NCT01940224

Brief Summary

The purpose of this study is to evaluate how effective is the preoperative administration of pregabalin 300mg, to attenuate postoperative pain and opioids consumption after laparoscopic colorectal surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 12, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

4.5 years

First QC Date

August 30, 2013

Last Update Submit

February 25, 2019

Conditions

Postoperative Pain

Keywords

PregabalinLaparoscopic colorectal surgeryPostoperative painOpioid consumption

Outcome Measures

Primary Outcomes (1)

  • Postoperative opioid consumption

    The total dose of morphine was calculated as mg and administered by PCA pump. Postoperative morphine requirements were assessed on the arrival of the patient to the recovery room (0hrs),8 hrs,24 hrs until the completion of 48 hours after operation.

    48 hours

Secondary Outcomes (3)

  • Postoperative pain

    48 hours

  • Side- effects

    48 hours

  • Hospital stay

    Participants will be followed for the duration of hospital stay, an expected average of 1 week

Study Arms (2)

Pregabalin & Morphine

ACTIVE COMPARATOR

Administration of pregabalin 300 mg to patients undergo laparoscopic colorectal surgery.Patients receive oral Pregabalin 150 mg the night before surgery, and another one dose of 150 mg 1 hour prior to surgery. Postoperative administration of morphine via PCA pump for 48 hours

Drug: PregabalinDrug: Morphine

Placebo & Morphine

PLACEBO COMPARATOR

Administration of placebo to patients undergo laparoscopic colorectal surgery.Patients receive oral Placebo the night before surgery, and another one dose 1 hour prior to surgery.Postoperative administration of morphine via PCA pump for 48 hours

Drug: PlaceboDrug: Morphine

Interventions

PregabalinDRUG

Preoperative administration of pregabalin 300mg

Also known as: Lyrica
Pregabalin & Morphine
PlaceboDRUG

Preoperative administration of placebo

Placebo & Morphine
MorphineDRUG

Postoperative administration of morphine via PCA pump for 48h

Placebo & MorphinePregabalin & Morphine

Eligibility Criteria

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

You may qualify if:

  • ASA physical status I-III
  • Patients who undergo laparoscopic colectomy for benign or malignant colorectal disease ( \<Τ3 or =T3 tumors without distant metastasis )

You may not qualify if:

  • Contraindication for pneumoperitoneum
  • Contraindication for laparoscopic approach
  • Renal or hepatic insufficiency
  • Alcohol or drugs abuse
  • History of chronic pain or daily intake of analgesics
  • Psychiatric disorders
  • Inability of patients to use PCA pump History of intake of non-steroidal anti-inflammatory drugs the last 24 hours before surgery,use of drainage after the surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Larissa

Larissa, 41100, Greece

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

PregabalinMorphine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Elena Theodorou, MD

    University Hospital of Larissa

    PRINCIPAL INVESTIGATOR

  • George Tzovaras, MD, PhD

    University Hospital of Larissa

    STUDY CHAIR

  • Georgia Stamatiou, MD, PhD

    University Hospital of Larissa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 30, 2013

First Posted

September 12, 2013

Study Start

July 1, 2013

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

GR(1)