An interventional study of abdominal Jackson-Pratt drain in Postoperative Pain, sponsored by Università degli Studi dell'Insubria. Not yet recruiting at 1 site in Italy. Open to female participants. Per ClinicalTrials.gov, last updated 2022-11-02.
Sponsored by Università degli Studi dell'Insubria · Not applicable, Interventional, and Supportive care
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.
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.
Exclusion Criteria:
Patients in this arm will undergo one-hour application of abdominal Jackson-Pratt drain at the end of laparoscopic procedure.
Device: abdominal Jackson-Pratt drain
Patients in this arm will not undergo one-hour application of abdominal Jackson-Pratt drain at the end of laparoscopic procedure.
One-hour application of abdominal Jackson-Pratt drain at the end of laparoscopic procedure.
Pain
Pain perception, expressed as Visual Analogue Score (0-10).
Time frame: 6 hours after surgery.
Pain
Pain perception, expressed as Visual Analogue Score (0-10).
Time frame: 12 hours after surgery.
Pain
Pain perception, expressed as Visual Analogue Score (0-10).
Time frame: 24 hours after surgery.
Use of Analgesic
Number of requests for rescue analgesia (30 mg ketorolac tromethamine, administrated intravenously).
Time frame: During the 48 hours after surgery.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Università degli Studi dell'Insubria