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

Phase 2

• Conditions: Colorectal Cancer
• Interventions: Drug: Duloxetine; Drug: Placebo oral tablet

• Registration Number: NCT04294953
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-02-26
• Status Verified: 2020-03
• Study Start: 2020-03-01
• Study First Submitted QC: 2020-03-03
• Last Update Submitted: 2020-03-03
• Study First Posted: 2020-03-04
• Last Update Posted: 2020-03-04
• Primary Completion: 2021-03-01
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group (I) (D) : (Duloxetine group)	Duloxetine	-
Group (II) (P): (placebo group)	Placebo oral tablet	-

Primary Outcome Measures

Name	Time	Method
morphine consumption	48 hours postoperative	total morphine consumption(mg) in 48 hours if VAS score( Visual Analog Scale ) more than 3. score from 0 to 10 where 0 = no pain and 10 = the worst pain imaginable

Secondary Outcome Measures

Name	Time	Method
pain scores	48 hours postoperative	- pain scores ( theVAS score ).evaluation the pain using VAS ( Visual Analog Scale ) scored from 0 to 10 where 0 = no pain and 10 = the worst pain imaginable
first request of analgesia	48 hours postoperative	- the time of first request of analgesia (morphine) requirement postoperative
Postoperative sedation	48 hours postoperative	Postoperative sedation will be assessed using a modified observers. Assessment of alterness /sedation scale where 6= agitated to 0 = doesn't respond to deep stimulus.
Postoperative patient satisfaction	48 hours postoperative	Postoperative patient satisfaction will be measured using a numerical score of 1-4 (1= poor, 2= fair, 3= good, 4= very good) .