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OpenTrials
Completed

NCT Number: NCT03249168

Duloxetine for Post Laparoscopic Shoulder Pain

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

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Key information

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Medicine, Assiut University

Asyut, 71111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Duloxetine 60mg

Drug

tablet

Placebo

Drug

Tablet

Primary outcomes

  1. post laparoscopic shoulder pain

    Time frame: 12 hours after surgery

    The presence and severity of Post laparoscopic shoulder pain will be recorded using a Visual Analog Scale

Secondary outcomes

  1. sedation

    Time frame: 12 hours after surgery

    Ramsey Sedation Scale

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Preoperative Duloxetine to Prevent Postoperative Shoulder Pain After Gynecological Laparoscopies

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 15, 2017
Registry last updated
Mar 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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