Duloxetine for Post Laparoscopic Shoulder Pain

Phase 3

Completed

• Conditions: Post Laparoscopic Shoulder Pain
• Interventions: Drug: Duloxetine 60mg; Drug: Placebo

• Registration Number: NCT03249168
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2017-07-21
• Study First Submitted QC: 2017-08-10
• Study First Posted: 2017-08-15
• Study Start: 2017-10-01
• Primary Completion: 2018-11-01
• Study Completion: 2019-01-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
case group	Duloxetine 60mg	Duloxetine 60mg orally 12 hours before surgery
Control group	Placebo	Placebo (glucose powder in a tablet) orally 12 hours before surgery

Primary Outcome Measures

Name	Time	Method
post laparoscopic shoulder pain	12 hours after surgery	The presence and severity of Post laparoscopic shoulder pain will be recorded using a Visual Analog Scale

Secondary Outcome Measures

Name	Time	Method
sedation	12 hours after surgery	Ramsey Sedation Scale

Trial Locations

Locations (1)

Faculty of Medicine, Assiut University; 🇪🇬 Assiut, Egypt