Duloxetine for Post Laparoscopic Shoulder Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preoperative Duloxetine to Prevent Postoperative Shoulder Pain After Gynecological Laparoscopies

Conditions
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Post Laparoscopic Shoulder Pain

Intervention / Treatment
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* Drug: Duloxetine 60mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 |