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NCT Number: NCT04862845

Combination of Duloxetine and Pregabalin to Improve Postoperative Pain

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

facility of medicine Cairo university

Cairo, 12613, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged from 18 to40 years.
  • ASA I-II.
  • undergoing elective mega -liposuction surgery
  • BMI from 18 to 50 kg/m2
  • 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 50.
  • 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.

Treatment and study plan

Duloxetine and Pregabalin

Drug

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

Pregabalin

Drug

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

Drug

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 outcomes

  1. total morphine consumption by ( mg )

    Time frame: 72 hours

    intraoperative and initial 72 postoperative hours morphine consumption mg

Secondary outcomes

  1. time to 1st request of rescue analgesia.

    Time frame: 24 hours

    Time to 1st request of rescue analgesia.

  2. Postoperative pain score

    Time frame: 24 hous

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

  3. Postoperative Sedation Score

    Time frame: 24 hous

    postoperative sedation score assessed by the Modified Ramsay Sedation Score

  4. Patient satisfaction

    Time frame: 72 hours

    Patient satisfaction 4-point scale (1 = poor, 2 = fair, 3 = good, 4 = excellent).

  5. intraoperative and postoperative complication complications

    Time frame: 72 hours

    such as coughing, sedation, anxiety, ataxia, blurred vision, diplopia, nausea and vomiting, shivering, and dizziness was also recorded

  6. Quality of Recovery questionnaire

    Time frame: 72 hours

    to assess preoperative health status

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Combination of Duloxetine and Pregabalin to Improve Pain After Liposuction Surgery

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Apr 28, 2021
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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