NCT02425254

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Jan 2016

Typical duration for phase_4 pain

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

1.4 years

First QC Date

April 9, 2015

Last Update Submit

December 2, 2015

Conditions

PainSurgical Wound

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption

    Measured from PCA machine

    24 hours postoperatively

Secondary Outcomes (11)

  • Time to first analgesic request

    24 hours

  • Nausea and vomiting

    24 hours

  • Pruritus

    24 hours

  • Sedation

    24 hours

  • Urinary retention

    24 hours

  • +6 more secondary outcomes

Study Arms (2)

Preemptive paracetamol

EXPERIMENTAL

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

Drug: Intravenous paracetamolDrug: Intravenous saline 0.9%

Postincision paracetamol

ACTIVE COMPARATOR

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

Drug: Intravenous paracetamolDrug: Intravenous saline 0.9%

Interventions

Intravenous paracetamolDRUG

1000mg intravenous solution for infusion

Postincision paracetamolPreemptive paracetamol
Intravenous saline 0.9%DRUG

0.9% sodium chloride in order to ensure double-blinding

Postincision paracetamolPreemptive paracetamol

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainSurgical Wound

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • John Williams

    University of Nottiongham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John Williams, PhD

CONTACT

01332 724641john.williams7@nottingham.ac.uk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2015

First Posted

April 23, 2015

Study Start

January 1, 2016

Primary Completion

June 1, 2017

Study Completion

July 1, 2018

Last Updated

December 3, 2015

Record last verified: 2015-12