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Pudendal Nerve Block With Bupivacaine Alone and Bupivacaine With Methylene Blue for Postoperative Analgesia

NCT05990569 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-11-09

No results posted yet for this study

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.

Conditions

  • Hemorrhoids
  • Anal Fissure and Fistula
  • Perianal Abscess
  • Perianal Fistula
  • Pilonidal Sinus
  • Perianal Skin Tags

Interventions

OTHER

Ultrasound guided Pudendal nerve block

Ultrasound guided bilateral pudendal nerve block

Sponsors & Collaborators

  • Nepal Mediciti Hospital

    lead OTHER

Principal Investigators

  • Pragati Koirala, MD · Nepal Mediciti

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-12
Primary Completion
2024-06-30
Completion
2024-07-31

Countries

  • Nepal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05990569 on ClinicalTrials.gov