Combination of Duloxetine and Pregabalin to Improve Postoperative Pain

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04862845
• Other study ID #: NTY-2021
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 15, 2021
• Est. completion date: June 15, 2023

Study information

• Verified date: April 2021
• Source: Cairo University
• Contact: Amr wahdan
• Phone: 01001422499
• Email: amr_amw010[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: June 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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 40.

• 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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• 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
received two placebo capsules at 90 minutes preoperatively then placebo capsules every 12 hours, with one capsule daily postoperatively until the fifth postoperative day.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total morphine consumption by( mg ) over 5 day	Postoperative morphine consumption mg	5 days
Secondary	time to 1st request of rescue analgesia.	Time to 1st request of rescue analgesia.	24 hours
Secondary	Postoperative pain score	visual analog scale (VAS) score of pain (0 being 'no pain' and '10' being the maximal worst pain )	24 hous
Secondary	total intraoperative fentanyl consumption (microgram) during surgery	fentanyl used	24 hous