Preemptive Paracetamol for Postoperative Pain (PPPP)

December 2, 2015 updated by: University of Nottingham

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Preemptive paracetamol
1000mg intravenous paracetamol given ≥15 minutes before surgical incision and intravenous saline 15 minutes before the end of surgery
Drug: Intravenous paracetamol
1000mg intravenous solution for infusion
Drug: Intravenous saline 0.9%
0.9% sodium chloride in order to ensure double-blinding
ACTIVE_COMPARATOR: Postincision paracetamol
Intravenous saline ≥15 minutes before surgical incision and 1000mg intravenous paracetamol given 15 minutes before the end of surgery
Drug: Intravenous paracetamol
1000mg intravenous solution for infusion
Drug: Intravenous saline 0.9%
0.9% sodium chloride in order to ensure double-blinding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine consumption
Time Frame: 24 hours postoperatively
Measured from PCA machine
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first analgesic request
Time Frame: 24 hours
In minutes
24 hours
Nausea and vomiting
Time Frame: 24 hours
Incidence of nausea or vomiting 24 hours postoperatively
24 hours
Pruritus
Time Frame: 24 hours
Incidence of pruritus 24 hours postoperatively
24 hours
Sedation
Time Frame: 24 hours
Incidence of sedation 24 hours postoperatively
24 hours
Urinary retention
Time Frame: 24 hours
Incidence of urinary retention 24 hours postoperatively
24 hours
Allergic reaction
Time Frame: 24 hours
Incidence of allergic reaction (defined as diagnosed by clinician 24 hours postoperatively)
24 hours
Pain score
Time Frame: 1 hour
Numeric rating scale (NRS)
1 hour
Pain score
Time Frame: 2 hours
Numeric rating scale (NRS)
2 hours
Pain score
Time Frame: 6 hours
Numeric rating scale (NRS)
6 hours
Pain score
Time Frame: 12 hours
Numeric rating scale (NRS)
12 hours
Pain score
Time Frame: 24 hours
Numeric rating scale (NRS)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Investigators

  • Principal Investigator: John Williams, University of Nottiongham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2017

Study Completion (ANTICIPATED)

July 1, 2018

Study Registration Dates

First Submitted

April 9, 2015

First Submitted That Met QC Criteria

April 20, 2015

First Posted (ESTIMATE)

April 23, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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