An interventional study of abdominal Jackson-Pratt drain in Postoperative Pain, sponsored by Università degli Studi dell'Insubria. Not yet recruiting at 1 site in Italy. Open to female participants. Per ClinicalTrials.gov, last updated 2022-11-02.
Sponsored by Università degli Studi dell'Insubria · Not applicable, Interventional, and Supportive care
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Among 115 studies in Pain, Postoperative with a site in Italy — 18 open to participants now, 21 under way, none of them phase 3. Pain, Postoperative · Italy.
Among the 115 studies in Pain, Postoperative with a site in Italy, this one is the 35th largest by planned enrollment of the 86 interventional ones that give a count, is one of 7 that started in 2025, is one of 63 with no phase, reaches primary completion later than 11 of the 20 other live ones, and was the 40th registered.
5,644 studies on the registry are indexed under Pain, Postoperative; 1,229 are open to participants now.
Browse Pain, Postoperative studies →18 of the 115 studies in Pain, Postoperative with a site in Italy are open now. Recruiting first, the newest first:
University of Rome Tor Vergata · Sites in Italy
Ages 18–75 · Women only
ASST Sette Laghi · Sites in Italy
Ages 18+
ASST Gaetano Pini-CTO · Sites in Italy
Ages 18+
A.O.U. Città della Salute e della Scienza · Sites in Italy
Ages 18–85
AUSL Romagna Rimini · Sites in Italy
Ages 18–45 · Women only
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 678 Pain, Postoperative studies recruiting now, 241 (36%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: female · no healthy volunteers.
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115 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 5 · Phase 3 7 · Phase 4 11
First in 2006; this study’s year is marked. 7 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 94 is above the median of 75 across 4,825 interventional studies indexed under Pain, Postoperative.
Median enrollment 79 across the 86 interventional studies, 120 across the 29 observational. Of the 71 that completed or were terminated, 6 (8%) have results posted.
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6 of 115 have an industry lead sponsor. The 10 most frequent:
Università degli Studi dell'Insubria is the lead sponsor of 68 studies on the registry; 8 are open to participants now.
Università degli Studi dell'Insubria has 3 studies filed under Pain, Postoperative — fewer than ten, so there is no comparison to draw.
6 of the studies in Pain, Postoperative with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06182059Policlinico di Monza SpAPersistent Post Surgical Pain After Total Knee Arthroplasty | 2027-01-31 |
| NCT07831096ASST Sette LaghiAnterior Suprascapular Versus Interscalene Block for Postoperative Analgesia After Arthroscopic Shoulder Surgery in the Outpatient Setting | 2027-02 |
| NCT06244732IRCCS Policlinico S. DonatoPain Control After Aortic EndoaneurYsmEctomy (POPEYE) | 2027-02 |
| NCT07239817ASST Gaetano Pini-CTOPENG Block + LIA For Endoprosthesis Surgery | 2027-02-28 |
| NCT07250373Fondazione Policlinico Universitario Agostino Gemelli IRCCSSerratus Posterior Superior Intercostal Plane (SPSIP) Block Versus Intercostal Nerve (ICN) Block in Patients Undergoing Uniportal-VATS. | 2027-04-30 |
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Among the 115 studies in Pain, Postoperative with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Patients in this arm will not undergo one-hour application of abdominal Jackson-Pratt drain at the end of laparoscopic procedure.
One-hour application of abdominal Jackson-Pratt drain at the end of laparoscopic procedure.
Pain
Pain perception, expressed as Visual Analogue Score (0-10).
Time frame: 6 hours after surgery.
Pain
Pain perception, expressed as Visual Analogue Score (0-10).
Time frame: 12 hours after surgery.
Pain
Pain perception, expressed as Visual Analogue Score (0-10).
Time frame: 24 hours after surgery.
Use of Analgesic
Number of requests for rescue analgesia (30 mg ketorolac tromethamine, administrated intravenously).
Time frame: During the 48 hours after surgery.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jun 2025; primary completion for Jun 2026, 12 months later.
Of 2,094 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 12 months is close to that.
Counting every sponsor, half of 2,107 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Università degli Studi dell'Insubria