Combination of Duloxetine and Pregabalin to Improve Postoperative Pain

NCT ID: NCT04862845

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-30
• Study Completion Date: 2026-01-01

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Patients in group I (PD group)

Group Type: ACTIVE_COMPARATOR

Duloxetine and Pregabalin

Intervention Type: 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.

patients in group II (P group)

Group Type: ACTIVE_COMPARATOR

pregabalin

Intervention Type: 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.

patients in group III (C groups)

Group Type: SHAM_COMPARATOR

sham

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amr Samir Wahdan

Assistant Professor of anesthesia, SICU & and pain management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

facility of medicine Cairo university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

N-39-2021

Identifier Type: -

Identifier Source: org_study_id