Duloxetine for Post Laparoscopic Shoulder Pain

Preoperative Duloxetine to Prevent Postoperative Shoulder Pain After Gynecological Laparoscopies

Despite recent advances in minimal invasive surgery, postoperative pain control remains a challenge for both surgeons and anesthesiologists . Currently, laparoscopy has an obvious favor for both diagnostic and therapeutic procedures of pelvic and abdomen; while it is minimally invasive, has less pain, and needs less postoperative analgesic use compared with open surgeries . Shoulder pain is a frequent problem following laparoscopic procedure

Study Overview

• Status: Completed
• Conditions: Post Laparoscopic Shoulder Pain
• Intervention / Treatment: Drug: Placebo; Drug: Duloxetine 60mg

Detailed Description

Many patients may feel much more discomfort from their shoulder pain than incision pain . Post laparoscopic shoulder pain is caused by irritation and/or injury of the diaphragm and phrenic nerve by local acidosis and irritative effect of carbon dioxide during pneumoperitoneum or distention forces on the diaphragm. Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor antidepressant . It is used to treat major depressive disorder in adults. Duloxetine is also used to treat general anxiety disorder. It is also used in adults to treat fibromyalgia (a chronic pain disorder), or chronic muscle or joint pain (such as low back pain and osteoarthritis pain). Duloxetine is also used to treat diabetic neuropathy. Previous studies focused on the use of gabapentin and pregabalin (both are antineuropathic pain medications) to prevent post laparoscopic shoulder pain after laparoscopic ovarian cystectomy and laparoscopic cholecystectomy showed favorable results and since duloxetine is an antineuropathic pain medications we assume its use will ameliorate diaphragmatic irritation and hencepost laparoscopic shoulder pain.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Faculty of Medicine, Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pre-menopausal females
• Patient consent
• Patients with ASA class I-II
• Elective gynecological laparoscopy

Exclusion Criteria:

• Body Mass Index ≥ 40
• Consuming any pain killers routinely within 48 hours before the surgery
• Smoking, drug abuse
• Patients with major psychiatric disorders, epilepsy or history of convulsion
• Any known kidney or hepatic disorders
• History of any other pervious laparotomy, laparoscopy, or other pelvic manipulation or pathology except normal vaginal delivery
• History of chest or mediastinal surgery or pathology
• Recent flu (six weeks before surgery)
• Suspected to malignancy as pathology
• Those who complained from shoulder pain just before surgery in the first Visual Analog Scale assessment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: case group; Duloxetine 60mg orally 12 hours before surgery	Drug: Duloxetine 60mg; tablet
Active Comparator: Control group; Placebo (glucose powder in a tablet) orally 12 hours before surgery	Drug: Placebo; Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post laparoscopic shoulder pain	The presence and severity of Post laparoscopic shoulder pain will be recorded using a Visual Analog Scale	12 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sedation	Ramsey Sedation Scale	12 hours after surgery

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Valadan M, Banifatemi S, Yousefshahi F. Preoperative Gabapentin to Prevent Postoperative Shoulder Pain After Laparoscopic Ovarian Cystectomy: A Randomized Clinical Trial. Anesth Pain Med. 2015 Dec 5;5(6):e31524. doi: 10.5812/aapm.31524. eCollection 2015 Dec.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: July 21, 2017
• First Submitted That Met QC Criteria: August 10, 2017
• First Posted (Actual): August 15, 2017

Study Record Updates

• Last Update Posted (Actual): March 8, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Duloxetine Hydrochloride
• Other Study ID Numbers: MFGA

Plan for Individual participant data (IPD)

Study Data/Documents

1. Clinical Study Report

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No