Duloxetine for Post Laparoscopic Shoulder Pain

Assiut University

Status and phase

Completed

Phase 3

Conditions

Post Laparoscopic Shoulder Pain

Treatments

Drug: Placebo

Drug: Duloxetine 60mg

Study type

Interventional

Funder types

Other

Identifiers

NCT03249168

MFGA

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

Female

Ages

20 to 45 years old

Volunteers

No Healthy Volunteers

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.