Duloxetine and Dexamethasone for Improving Postoperative Pain

NCT03250494 | Completed Phase 4

• 1 other identifier: 17585
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

75 female patients were randomly allocated into one of three equal groups. Group I(GI) received Dulox 60 mg orally and 100 ml 0.9% sodium chloride solution (NS) intravenous infusion (IVI) over 15 min, group II(GII): received combined Dulox capsule 60 mg orally and Dex 0.1mg/kg mixed with 100 ml NS IVI and group III(GIII) received identical placebo duloxetine capsule and 100 ml NS IVI as a placebo for Dex, 2 hours preoperatively. Patients' vitals, VAS and sedation score were assessed at 30 minutes, 1h, 2 h, 6h and 12h postoperatively. Total pethidine requirements, plasma cortisol, PONV and patient's satisfaction were recorded.

Conditions

Post Operative Pain Control

Keywords

Duloxetine, Dexamethasone, Postoperative pain, side effects.

Outcome Measures

Primary Outcomes (1)

• to compare the analgesic efficacy of Dulox alone, with Dulox and Dex combination in reducing postoperative pain measured by total pethdine requirements 12h after gynecological surgeries.

  Total pethdine requirements 12h after gynecological surgeries.

Study Arms (3)

group (I) (GI) (n=25)

ACTIVE COMPARATOR

Drug: Dulox capsule (60mg)

group (II) (GII) (n=25)

ACTIVE COMPARATOR

Drug: combined Dulox capsule (60 mg) orally and Dex 0.1mg/kg diluted in 100 ml 0.9% NS IVI

group (III) (GIII) (control group) (n=25)

PLACEBO COMPARATOR

Drug: a placebo capsule identical to Dulox capsule and 100 ml 0.9% NS IVI over 15 min, as a placebo for dexamethasone

Interventions

Dulox capsule (60mg) DRUG

each patient received Dulox capsule (60mg) orally with sips of water 2 hours preoperatively and 100 ml 0.9% sodium chloride solution (NS) intravenous infusion (IVI) over 15 min

Also known as: Dulox was presented as CYMBALTA® capsules manufactured by Lilly del Caribe Inc.

group (I) (GI) (n=25)

combined Dulox capsule (60 mg) orally and Dex 0.1mg/kg diluted in 100 ml 0.9% NS IVI DRUG

each patient received combined Dulox capsule (60 mg) orally with sips of water and Dex 0.1mg/kg diluted in 100 ml 0.9% NS IVI over 15 min, 2 hours preoperatively

Also known as: Dex was presented as dexamethasone sulphate ampoules 8mg in 2ml. (Medical Union Pharmaceutical, Egypt MUP)

group (II) (GII) (n=25)

a placebo capsule identical to Dulox capsule and 100 ml 0.9% NS IVI over 15 min, as a placebo for dexamethasone DRUG

each patient received a placebo capsule identical to Dulox capsule and 100 ml 0.9% NS IVI over 15 min, as a placebo for dexamethasone 2 hours preoperatively.

group (III) (GIII) (control group) (n=25)

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• female patients aged between 25 and 35 years old of the American Society of Anesthesiologists (ASA) physical status I and II scheduled for elective laparoscopic gynecological surgeries (for infertility) under general anesthesia.

You may not qualify if:

• patient's refusal,
• duration of surgery more than 90 minutes,
• allergy to any drugs of the study,
• smokers, history of drug or alcohol abuse,
• treatment with antidepressants,
• history of diabetes or epilepsy,
• , history of chronic pain or daily intake of analgesics within 24 h before surgery,
• treatment with systemic glucocorticoids within 4 weeks before surgery and (9) impaired kidney or liver functions. -

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Duloxetine Hydrochloride; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: August 15, 2017
• Study Start: December 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: August 15, 2017

Record last verified: 2017-08