Duloxetine for Post Laparoscopic Shoulder Pain
Preoperative Duloxetine to Prevent Postoperative Shoulder Pain After Gynecological Laparoscopies
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2017
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2017
CompletedFirst Posted
Study publicly available on registry
August 15, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedMarch 8, 2019
March 1, 2019
1.1 years
July 21, 2017
March 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
sedation
12 hours after surgery
Study Arms (2)
case group
EXPERIMENTALDuloxetine 60mg orally 12 hours before surgery
Control group
ACTIVE COMPARATORPlacebo (glucose powder in a tablet) orally 12 hours before surgery
Interventions
Eligibility Criteria
You may qualify if:
- Pre-menopausal females
- Patient consent
- Patients with ASA class I-II
- Elective gynecological laparoscopy
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine, Assiut University
Asyut, 71111, Egypt
Related 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.
PMID: 26705527BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- double-blind
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal invstigator
Study Record Dates
First Submitted
July 21, 2017
First Posted
August 15, 2017
Study Start
October 1, 2017
Primary Completion
November 1, 2018
Study Completion
January 1, 2019
Last Updated
March 8, 2019
Record last verified: 2019-03