postoperative Analgesia in Laminectomy

NCT ID: NCT02255955

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2014-12-31

Brief Summary

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Compare the analgesic effects of naproxen sodium codeine, paracetamol codeine and placebo on postoperative pain and tramadol (Contramal) consumption during the first 24 hour after a lumbar disk surgery.

Detailed Description

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Compare the analgesic effects of naproxen sodium codeine paracetamol codeine and placebo on postoperative pain intensity measured by the visual analogue scale, and evaluated tramadol consumption and related side effects.

Conditions

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Postoperative Pain Postoperative Laminectomy Pain

Keywords

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naproxen sodium codeine paracetamol codeine disk surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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550 mg naproxen sodium and 30mg codeine

Preoperatively patients received oral naproxen sodium codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.

Group Type EXPERIMENTAL

550 mg naproxen sodium and 30mg codeine

Intervention Type DRUG

Postoperative contramal consumption, pain intensity, side effects

300 mg paracetamol and 30 mg codeine

Preoperatively patients received oral paracetamol codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.

Group Type ACTIVE_COMPARATOR

300 mg paracetamol and 30 mg codeine

Intervention Type DRUG

Postoperative contramal consumption, pain intensity, side effects

Placebo

Preoperatively patients received oral placebo tablet, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.

Group Type PLACEBO_COMPARATOR

placebo tablet

Intervention Type DRUG

Postoperative contramal consumption, pain intensity, side effects

Interventions

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550 mg naproxen sodium and 30mg codeine

Postoperative contramal consumption, pain intensity, side effects

Intervention Type DRUG

300 mg paracetamol and 30 mg codeine

Postoperative contramal consumption, pain intensity, side effects

Intervention Type DRUG

placebo tablet

Postoperative contramal consumption, pain intensity, side effects

Intervention Type DRUG

Other Intervention Names

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Apranax plus geralgine K

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists (ASA) 1 or 2 status patients scheduled for an elective lumbar disc surgery

Exclusion Criteria

* were known allergies to any of the drugs used in this study
* peptic ulcer disease
* hepatic and renal dysfunction,
* emergency surgery
* inability to provide informed consent
Minimum Eligible Age

16 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Yildirim Beyazit Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Reyhan Polat

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reyhan Polat, MD

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health

Central Contacts

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Reyhan Polat, MD

Role: CONTACT

Phone: +905326734310

Email: [email protected]

Other Identifiers

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Pstoperative pain

Identifier Type: -

Identifier Source: org_study_id