Postoperative Analgesia in Laminectomy ((PAL))

Diskapi Yildirim Beyazit Training and Research Hospital

Status and phase: Unknown; Phase 4

Conditions: Postoperative Pain; Postoperative Laminectomy Pain

Treatments: Drug: 550 mg naproxen sodium and 30mg codeine; Drug: placebo tablet; Drug: 300 mg paracetamol and 30 mg codeine

Study type: Interventional

Funder types: Other

Identifiers

NCT02255955

Pstoperative pain

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 16 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 3 patient groups, including a placebo group

550 mg naproxen sodium and 30mg codeine

Experimental group

Description:

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

Treatment:

Drug: 550 mg naproxen sodium and 30mg codeine

300 mg paracetamol and 30 mg codeine

Active Comparator group

Description:

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

Treatment:

Drug: 300 mg paracetamol and 30 mg codeine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo tablet