Preemptive Paracetamol for Postoperative Pain

NCT ID: NCT02425254

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Surgical Wound

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Preemptive paracetamol

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

Group Type EXPERIMENTAL

Intravenous paracetamol

Intervention Type DRUG

1000mg intravenous solution for infusion

Intravenous saline 0.9%

Intervention Type DRUG

0.9% sodium chloride in order to ensure double-blinding

Postincision paracetamol

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

Group Type ACTIVE_COMPARATOR

Intravenous paracetamol

Intervention Type DRUG

1000mg intravenous solution for infusion

Intravenous saline 0.9%

Intervention Type DRUG

0.9% sodium chloride in order to ensure double-blinding

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intravenous paracetamol

1000mg intravenous solution for infusion

Intervention Type DRUG

Intravenous saline 0.9%

0.9% sodium chloride in order to ensure double-blinding

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John Williams

Role: PRINCIPAL_INVESTIGATOR

University of Nottiongham

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

John Williams, PhD

Role: CONTACT

01332 724641

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15029

Identifier Type: -

Identifier Source: org_study_id