NCT04294953

Brief Summary

Our aim will be to evaluate the efficacy of perioperative Duloxetine in decreasing acute postoperative pain after laparoscopic colorectal cancer surgery and its role in reducing postoperative morphine requirements

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
60

participants targeted

Target at P50-P75 for phase_2 colorectal-cancer

Timeline
Completed

Started Mar 2020

Shorter than P25 for phase_2 colorectal-cancer

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

February 26, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

February 26, 2020

Last Update Submit

March 3, 2020

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • morphine consumption

    total morphine consumption(mg) in 48 hours if VAS score( Visual Analog Scale ) more than 3. score from 0 to 10 where 0 = no pain and 10 = the worst pain imaginable

    48 hours postoperative

Secondary Outcomes (4)

  • pain scores

    48 hours postoperative

  • first request of analgesia

    48 hours postoperative

  • Postoperative sedation

    48 hours postoperative

  • Postoperative patient satisfaction

    48 hours postoperative

Study Arms (2)

Group (I) (D) : (Duloxetine group)

ACTIVE COMPARATOR
Drug: Duloxetine

Group (II) (P): (placebo group)

PLACEBO COMPARATOR
Drug: Placebo oral tablet

Interventions

DuloxetineDRUG

Each Patient will receive oral Duloxetine capsule 60mg at the night before operation(12hrs before surgery), the 2nd dose 60 mg Duloxetine capsule 1hr before operation and 3rd dose 60mg capsule after 24hrs postoperative

Group (I) (D) : (Duloxetine group)
Placebo oral tabletDRUG

Each patient will receive a similar looking placebo capsule in the same time schedule. The placebo capsule will be prepared by hospital pharmacy to insure that active Duloxetine capsules will be indistinguishable from the placebo capsules contained starch

Group (II) (P): (placebo group)

Eligibility Criteria

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

You may qualify if:

  • ASA I-III
  • aged 18-65 years and scheduled for laparoscopic colorectal surgery for cancer colon

You may not qualify if:

  • unable to express their pain or patient refusal.
  • allergy to the study drug
  • an abnormal liver or renal function tests
  • a chronic opioid abuser(\> 3 mo), being on chronic gabapentin or pregabalin(\> 3 mo)
  • antidepressant drugs, patients with psychiatric disorders
  • Pregnant females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Govil N, Parag K, Arora P, Khandelwal H, Singh A; Ruchi. Perioperative duloxetine as part of a multimodal analgesia regime reduces postoperative pain in lumbar canal stenosis surgery: a randomized, triple blind, and placebo-controlled trial. Korean J Pain. 2020 Jan 1;33(1):40-47. doi: 10.3344/kjp.2020.33.1.40.

    PMID: 31888316BACKGROUND

  • Ho KY, Tay W, Yeo MC, Liu H, Yeo SJ, Chia SL, Lo NN. Duloxetine reduces morphine requirements after knee replacement surgery. Br J Anaesth. 2010 Sep;105(3):371-6. doi: 10.1093/bja/aeq158. Epub 2010 Jun 23.

    PMID: 20573635BACKGROUND

  • Takmaz O, Bastu E, Ozbasli E, Gundogan S, Karabuk E, Kocyigit M, Dede S, Naki M, Kose F, Gungor M. Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy: A Randomized Placebo-Controlled Trial. J Minim Invasive Gynecol. 2020 Mar-Apr;27(3):665-672. doi: 10.1016/j.jmig.2019.04.028. Epub 2019 Aug 30.

    PMID: 31476481BACKGROUND

  • Attia JZ, Mansour HS. Perioperative Duloxetine and Etoricoxibto improve postoperative pain after lumbar Laminectomy: a randomized, double-blind, controlled study. BMC Anesthesiol. 2017 Dec 2;17(1):162. doi: 10.1186/s12871-017-0450-z.

    PMID: 29197345BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Mirna Ismail

CONTACT

01064081717Mirnaismail94@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 26, 2020

First Posted

March 4, 2020

Study Start

March 1, 2020

Primary Completion

March 1, 2021

Study Completion

April 1, 2021

Last Updated

March 4, 2020

Record last verified: 2020-03