Clinical trial NCT03440086: Temporary Application of Abdominal Jackson-Pratt Drain to Reduce Pain After Laparoscopic Surgery in Gynecology
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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Pain
Keywords: Laparoscopic surgery
Pain
Jackson-Pratt drain
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2018-02-20
Enrollment: 94
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial (no blinded)
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Pain
timeFrame: 6 hours after surgery.
Secondary outcomes:
measure: Pain
timeFrame: 12 hours after surgery.
measure: Pain
timeFrame: 24 hours after surgery.
measure: Use of Analgesic
timeFrame: During the 48 hours after surgery.
Other outcomes:
Locations:
city: Varese
country: Italy
facility: University of Insubria
Study officials:
References: