Pain control without opioids after keyhole surgery to remove fallopian tubes

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a fallopian tube who are having keyhole (laparoscopic or robotic) tube removal or another tube-tying procedure for a non-cancer reason. It compares pain control with and without opioid pain medicine after surgery.

Age

18 years and older

Sex

Female

Disease stage

Keyhole (laparoscopic or robotic) removal of one or both fallopian tubes, or another tube-tying procedure, as the main operation. The reason for surgery must be benign (not cancer).

Earlier treatment

People who have used opioids long-term (more than three months) cannot join.

Main reasons for not taking part

• Long-lasting pain conditions, such as fibromyalgia
• Allergy to or other reason not to take the study medicines, such as acetaminophen or oxycodone
• Tube removal done together with a major gynaecological surgery, such as hysterectomy, or switched to open surgery
• Tube removal done to treat an ectopic pregnancy (pregnancy outside the womb)
• History of stomach lining inflammation (gastritis) or bleeding in the gut

The registry criteria, word for word

What the trial wants to find out

The purpose of this study is to evaluate patient-reported post-operative pain scores following minimally invasive tubal sterilization procedures to determine if a multimodal, non-opioid pain control regimen is non-inferior to a pain control regimen including opioids.

The 2 groups in the trial

• Arm 1 - Opioid Post-Op Pain RegimenExisting treatment, for comparison

  Patients randomized to Arm 1 will receive the current most commonly prescribed pain control regimen after a minimally invasive tubal sterilization procedure at discharge. These medications include: Tylenol 500 mg orally every 6 hours scheduled x 30 tablets Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets and Oxycodone 5 mg orally every 4 hours as needed x 12 tablets All patients will be instructed to use Acetaminophen and Ibuprofen around the clock for the first 72 hours and as needed thereafter

  Treatment: Acetaminophen, Ibuprofen, and Oxycodone

• Arm 2 - Non-Opioid Post-Op Pain RegimenTreatment being tested

  Patients randomized to Arm 2 will not receive an opioid prescription after minimally invasive tubal sterilization procedures at discharge. They will receive only Tylenol and Ibuprofen as follows: Tylenol 500 mg orally every 6 hours scheduled x 30 tablets Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets and All patients will be instructed to use Acetaminophen and Ibuprofen around the clock for the first 72 hours and as needed thereafter. Participants will be informed that if they need additional pain medications, these will not be withheld. Participants in the second arm who require additional pain medications will receive the same amount of oxycodone as in arm 1.

  Treatment: Acetaminophen and Ibuprofen