Clinical trial NCT03249168: Duloxetine for Post Laparoscopic Shoulder Pain
Official title: Preoperative Duloxetine to Prevent Postoperative Shoulder Pain After Gynecological Laparoscopies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post Laparoscopic Shoulder Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: post laparoscopic shoulder pain
timeFrame: 12 hours after surgery
Secondary outcomes:
measure: sedation
timeFrame: 12 hours after surgery
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine, Assiut University
Study officials:
References:
citation: 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.