Combination of Duloxetine and Pregabalin to Improve Postoperative Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Duloxetine and Pregabalin; Drug: pregabalin; Drug: sham

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12613
    • facility of medicine Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total morphine consumption by ( mg )	intraoperative and initial 72 postoperative hours morphine consumption mg	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to 1st request of rescue analgesia.	Time to 1st request of rescue analgesia.	24 hours
Postoperative pain score	visual analog scale (VAS) score of pain (0 being 'no pain' and '10' being the maximal worst pain )	24 hous
Postoperative Sedation Score	postoperative sedation score assessed by the Modified Ramsay Sedation Score	24 hous
Patient satisfaction	Patient satisfaction 4-point scale (1 = poor, 2 = fair, 3 = good, 4 = excellent).	72 hours
intraoperative and postoperative complication complications	such as coughing, sedation, anxiety, ataxia, blurred vision, diplopia, nausea and vomiting, shivering, and dizziness was also recorded	72 hours
Quality of Recovery questionnaire	to assess preoperative health status	72 hours

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2021
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): January 1, 2026

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 17, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Amino Acids, Peptides, and Proteins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acids, Acyclic; Carboxylic Acids; Amino Acids; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Thiophenes; Duloxetine Hydrochloride; Pregabalin; salicylhydroxamic acid
• Other Study ID Numbers: N-39-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No