Combination of Duloxetine and Pregabalin to Improve Postoperative Pain

NCT04862845 | Completed Phase 1 DMC

• 1 other identifier: N-39-2021
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• total morphine consumption by ( mg )

  intraoperative and initial 72 postoperative hours morphine consumption mg

  72 hours

Secondary Outcomes (6)

• time to 1st request of rescue analgesia.

  24 hours

• Postoperative pain score

  24 hous

• Postoperative Sedation Score

  24 hous

• Patient satisfaction

  72 hours

• intraoperative and postoperative complication complications

  72 hours

Study Arms (3)

Patients in group I (PD group)

ACTIVE COMPARATOR

Drug: Duloxetine and Pregabalin

patients in group II (P group)

ACTIVE COMPARATOR

Drug: pregabalin

patients in group III (C groups)

SHAM COMPARATOR

Drug: sham

Interventions

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.

patients in group II (P group)

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.

patients in group III (C groups)

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.

Patients in group I (PD group)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

facility of medicine Cairo university

Cairo, 12613, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Duloxetine Hydrochloride; Pregabalin; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of anesthesia, SICU & and pain management

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 28, 2021
• Study Start: July 30, 2021
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

EG (1)