Effects of Rectal Indomethacin Suppository on Postoperative CRBD in Patients Undergoing LRP

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-80
SponsorZhejiang University

About this trial

The postoperative incidence of catheter-related bladder discomfort (CRBD) ranges from 47% to 95%. It increases postoperative pain and agitation, thus requiring early intervention. Although a variety of drugs are used for the prevention or treatment of CRBD, the adverse reactions of most of these drugs have limited their clinical application. In long-term clinical practice, we found that indomethacin suppository has a good therapeutic effect on the discomfort of pelvic-related organs caused by nociceptive stimulation. However, its preventive effect on CRBD has not been reported yet. We hypothesized that indomethacin suppository has a preventive effect on postoperative CRBD. To verify this hypothesis, patients undergoing laparoscopic radical prostatectomy were enrolled in the study. Patients in the intervention group received 50 mg of indomethacin suppository via the rectal route immediately after surgery, while those in the control group received no treatment. The severity of CRBD, pain scores, consumption of analgesics, other perioperative adverse reactions, and patient satisfaction were observed and recorded at 0, 1, 2, and 6 hours after surgery.

Eligibility criteria

Qualifiers

Aged 18 to 80 years old (inclusive);

American Society of Anesthesiologists (ASA) physical status classification Class I-III;

Undergoing elective laparoscopic radical prostatectomy under general anesthesia;

Having a clear understanding of the study, voluntarily participating, and providing informed consent signed by themselves or their family members.

Disqualifiers

Pre-existing bladder diseases, such as overactive bladder (frequency of micturition > 3 times per night or > 8 times within 24 hours), neurogenic bladder, and bladder outlet obstruction;

Postoperative status of pelvic organs or spine that affects bladder function;

Postoperative status of total proctocolectomy;

Severe cardiac insufficiency (activity tolerance < 4 METs) or clearly diagnosed coronary heart disease;

Trial design

Treatments tested in this trial

  • Indomethacin suppository

Treatment groups

130 Participants
are divided into 2 treatment groups

Sponsors and collaborators