Preemptive Paracetamol for Postoperative Pain

Phase 4

• Conditions: Pain; Surgical Wound
• Interventions: Drug: Intravenous paracetamol; Drug: Intravenous saline 0.9%

• Registration Number: NCT02425254
• Lead Sponsor: University of Nottingham

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-09
• Study First Submitted QC: 2015-04-20
• Study First Posted: 2015-04-23
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-03
• Study Start: 2016-01
• Primary Completion: 2017-06
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Preemptive paracetamol	Intravenous paracetamol	1000mg intravenous paracetamol given ≥15 minutes before surgical incision and intravenous saline 15 minutes before the end of surgery
Preemptive paracetamol	Intravenous saline 0.9%	1000mg intravenous paracetamol given ≥15 minutes before surgical incision and intravenous saline 15 minutes before the end of surgery
Postincision paracetamol	Intravenous paracetamol	Intravenous saline ≥15 minutes before surgical incision and 1000mg intravenous paracetamol given 15 minutes before the end of surgery
Postincision paracetamol	Intravenous saline 0.9%	Intravenous saline ≥15 minutes before surgical incision and 1000mg intravenous paracetamol given 15 minutes before the end of surgery

Primary Outcome Measures

Name	Time	Method
Morphine consumption	24 hours postoperatively	Measured from PCA machine

Secondary Outcome Measures

Name	Time	Method
Time to first analgesic request	24 hours	In minutes
Nausea and vomiting	24 hours	Incidence of nausea or vomiting 24 hours postoperatively
Pruritus	24 hours	Incidence of pruritus 24 hours postoperatively
Sedation	24 hours	Incidence of sedation 24 hours postoperatively
Urinary retention	24 hours	Incidence of urinary retention 24 hours postoperatively
Allergic reaction	24 hours	Incidence of allergic reaction (defined as diagnosed by clinician 24 hours postoperatively)
Pain score	24 hours	Numeric rating scale (NRS)