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Efficacy of Perioperative Duloxetine as a Part of Multimodal Analgesia in Laparoscopic Colorectal Cancer Surgery

A

Assiut University

Status and phase

Unknown
Phase 2

Conditions

Colorectal Cancer

Treatments

Drug: Duloxetine
Drug: Placebo oral tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT04294953
Duloxetine

Details and patient eligibility

About

Our aim will be to evaluate the efficacy of perioperative Duloxetine in decreasing acute postoperative pain after laparoscopic colorectal cancer surgery and its role in reducing postoperative morphine requirements

Full description

Abdominal surgery is usually associated with severe; wide spread post-operative pain. The greater propensity for pain and opioid-related side effects are likely contributing factors for poor postsurgical recovery, and it often results in significant pain and slow recovery. 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 is advocated for perioperative pain management to reduce opioid use and its associated adverse effects. 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.Serotonin and norepinephrine are involved in the modulation of endogenous analgesic mechanisms via descending inhibitory pain pathways in the brain and spinal cord. An increase in serotonin and norepinephrine may increase inhibition of nociceptive input and improve pain relief.

Duloxetine is a serotonin-norepinephrine reuptake inhibitor commonly prescribed for the treatment of major depression and anxiety. Duloxetine also has been used in the treatment of chronic pain conditions. There several reasons why duloxetine might improve postsurgical quality of recovery. First, systemic Duloxetine seems to have perioperative analgesic effects. In addition, as a serotonin-norepinephrine reuptake inhibitor, it is possible that the drug may prevent transient emotional problems that are common during the perioperative period. Lastly, the combination of less pain and better emotional status can result in better physical independence scores after surgery.

The main objective of the current study is to examine the effect of perioperative Duloxetine on postoperative pain after laparoscopic colorectal surgery.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • ASA I-III
  • aged 18-65 years and scheduled for laparoscopic colorectal surgery for cancer colon

Exclusion criteria

  • unable to express their pain or patient refusal.
  • allergy to the study drug
  • an abnormal liver or renal function tests
  • a chronic opioid abuser(> 3 mo), being on chronic gabapentin or pregabalin(> 3 mo)
  • antidepressant drugs, patients with psychiatric disorders
  • Pregnant females

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups, including a placebo group

Group (I) (D) : (Duloxetine group)
Active Comparator group
Treatment:
Drug: Duloxetine
Group (II) (P): (placebo group)
Placebo Comparator group
Treatment:
Drug: Placebo oral tablet

Trial contacts and locations

0

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Central trial contact

Mirna Ismail

Data sourced from clinicaltrials.gov

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