Preemptive Paracetamol for Postoperative Pain | NCT02425254

Studies
Preemptive Paracetamol for Postoperative Pain

NCT02425254

Sponsor

University of Nottingham

Status

Unknown status

Last Update Posted

Dec 3, 2015Estimated

Enrollment

50Estimated

Phase

Phase 4

Conditions

Pain
Surgical Wound

Interventions

Intravenous paracetamol
Intravenous saline 0.9%

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Jun 2017Estimated

Completion Date

Jul 2018Estimated

First Submitted Date

Apr 9, 2015

First Submission Date that Met QC Criteria

Apr 20, 2015

First Posted Date

Apr 23, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2015

Last Update Posted Date

Dec 3, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Preemptive paracetamol	Experimental	1000mg intravenous paracetamol given ≥15 minutes before surgical incision and intravenous saline 15 minutes before the end of surgery	Drug: Intravenous paracetamol Drug: 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 paracetamol Drug: Intravenous saline 0.9%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intravenous paracetamol	Drug	1000mg intravenous solution for infusion	Postincision paracetamol Preemptive paracetamol

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Time to first analgesic request	In minutes	24 hours
Nausea and vomiting	Incidence of nausea or vomiting 24 hours postoperatively

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
John Williams, PhD	Contact	01332 724641		john.williams7@nottingham.ac.uk

Overall Officials

Name	Affiliation	Role
John Williams	University of Nottiongham	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D000072836	Surgical Wound

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided