Preemptive Paracetamol for Postoperative Pain

Pain Clinical Trial

— PPPP  

Official title:

Preemptive Paracetamol for Postoperative Pain: a Randomised, Double-blind, Two Way Crossover Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02425254
• Other study ID #: 15029
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 9, 2015
• Last updated: December 2, 2015
• Start date: January 2016
• Est. completion date: July 2018

Study information

• Verified date: December 2015
• Source: University of Nottingham
• Contact: John Williams, PhD
• Phone: 01332 724641
• Email: john.williams7[@]nottingham.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative
• Surgical Wound

Intervention

Drug:
• Intravenous paracetamol
1000mg intravenous solution for infusion
• Intravenous saline 0.9%
0.9% sodium chloride in order to ensure double-blinding

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption	Measured from PCA machine	24 hours postoperatively	No
Secondary	Time to first analgesic request	In minutes	24 hours	No
Secondary	Nausea and vomiting	Incidence of nausea or vomiting 24 hours postoperatively	24 hours	No
Secondary	Pruritus	Incidence of pruritus 24 hours postoperatively	24 hours	No
Secondary	Sedation	Incidence of sedation 24 hours postoperatively	24 hours	No
Secondary	Urinary retention	Incidence of urinary retention 24 hours postoperatively	24 hours	No
Secondary	Allergic reaction	Incidence of allergic reaction (defined as diagnosed by clinician 24 hours postoperatively)	24 hours	Yes
Secondary	Pain score	Numeric rating scale (NRS)	1 hour	No
Secondary	Pain score	Numeric rating scale (NRS)	2 hours	No
Secondary	Pain score	Numeric rating scale (NRS)	6 hours	No
Secondary	Pain score	Numeric rating scale (NRS)	12 hours	No
Secondary	Pain score	Numeric rating scale (NRS)	24 hours	No