search
Back to results

Preemptive Paracetamol for Postoperative Pain (PPPP)

Primary Purpose

Pain, Surgical Wound

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Intravenous paracetamol
Intravenous saline 0.9%
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Preemptive paracetamol

    Postincision paracetamol

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Morphine consumption
    Measured from PCA machine

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 9, 2015
    Last Updated
    December 2, 2015
    Sponsor
    University of Nottingham
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02425254
    Brief Title
    Preemptive Paracetamol for Postoperative Pain
    Acronym
    PPPP
    Official Title
    Preemptive Paracetamol for Postoperative Pain: a Randomised, Double-blind, Two Way Crossover Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    June 2017 (Anticipated)
    Study Completion Date
    July 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Nottingham

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Surgical Wound

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Preemptive paracetamol
    Arm Type
    Experimental
    Arm Description
    1000mg intravenous paracetamol given ≥15 minutes before surgical incision and intravenous saline 15 minutes before the end of surgery
    Arm Title
    Postincision paracetamol
    Arm Type
    Active Comparator
    Arm Description
    Intravenous saline ≥15 minutes before surgical incision and 1000mg intravenous paracetamol given 15 minutes before the end of surgery
    Intervention Type
    Drug
    Intervention Name(s)
    Intravenous paracetamol
    Intervention Description
    1000mg intravenous solution for infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Intravenous saline 0.9%
    Intervention Description
    0.9% sodium chloride in order to ensure double-blinding
    Primary Outcome Measure Information:
    Title
    Morphine consumption
    Description
    Measured from PCA machine
    Time Frame
    24 hours postoperatively
    Secondary Outcome Measure Information:
    Title
    Time to first analgesic request
    Description
    In minutes
    Time Frame
    24 hours
    Title
    Nausea and vomiting
    Description
    Incidence of nausea or vomiting 24 hours postoperatively
    Time Frame
    24 hours
    Title
    Pruritus
    Description
    Incidence of pruritus 24 hours postoperatively
    Time Frame
    24 hours
    Title
    Sedation
    Description
    Incidence of sedation 24 hours postoperatively
    Time Frame
    24 hours
    Title
    Urinary retention
    Description
    Incidence of urinary retention 24 hours postoperatively
    Time Frame
    24 hours
    Title
    Allergic reaction
    Description
    Incidence of allergic reaction (defined as diagnosed by clinician 24 hours postoperatively)
    Time Frame
    24 hours
    Title
    Pain score
    Description
    Numeric rating scale (NRS)
    Time Frame
    1 hour
    Title
    Pain score
    Description
    Numeric rating scale (NRS)
    Time Frame
    2 hours
    Title
    Pain score
    Description
    Numeric rating scale (NRS)
    Time Frame
    6 hours
    Title
    Pain score
    Description
    Numeric rating scale (NRS)
    Time Frame
    12 hours
    Title
    Pain score
    Description
    Numeric rating scale (NRS)
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    John Williams, PhD
    Phone
    01332 724641
    Email
    john.williams7@nottingham.ac.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John Williams
    Organizational Affiliation
    University of Nottiongham
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Preemptive Paracetamol for Postoperative Pain

    We'll reach out to this number within 24 hrs