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Not yet recruiting NCT03440086

Temporary Application of Abdominal Jackson-Pratt Drain to Reduce Pain After Laparoscopic Surgery in Gynecology

No phase Interventional Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: abdominal Jackson-Pratt drain.
Who it may be relevant to
Registry conditions: Postoperative Pain. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Evaluation of One-hour Application of Abdominal Jackson-Pratt Drain in Order to Reduce Pain After Laparoscopic Surgery in Gynecology

Overview

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.

Interventions

  • Device abdominal Jackson-Pratt drain
    One-hour application of abdominal Jackson-Pratt drain at the end of laparoscopic procedure.

Primary outcome measures

  • Pain [Time frame: 6 hours after surgery.]
Secondary outcome measures (3)
  • Pain [Time frame: 12 hours after surgery.]
  • Pain [Time frame: 24 hours after surgery.]
  • Use of Analgesic [Time frame: During the 48 hours after 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Italy · 1 center
  • University of Insubria — Varese

Identifiers

NCT: NCT03440086 · DRAIN-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗