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NCT Number: NCT03440086

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

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Insubria

Varese, 21100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

abdominal Jackson-Pratt drain

Device

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

Primary outcomes

  1. Pain

    Time frame: 6 hours after surgery.

    Pain perception, expressed as Visual Analogue Score (0-10).

Secondary outcomes

  1. Pain

    Time frame: 12 hours after surgery.

    Pain perception, expressed as Visual Analogue Score (0-10).

  2. Pain

    Time frame: 24 hours after surgery.

    Pain perception, expressed as Visual Analogue Score (0-10).

  3. Use of Analgesic

    Time frame: During the 48 hours after surgery.

    Number of requests for rescue analgesia (30 mg ketorolac tromethamine, administrated intravenously).

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Simone Laganà, M.D.

CONTACT

[email protected]

3296279579

Sponsors and collaborators

Lead sponsor

Università degli Studi dell'Insubria

Other

Registry information

Official study title

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

Acronym: DRAIN-1

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 20, 2018
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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