Temporary Application of Abdominal Jackson-Pratt Drain to Reduce Pain After Laparoscopic Surgery in Gynecology (DRAIN-1)
Primary Purpose
Postoperative Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
abdominal Jackson-Pratt drain
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Pain focused on measuring Laparoscopic surgery, Pain, Jackson-Pratt drain
Eligibility Criteria
Inclusion Criteria:
- Patients affected by uterine fibroids, undergoing laparoscopic surgery;
- American Society of Anesthesiologists physical status classification I-II.
Exclusion Criteria:
- inability to express pain;
- any concomitant diseases requiring upper abdominal surgery, such as cholecystectomy or adhesiolysis;
- laparoscopic procedures that were converted to open surgery;
- other causes of known pain;
- oncological cases;
- use of drugs for chronic pelvic pain or hormones in the previous 3 months (wash-out period);
- application of other drainages;
- intra- or post-operative complications.
Sites / Locations
- University of Insubria
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Abdominal Jackson-Pratt drain
Controls
Arm Description
Patients in this arm will undergo one-hour application of abdominal Jackson-Pratt drain at the end of laparoscopic procedure.
Patients in this arm will not undergo one-hour application of abdominal Jackson-Pratt drain at the end of laparoscopic procedure.
Outcomes
Primary Outcome Measures
Pain
Pain perception, expressed as Visual Analogue Score (0-10).
Secondary Outcome Measures
Pain
Pain perception, expressed as Visual Analogue Score (0-10).
Pain
Pain perception, expressed as Visual Analogue Score (0-10).
Use of Analgesic
Number of requests for rescue analgesia (30 mg ketorolac tromethamine, administrated intravenously).
Full Information
NCT ID
NCT03440086
First Posted
February 6, 2018
Last Updated
October 31, 2022
Sponsor
Università degli Studi dell'Insubria
1. Study Identification
Unique Protocol Identification Number
NCT03440086
Brief Title
Temporary Application of Abdominal Jackson-Pratt Drain to Reduce Pain After Laparoscopic Surgery in Gynecology
Acronym
DRAIN-1
Official Title
Evaluation of One-hour Application of Abdominal Jackson-Pratt Drain in Order to Reduce Pain After Laparoscopic Surgery in Gynecology
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2025 (Anticipated)
Primary Completion Date
June 1, 2026 (Anticipated)
Study Completion Date
June 15, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi dell'Insubria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Recent evidence has shown that the onset and intensity of post-operative pain are significantly related to the amount of residual pneumoperitoneum at the end of the surgical procedure. In addition, the use of low pressures of carbon dioxide (CO2) for induction of the pnemoperitoneum has been associated with a reduction in post-operative pain, probably due to a lower abdominal distension and a consequent reduced compression of the pelvic, abdominal and sub-diaphragmatic pain nerve fibers.
The reduction of the residual pnemoperitoneum at the end of the surgical procedure could therefore play a key role in the reduction of post-operative pain, with consequent greater comfort for the patient and reduction of the use of analgesics.
In view of the available evidence, the aim of the present study is to evaluate whether the application of Jackson-Pratt drain, for one hour from the end of the surgical procedure, can significantly reduce post-operative pain and the need of analgesics in patients undergoing laparoscopic gynecological surgery.
Detailed Description
Laparoscopy in gynecological surgery offers numerous advantages, such as the reduction of operative time, intra-operative blood loss, post-operative pain and the possibility of early hospital discharge and return to normal daily activities in a short time.
Despite these points arewidely validated in the literature, sometimes patients undergoing laparoscopy complain of abdominal pains (although slight in intensity and temporary) in the post-operative period. In some cases, the pain is characteristically irradiated at the shoulders, due to a probable irritation/compression of the phrenic nerve that runs on the lower surface of the diaphragm.
Recent evidence has shown that the onset and intensity of post-operative pain are significantly related to the amount of residual pneumoperitoneum at the end of the surgical procedure. In addition, the use of low pressures of carbon dioxide (CO2) for induction of the pnemoperitoneum has been associated with a reduction in post-operative pain, probably due to a lower abdominal distension and a consequent reduced compression of the pelvic, abdominal and sub-diaphragmatic pain nerve fibers.
The reduction of the residual pnemoperitoneum at the end of the surgical procedure could therefore play a key role in the reduction of post-operative pain, with consequent greater comfort for the patient and reduction of the use of analgesics.
In view of the available evidence, the aim of the present study is to evaluate whether the application of Jackson-Pratt drain, for one hour from the end of the surgical procedure, can significantly reduce post-operative pain and the need of analgesics in patients undergoing laparoscopic gynecological surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Laparoscopic surgery, Pain, Jackson-Pratt drain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial (no blinded)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Abdominal Jackson-Pratt drain
Arm Type
Experimental
Arm Description
Patients in this arm will undergo one-hour application of abdominal Jackson-Pratt drain at the end of laparoscopic procedure.
Arm Title
Controls
Arm Type
No Intervention
Arm Description
Patients in this arm will not undergo one-hour application of abdominal Jackson-Pratt drain at the end of laparoscopic procedure.
Intervention Type
Device
Intervention Name(s)
abdominal Jackson-Pratt drain
Intervention Description
One-hour application of abdominal Jackson-Pratt drain at the end of laparoscopic procedure.
Primary Outcome Measure Information:
Title
Pain
Description
Pain perception, expressed as Visual Analogue Score (0-10).
Time Frame
6 hours after surgery.
Secondary Outcome Measure Information:
Title
Pain
Description
Pain perception, expressed as Visual Analogue Score (0-10).
Time Frame
12 hours after surgery.
Title
Pain
Description
Pain perception, expressed as Visual Analogue Score (0-10).
Time Frame
24 hours after surgery.
Title
Use of Analgesic
Description
Number of requests for rescue analgesia (30 mg ketorolac tromethamine, administrated intravenously).
Time Frame
During the 48 hours after surgery.
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients affected by uterine fibroids, undergoing laparoscopic surgery;
American Society of Anesthesiologists physical status classification I-II.
Exclusion Criteria:
inability to express pain;
any concomitant diseases requiring upper abdominal surgery, such as cholecystectomy or adhesiolysis;
laparoscopic procedures that were converted to open surgery;
other causes of known pain;
oncological cases;
use of drugs for chronic pelvic pain or hormones in the previous 3 months (wash-out period);
application of other drainages;
intra- or post-operative complications.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Simone Laganà, M.D.
Phone
3296279579
Email
antoniosimone.lagana@asst-settelaghi.it
Facility Information:
Facility Name
University of Insubria
City
Varese
ZIP/Postal Code
21100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Temporary Application of Abdominal Jackson-Pratt Drain to Reduce Pain After Laparoscopic Surgery in Gynecology
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