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

NCT03440086 | Not Yet Recruiting DMC

• 1 other identifier: DRAIN-1
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Laparoscopic surgery; Pain; Jackson-Pratt drain

Outcome Measures

Primary Outcomes (1)

• Pain

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

  6 hours after surgery.

Secondary Outcomes (3)

• Pain

  12 hours after surgery.

• Pain

  24 hours after surgery.

• Use of Analgesic

  During the 48 hours after surgery.

Study Arms (2)

Abdominal Jackson-Pratt drain

EXPERIMENTAL

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

Controls

NO INTERVENTION

Patients in this arm will not undergo one-hour application of abdominal Jackson-Pratt drain at the end of laparoscopic procedure.

Interventions

abdominal Jackson-Pratt drain DEVICE

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

Abdominal Jackson-Pratt drain

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients affected by uterine fibroids, undergoing laparoscopic surgery;
• American Society of Anesthesiologists physical status classification I-II.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

Study Sites (1)

University of Insubria

Varese, 21100, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Antonio Simone Laganà, M.D.

CONTACT

3296279579; antoniosimone.lagana@asst-settelaghi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Randomized controlled trial (no blinded)

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 20, 2018
• Study Start: June 1, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): June 15, 2027
• Last Updated: November 2, 2022

Record last verified: 2022-10

Locations

IT (1)