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

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
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. -
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
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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