Duloxetine Potentiates the Analgesic Efficacy of Intrathecal Morphine

Acute Pain Clinical Trial

Official title:

Duloxetine Potentiates the Analgesic Efficacy of Intrathecal Morphine in Major Abdominal Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03560427
• Other study ID #: SECI-IRB-IORG0006563-534
• Status: Completed
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: March 14, 2020

Study information

• Verified date: March 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Duloxetine is a serotonin-norepinephrine reuptake inhibitor primarily used for treatment of major depression and anxiety. Duloxetine also has been used in the treatment of chronic pain conditions, such as osteoarthritis and musculoskeletal pain. There are few studies examining its effect for acute pain. The objective of this study is to evaluate the analgesic effect of duloxetine combined with intrathecal morphine for patients subjected to major abdominal cancer surgery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 14, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

Inclusion Criteria:

• adult patients, subjected to major abdominal cancer surgery

Exclusion Criteria:

• patients on chronic opioid therapy

• patients allergic to study drugs (duloxetine+morphine)

• patients have uncontrolled hypertension and or ischemic heart disease

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Duloxetine 60mg
Patients will receive duloxetine, 60 mg tablet 2 hour before operation and will be anesthetized by combined spinal-general anesthesia that includes: spinal anesthesia with morphine 0.3 mg delivered in L4-5 inter spinous space. General anethseia: Induction of anesthesia was done by intravenous fentanyl, 2 µg / kg and propofol 1 - 2 mg / kg. Endotracheal intubation was achieved by cis-atracurium, 0.15 mg / kg. Maintenance of anesthesia was done by isoflurane and cis-atracurium, 0.03 mg / kg on demand. Additional intraoperative analgesia was consisted of administration of intravenous boluses of fentanyl, 50 µg according to the attending anesthesiologist's decision. At the end of surgery, muscle relaxation was reversed using neostigmine 0.05 mg / kg and atropine 0.01 mg / kg.
• placebo
Patients will receive placebo tablet 2 hour before operation and will be anesthetized by combined spinal-general anesthesia that includes: spinal anesthesia with morphine 0.3 mg delivered in L4-5 inter spinous space. General anethseia: Induction of anesthesia was done by intravenous fentanyl, 2 µg / kg and propofol 1 - 2 mg / kg. Endotracheal intubation was achieved by cis-atracurium, 0.15 mg / kg. Maintenance of anesthesia was done by isoflurane and cis-atracurium, 0.03 mg / kg on demand. Additional intraoperative analgesia was consisted of administration of intravenous boluses of fentanyl, 50 µg according to the attending anesthesiologist's decision. At the end of surgery, muscle relaxation was reversed using neostigmine 0.05 mg / kg and atropine 0.01 mg / kg.

Locations

Country	Name	City	State
Egypt	Diab	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to first analgesic request	the time elapsed from (0 hour = immediately postoperative) to time of first demand to analgesic	48 hours postoperatively