A Randomized Comparative Study of Pudendal Nerve Block With Bupivacaine Alone and Bupivacaine With Methylene Blue for Postoperative Analgesia in Perianal Surgery

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Study Description: The goal of this clinical trial is to compare the duration of postoperative pain relief achieved with two different approaches to pudendal nerve block in patients undergoing elective perianal surgery. The main question this study aims to answer is whether adding Methylene Blue to Bupivacaine pudendal nerve block can prolong postoperative analgesia compared to using Bupivacaine alone. Participants in this study will be individuals with ASA I and II physical status undergoing elective perianal surgery under spinal anesthesia. They will be randomly assigned to one of two groups: 1. Group A (Case Group): Participants will receive a pudendal nerve block with Bupivacaine combined with Methylene Blue. 2. Group B (Control Group): Participants will receive a pudendal nerve block with Bupivacaine alone. The pudendal nerve block will be performed using ultrasound guidance at the level of the ischial spine. The needle tip will be positioned between the Sacro tuberous and sacrospinous ligaments to inject the local anesthetic or the local anesthetic combined with Methylene Blue. Throughout the study, the researchers will monitor the time to the first rescue analgesic, assess pain levels using the Numeric Rating Scale at various time intervals (2, 6, 24, 48 hours, and 7 days), and observe for any side effects or complications related to the intervention. Participants will be closely observed after surgery to assess their pain levels and analgesic requirements. The researchers will also evaluate patient satisfaction using the Likert scale. By comparing the outcomes between the two groups, the study aims to determine if the addition of Methylene Blue to Bupivacaine pudendal nerve block provides superior postoperative analgesia in perianal surgery patients. This information will contribute to the understanding of effective pain management strategies for individuals undergoing perianal surgical procedures and potentially reduce the need for opioids and improve patient outcomes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 90
Healthy Volunteers: t
View:

• All patients of ASA I and II undergoing elective perianal surgery under spinal anesthesia

Locations
Other Locations
Nepal
Nepal Mediciti Hospital
RECRUITING
Lalitpur
Contact Information
Primary
Apurb Sharma, MD
apurbsharma1976@gmail.com
977-9841221467
Backup
Prajjwal Bhattarai, MD
prajjwal.bhattarai@gmail.com
977-9851165664
Time Frame
Start Date: 2023-08-12
Estimated Completion Date: 2024-07
Participants
Target number of participants: 60
Treatments
Experimental: Arm A
Bupivacaine
Experimental: Arm B
Bupivacaine with methylene blue
Related Therapeutic Areas
Sponsors
Leads: Nepal Mediciti Hospital

This content was sourced from clinicaltrials.gov