Duloxetine Potentiates the Analgesic Efficacy of Intrathecal Morphine

NCT03560427 | Completed

• 1 other identifier: SECI-IRB-IORG0006563-534
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• time to first analgesic request

  the time elapsed from (0 hour = immediately postoperative) to time of first demand to analgesic

  48 hours postoperatively

Study Arms (2)

duloxetine+morphine

EXPERIMENTAL

Drug: Duloxetine 60mg

placebo+morphine

PLACEBO COMPARATOR

Drug: placebo

Interventions

Duloxetine 60mg DRUG

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.

duloxetine+morphine

placebo DRUG

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.

placebo+morphine

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients, subjected to major abdominal cancer surgery

You may not qualify if:

• patients on chronic opioid therapy
• patients allergic to study drugs (duloxetine+morphine)
• patients have uncontrolled hypertension and or ischemic heart disease

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Diab

Asyut, Assuit, 71515, Egypt

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Diab Hetta, MD

  Lectuere of anesthesia and pain management

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and pain management , Assuit university

Study Record Dates

• First Submitted: May 19, 2018
• First Posted: June 18, 2018
• Study Start: September 10, 2018
• Primary Completion: March 10, 2020
• Study Completion: March 14, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

EG (1)