Combination of Duloxetine and Pregabalin to Improve Postoperative Pain
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Duloxetine and Pregabalin
pregabalin
sham
Sponsored by
About this trial
This is an interventional diagnostic trial for Postoperative Pain
Eligibility Criteria
Inclusion criteria:
- Patients aged from 18 to40 years.
- ASA I-II.
- undergoing elective mega -liposuction surgery
BMI from 18 to 50 kg/m2
2. Exclusion criteria:
- Patient refusal
- Contraindication or chronic use (consistent use for longer than 3 months) to any of the study drugs ASA III-IV.
- Patients aged less than 18 or more than 40.
- Body mass index >50.
- Suffered from severe psychiatric disease or drug addiction;
- Chronic opioid consumption,
- a history of regular sedatives or anticonvulsants intake, serious organ disease or dysfunction
- inability to use a PCA device
- History of parenteral or oral analgesic intake within the last 48hours.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Arm Label
Patients in group I (PD group)
patients in group II (P group)
patients in group III (C groups)
Arm Description
Outcomes
Primary Outcome Measures
total morphine consumption by( mg ) over 5 day
Postoperative morphine consumption mg
Secondary Outcome Measures
time to 1st request of rescue analgesia.
Time to 1st request of rescue analgesia.
Postoperative pain score
visual analog scale (VAS) score of pain (0 being 'no pain' and '10' being the maximal worst pain )
total intraoperative fentanyl consumption (microgram) during surgery
fentanyl used
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04862845
Brief Title
Combination of Duloxetine and Pregabalin to Improve Postoperative Pain
Official Title
Effect of Combination of Duloxetine and Pregabalin to Improve Pain After Liposuction Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2021 (Anticipated)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
June 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Postoperative pain is mediated by different mechanisms at multiple neural sites. Thus, multimodal analgesics can reduce the postoperative pain. Although Opioids are considered the analgesics of choice to treat moderate to severe pain, their use carries the risk of side effects and hyperalgesia. Multimodal analgesia can be achieved by combining different analgesics and different methods of administration, to provide better analgesia synergistically compared with conventional analgesia. Therefore,lower doses for each drug can be provided with fewer overall side-effects obtained from individual compounds.
Recently, antidepressants such as duloxetine, a selective serotonin and norepinephrine reuptake inhibitor (SSNRI), have accomplished pain relief in persistent and chronic pain as in fibromyalgia, postherpetic neuralgia, diabetic neuropathy, osteoarthritis and musculoskeletal pain. The analgesic effect of duloxetine is attributed to its ability to enhance both serotonin and norepinephrine neurotransmission in descending inhibitory pain pathways. Moreover, some studies have promoted its use to improve the quality of recovery after surgery and reduce the acute postoperative pain after knee replacement surgery , mastectomy , hysterectomy , and after spine surgery. In addition it can improve postoperative quality of recovery through mood improvement that can be helpful in the postoperative period.
The main objective of the present study was to examine perioperativelythe analgesic efficacy with the combination of duloxetine and prgabalinon postoperative pain when given as part of a multimodal pain strategy in patients undergoing surgery on liosuction. In addition to evaluating the patient's satisfaction and the adverse effects related to the combination of both medications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients in group I (PD group)
Arm Type
Active Comparator
Arm Title
patients in group II (P group)
Arm Type
Active Comparator
Arm Title
patients in group III (C groups)
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
Duloxetine and Pregabalin
Intervention Description
will be received pregabalin with duloxetine 90 minutes preoperatively, then pregabalin every 12 hours with duloxetine once daily postoperatively until the fifth postoperative day.
Intervention Type
Drug
Intervention Name(s)
pregabalin
Intervention Description
received pregabalin with a placebo capsule at 90 minutes preoperatively, then every 12 hours postoperatively with a placebo capsule once daily until the fifth postoperative day.
Intervention Type
Drug
Intervention Name(s)
sham
Intervention Description
received two placebo capsules at 90 minutes preoperatively then placebo capsules every 12 hours, with one capsule daily postoperatively until the fifth postoperative day.
Primary Outcome Measure Information:
Title
total morphine consumption by( mg ) over 5 day
Description
Postoperative morphine consumption mg
Time Frame
5 days
Secondary Outcome Measure Information:
Title
time to 1st request of rescue analgesia.
Description
Time to 1st request of rescue analgesia.
Time Frame
24 hours
Title
Postoperative pain score
Description
visual analog scale (VAS) score of pain (0 being 'no pain' and '10' being the maximal worst pain )
Time Frame
24 hous
Title
total intraoperative fentanyl consumption (microgram) during surgery
Description
fentanyl used
Time Frame
24 hous
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Patients aged from 18 to40 years.
ASA I-II.
undergoing elective mega -liposuction surgery
BMI from 18 to 50 kg/m2
2. Exclusion criteria:
Patient refusal
Contraindication or chronic use (consistent use for longer than 3 months) to any of the study drugs ASA III-IV.
Patients aged less than 18 or more than 40.
Body mass index >50.
Suffered from severe psychiatric disease or drug addiction;
Chronic opioid consumption,
a history of regular sedatives or anticonvulsants intake, serious organ disease or dysfunction
inability to use a PCA device
History of parenteral or oral analgesic intake within the last 48hours.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amr wahdan
Phone
01001422499
Email
amr_amw010@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Combination of Duloxetine and Pregabalin to Improve Postoperative Pain
We'll reach out to this number within 24 hrs