Comparing two methods of pain relief after perianal surgery
A Randomized Comparative Study of Pudendal Nerve Block With Bupivacaine Alone and Bupivacaine With Methylene Blue for Postoperative Analgesia in Perianal Surgery
This study is testing two different ways to relieve pain after perianal surgery to see which one works better for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 15 Years to 90 Years |
| Sex | All |
| Sponsor | Nepal Mediciti Hospital Academic / other |
| Locations | 1 site (Lalitpur) |
| Trial ID | NCT05990569 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of two different pudendal nerve block techniques for postoperative pain relief in patients undergoing elective perianal surgery. Participants will be randomly assigned to receive either Bupivacaine alone or Bupivacaine combined with Methylene Blue. The pudendal nerve block will be performed using ultrasound guidance to ensure accurate placement of the anesthetic. Pain levels and the time to first rescue analgesic will be monitored at various intervals post-surgery to determine which method provides longer-lasting relief.
Who should consider this trial
Good fit: Ideal candidates for this study are patients classified as ASA I and II who are scheduled for elective perianal surgery under spinal anesthesia.
Not a fit: Patients with allergies to local anesthetics or Methylene Blue, or those with certain medical conditions such as coagulopathy or neurological deficits, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative pain management for patients undergoing perianal surgery, potentially reducing opioid use.
How similar studies have performed: While the specific combination of Bupivacaine and Methylene Blue in pudendal nerve blocks is less commonly studied, similar approaches have shown promise in enhancing analgesia in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients of ASA I and II undergoing elective perianal surgery under spinal anesthesia Exclusion Criteria: 1. Patient's refusal 2. Patient with a history of allergy to the local anesthetic or Methylene blue 3. Bleeding diathesis or coagulopathy 4. Extensive infection at the site of injection 5. Pregnancy and lactating mother 6. Spinal abnormality 7. Patients with neurological deficit
Where this trial is running
Lalitpur
- Nepal Mediciti Hospital — Lalitpur, Nepal (Recruiting)
Study contacts
- Principal investigator: Pragati Koirala, MD — Nepal Mediciti
- Study coordinator: Apurb Sharma, MD
- Email: apurbsharma1976@gmail.com
- Phone: 977-9841221467
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.