Duloxetine for Post Laparoscopic Shoulder Pain

NCT ID: NCT03249168

Last Updated: 2019-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2019-01-01

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.

Conditions

Post Laparoscopic Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

case group

Duloxetine 60mg orally 12 hours before surgery

Group Type: EXPERIMENTAL

Duloxetine 60mg

Intervention Type: DRUG

tablet

Control group

Placebo (glucose powder in a tablet) orally 12 hours before surgery

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Tablet

Interventions

Duloxetine 60mg

tablet

Intervention Type: DRUG

Placebo

Tablet

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

mina fayez ghalyoom

principal invstigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine, Assiut University

Asyut, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 26705527 (View on PubMed)

Study Documents

Document Type: Clinical Study Report

View Document

Other Identifiers

MFGA

Identifier Type: -

Identifier Source: org_study_id