Duloxetine Potentiates the Analgesic Efficacy of Intrathecal Morphine

NCT ID: NCT03560427

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-10
• Study Completion Date: 2020-03-14

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

duloxetine+morphine

Group Type: EXPERIMENTAL

Duloxetine 60mg

Intervention Type: 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.

placebo+morphine

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Diab Fuad Hetta

lecturer of anesthesia and pain management , Assuit university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diab Hetta, MD

Role: PRINCIPAL_INVESTIGATOR

Lectuere of anesthesia and pain management

Locations

Diab

Asyut, Assuit, Egypt

Countries

Egypt

Other Identifiers

SECI-IRB-IORG0006563-534

Identifier Type: -

Identifier Source: org_study_id