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Duloxetine and Dexamethasone for Improving Postoperative Pain

Primary Purpose

Post Operative Pain Control

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dulox capsule (60mg)
combined Dulox capsule (60 mg) orally and Dex 0.1mg/kg diluted in 100 ml 0.9% NS IVI
a placebo capsule identical to Dulox capsule and 100 ml 0.9% NS IVI over 15 min, as a placebo for dexamethasone
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Pain Control focused on measuring Duloxetine, Dexamethasone, Postoperative pain, side effects.

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

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

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

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

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 11, 2017
    Last Updated
    August 11, 2017
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03250494
    Brief Title
    Duloxetine and Dexamethasone for Improving Postoperative Pain
    Official Title
    Impact of Duloxetine and Dexamethasone for Improving Postoperative Pain After Laparoscopic Gynecological Surgeries: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2014 (Actual)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    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.
    Detailed Description
    This study was designed to be a randomized, placebo-controlled, double-blinded parallel study and this study was carried out at Ain-Shams university hospitals, from December 2014 to January2016, on 75 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. Approval was obtained from the institutional ethical committee and written informed consent was obtained from all patients. Patients were not admitted to the study if any of the following criteria were present: (1) patient's refusal, (2) duration of surgery more than 90 minutes, (3) allergy to any drugs of the study, (4) smokers, history of drug or alcohol abuse, (5) treatment with antidepressants, (6) history of diabetes or epilepsy, (7) , history of chronic pain or daily intake of analgesics within 24 h before surgery, (8) treatment with systemic glucocorticoids within 4 weeks before surgery and (9) impaired kidney or liver functions. Patients were randomly allocated into 3 equal groups, group (I) (GI) (n=25) 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 (Placebo), group (II) (GII) (n=25) 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 and group (III) (GIII) (control group) (n=25) 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. Dulox was presented as CYMBALTA® capsules manufactured by Lilly del Caribe Inc. Imported by Elco and Dex was presented as dexamethasone sulphate ampoules 8mg in 2ml. (Medical Union Pharmaceutical, Egypt MUP). Randomization was done using computer-generated number table of random numbers in a 1:1 ratio and conducted using sequentially numbered, opaque and sealed envelope (SNOSE). Active Dulox capsules were indistinguishable from placebo capsules and placebo capsules contained starch. The study drugs were prepared by the hospital pharmacy and follow-up of patients was conducted by the anesthesia residents not involved in any other part of the study. During the preoperative anesthetic evaluation, patients were familiarized with 10 cm marked visual analogue scale (VAS) for PO assessment of pain, where 0 cm defines no pain and 10 cm defines the maximum intolerable pain. Patients were also assured that they would receive intramuscular injection (IM) of pethidine 0.5 mg / kg once they experienced pain postoperatively (patients with (VAS > 3). The general anesthesia technique was standardized for all the patients as well as monitors including 5 lead ECG, non- invasive blood pressure (NIBP) monitor, pulse oximetry and capnography after intubation using Datascope monitors. Neuromuscular function was monitored using a peripheral nerve stimulator. After establishing an intravenous (IV) line, induction of general anesthesia with fentanyl (2 ug/kg) and sleeping dose of propofol followed by rocuronium (0.6 mg/kg) to facilitate orotracheal intubation was done. Anesthesia was maintained using isoflurane in oxygen and air. Ranitidine (50 mg/ampoule) was given diluted in 10 ml 0.9% sodium chloride solution (NS) slowly (IV) over 10 minutes as a gastroprotective regimen. At the end of the surgery, the residual neuromuscular paralysis was antagonized with neostigmine (0.05 mg/kg) and atropine (0.01 mg/kg). After satisfactory recovery, patients were extubated and transferred to the post-anesthesia care unit (PACU) where they were monitored with ECG, NIBP and pulse oximetry. Assessment of patients' vitals (HR, MAP), arterial SpO2, sedation score, visual analog scale (VAS), the first analgesic requirement time and adverse effects (e.g. nausea, vomiting (PONV), pruritis) were done at 30 minutes, 1h, 2 h, 6h and 12h postoperatively. PO pain was evaluated at rest based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements in 12 hours (mg) postoperatively were recorded. Assessment of sedation was according to sedation score (Ramsay sedation scale) (14). Hypotension was considered if there was 20% decrease below the baseline for MAP and was treated with IV bolus of ephedrine (3-6 mg). Bradycardia was considered if the heart rate < 55 beats/min and was treated with IV atropine (0.01mg/kg). Respiratory depression was defined as a respiratory rate less than 10 breaths/min-1 or peripheral oxygen saturation less than 95% and was treated with oxygen through a transparent face mask and the intermittent doses of IV naloxone (0.4 mg). IV granisetron (1mg) was given in case of vomiting or after 2 successive episodes of nausea. Pruritus was evaluated with a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe or requiring treatment), and patients with severe pruritus were treated with IV clemastine (TavegylR) (2 mg / ampoule). Patient's satisfaction was done by asking the patient to answer the question, 'How would you rate your experience after the surgery?' using a 7-point Likert verbal rating scale (15) and acceptable satisfaction score of the patient being 5-7. Hormonal stress response was assessed through recording plasma cortisol (micrograms / dl) 2 hours postoperatively. Serum cortisol was measured by a Fluorescence Polarization Immunoassay Technology (FPIA) by the Abbott AXSYM system with the following reference ranges (morning serum cortisol 4.2-38.4 ug/dl) and evening serum cortisol 1.7-16.6 ug/dl).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Operative Pain Control
    Keywords
    Duloxetine, Dexamethasone, Postoperative pain, side effects.

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    75 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    group (I) (GI) (n=25)
    Arm Type
    Active Comparator
    Arm Title
    group (II) (GII) (n=25)
    Arm Type
    Active Comparator
    Arm Title
    group (III) (GIII) (control group) (n=25)
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Dulox capsule (60mg)
    Other Intervention Name(s)
    Dulox was presented as CYMBALTA® capsules manufactured by Lilly del Caribe Inc.
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    combined Dulox capsule (60 mg) orally and Dex 0.1mg/kg diluted in 100 ml 0.9% NS IVI
    Other Intervention Name(s)
    Dex was presented as dexamethasone sulphate ampoules 8mg in 2ml. (Medical Union Pharmaceutical, Egypt MUP)
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    a placebo capsule identical to Dulox capsule and 100 ml 0.9% NS IVI over 15 min, as a placebo for dexamethasone
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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.
    Time Frame
    Total pethdine requirements 12h after gynecological surgeries.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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. -

    12. IPD Sharing Statement

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    Duloxetine and Dexamethasone for Improving Postoperative Pain

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