Combination of Duloxetine and Pregabalin to Improve Postoperative Pain

Cairo University (CU)

Status and phase: Completed; Phase 1

Conditions: Postoperative Pain

Treatments: Drug: sham; Drug: pregabalin; Drug: Duloxetine and Pregabalin

Study type: Interventional

Funder types: Other

Identifiers

NCT04862845

N-39-2021

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

Patients in group I (PD group)

Active Comparator group

Treatment:

Drug: Duloxetine and Pregabalin

patients in group II (P group)

Active Comparator group

Treatment:

Drug: pregabalin

patients in group III (C groups)

Sham Comparator group

Treatment:

Drug: sham