Preemptive Paracetamol for Postoperative Pain (PPPP)

University of Nottingham

Status and phase: Unknown; Phase 4

Conditions: Surgical Wound; Pain

Treatments: Drug: Intravenous saline 0.9%; Drug: Intravenous paracetamol

Study type: Interventional

Funder types: Other

Identifiers

NCT02425254

15029

Details and patient eligibility

About

The purpose of this study is to test whether a dose of paracetamol given before surgical incision is more effective at reducing postoperative pain and analgesic consumption in cervical spine surgery versus a dose given at the end of surgery.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18-80 years old
• Patients listed for non-malignant cervical spinal surgery
• General anaesthesia
• Capacity to give informed consent
• Ability to use PCA device and pain score scale
• ASA I, II and III
• >50kg in weight

Exclusion criteria

• Allergy or sensitivity to paracetamol, proparacetamol or morphine
• Liver disease
• Renal disease (creatinine clearance <30ml/min)
• Bleeding disorder
• Chronic alcoholism
• Chronic malnutrition
• Dehydration
• G6PD deficiency
• Hypernatraemia (Na >150)
• Hypokalaemia (K <3.5) and hyperchloraemia
• Pregnancy or breast-feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Preemptive paracetamol

Experimental group

Description:

1000mg intravenous paracetamol given ≥15 minutes before surgical incision and intravenous saline 15 minutes before the end of surgery

Treatment:

Drug: Intravenous saline 0.9%

Drug: Intravenous paracetamol

Postincision paracetamol

Active Comparator group

Description:

Intravenous saline ≥15 minutes before surgical incision and 1000mg intravenous paracetamol given 15 minutes before the end of surgery

Treatment:

Drug: Intravenous saline 0.9%

Drug: Intravenous paracetamol