Combination of Duloxetine and Pregabalin to Improve Postoperative Pain

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04862845
Collaborator
(none)
72
3
25

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Effect of Combination of Duloxetine and Pregabalin to Improve Pain After Liposuction Surgery
Anticipated Study Start Date :
May 15, 2021
Anticipated Primary Completion Date :
May 15, 2023
Anticipated Study Completion Date :
Jun 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Patients in group I (PD group)

Drug: Duloxetine and Pregabalin
will be received pregabalin with duloxetine 90 minutes preoperatively, then pregabalin every 12 hours with duloxetine once daily postoperatively until the fifth postoperative day.

Active Comparator: patients in group II (P group)

Drug: pregabalin
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.

Sham Comparator: patients in group III (C groups)

Drug: sham
received two placebo capsules at 90 minutes preoperatively then placebo capsules every 12 hours, with one capsule daily postoperatively until the fifth postoperative day.

Outcome Measures

Primary Outcome Measures

  1. total morphine consumption by( mg ) over 5 day [5 days]

    Postoperative morphine consumption mg

Secondary Outcome Measures

  1. time to 1st request of rescue analgesia. [24 hours]

    Time to 1st request of rescue analgesia.

  2. Postoperative pain score [24 hous]

    visual analog scale (VAS) score of pain (0 being 'no pain' and '10' being the maximal worst pain )

  3. total intraoperative fentanyl consumption (microgram) during surgery [24 hous]

    fentanyl used

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion criteria:
  • Patients aged from 18 to40 years.

  • ASA I-II.

  • undergoing elective mega -liposuction surgery

  • BMI from 18 to 50 kg/m2

  1. 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amr Samir Wahdan, lecture of anesthesia, Cairo University
ClinicalTrials.gov Identifier:
NCT04862845
Other Study ID Numbers:
  • NTY-2021
First Posted:
Apr 28, 2021
Last Update Posted:
Apr 28, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2021