Duloxetine for Post Laparoscopic Shoulder Pain
Primary Purpose
Post Laparoscopic Shoulder Pain
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Duloxetine 60mg
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Post 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.
Sites / Locations
- Faculty of Medicine, Assiut University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
case group
Control group
Arm Description
Duloxetine 60mg orally 12 hours before surgery
Placebo (glucose powder in a tablet) orally 12 hours before surgery
Outcomes
Primary Outcome Measures
post laparoscopic shoulder pain
The presence and severity of Post laparoscopic shoulder pain will be recorded using a Visual Analog Scale
Secondary Outcome Measures
sedation
Ramsey Sedation Scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03249168
Brief Title
Duloxetine for Post Laparoscopic Shoulder Pain
Official Title
Preoperative Duloxetine to Prevent Postoperative Shoulder Pain After Gynecological Laparoscopies
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Laparoscopic Shoulder Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
double-blind
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
case group
Arm Type
Experimental
Arm Description
Duloxetine 60mg orally 12 hours before surgery
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Placebo (glucose powder in a tablet) orally 12 hours before surgery
Intervention Type
Drug
Intervention Name(s)
Duloxetine 60mg
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet
Primary Outcome Measure Information:
Title
post laparoscopic shoulder pain
Description
The presence and severity of Post laparoscopic shoulder pain will be recorded using a Visual Analog Scale
Time Frame
12 hours after surgery
Secondary Outcome Measure Information:
Title
sedation
Description
Ramsey Sedation Scale
Time Frame
12 hours after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Faculty of Medicine, Assiut University
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
26705527
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.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.ncbi.nlm.nih.gov/pubmed/26705527
Learn more about this trial
Duloxetine for Post Laparoscopic Shoulder Pain
We'll reach out to this number within 24 hrs