Duloxetine for Post Laparoscopic Shoulder Pain

Post Laparoscopic Shoulder Pain Clinical Trial

Official title:

Preoperative Duloxetine to Prevent Postoperative Shoulder Pain After Gynecological Laparoscopies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03249168
• Other study ID #: MFGA
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: March 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 1, 2019
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Post Laparoscopic Shoulder Pain
• Shoulder Pain

Intervention

Drug:
• Duloxetine 60mg
tablet
• Placebo
Tablet

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	sedation	Ramsey Sedation Scale	12 hours after surgery