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

Postoperative Pain Clinical Trial

— DRAIN-1  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03440086
• Other study ID #: DRAIN-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2025
• Est. completion date: June 15, 2027

Study information

• Verified date: October 2022
• Source: Università degli Studi dell'Insubria
• Contact: Antonio Simone Laganà, M.D.
• Phone: 3296279579
• Email: antoniosimone.lagana[@]asst-settelaghi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 94
• Est. completion date: June 15, 2027
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Italy	University of Insubria	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain perception, expressed as Visual Analogue Score (0-10).	6 hours after surgery.
Secondary	Pain	Pain perception, expressed as Visual Analogue Score (0-10).	12 hours after surgery.
Secondary	Pain	Pain perception, expressed as Visual Analogue Score (0-10).	24 hours after surgery.
Secondary	Use of Analgesic	Number of requests for rescue analgesia (30 mg ketorolac tromethamine, administrated intravenously).	During the 48 hours after surgery.