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

November 8, 2023 updated by: Saurav Raj Khatiwada, Nepal Mediciti Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Description:

The aim of this randomized comparative study is to investigate the effectiveness of two different approaches to postoperative analgesia in patients undergoing perianal surgery. The study will compare the use of Bupivacaine alone with Bupivacaine combined with Methylene Blue in a pudendal nerve block.

Perianal surgical procedures, such as abscess drainage, fistulectomy, and hemorrhoidectomy, can cause significant postoperative pain. The goal of this study is to find a more effective and prolonged method of pain relief to improve patient comfort and reduce the need for opioids.

Participants in this study will be individuals scheduled for elective perianal surgery and classified as ASA I and II. They will be randomly assigned to one of two groups:

  1. Group A: Participants will receive a pudendal nerve block with Bupivacaine and Methylene Blue.
  2. Group B: Participants will receive a pudendal nerve block with Bupivacaine alone.

The pudendal nerve block will be performed under ultrasound guidance at the ischial spine level. The needle will be accurately placed between the Sacro tuberous and sacrospinous ligaments for precise injection of the local anesthetic or the local anesthetic combined with Methylene Blue.

Throughout the study, the researchers will closely monitor the participants to assess the time to the first rescue analgesic and pain levels using the Numeric Rating Scale at specific time intervals (2, 6, 24, 48 hours, and 7 days). Additionally, any side effects, allergies, itching, hematoma, infection, or complications like loss of anal sphincter function will be recorded.

Patient satisfaction will also be evaluated using the Likert scale to determine the perceived effectiveness of the different approaches to postoperative analgesia.

By comparing the outcomes between the two groups, this study aims to determine whether the addition of Methylene Blue to Bupivacaine in a pudendal nerve block can prolong postoperative analgesia in patients undergoing perianal surgery. The findings from this study may contribute valuable insights into improving pain management strategies and enhancing the overall recovery experience for patients undergoing perianal surgical procedures.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Nepal
      • Lalitpur, Nepal, 44700
        • Recruiting
        • Nepal Mediciti Hospital
        • Contact:
        • Principal Investigator:
          • Saurav Raj Khatiwada, MD
        • Sub-Investigator:
          • Apurb Sharma, MD
        • Sub-Investigator:
          • Prajjwal Raj Bhattarai, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Bupivacaine
Other: Ultrasound guided Pudendal nerve block
Ultrasound guided bilateral pudendal nerve block
Experimental: Arm B
Bupivacaine with methylene blue
Other: Ultrasound guided Pudendal nerve block
Ultrasound guided bilateral pudendal nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to the first rescue analgesic administration (in minutes) in the two study groups
Time Frame: 48 hours
We will compare the time at which patients in either group will demand rescue analgesic
48 hours
Patient satisfaction assessed using the Likert scale after receiving Bupivacaine pudendal nerve block with or without Methylene Blue.
Time Frame: Seven days

We will ask the patient to select one of the following satisfaction scores:

Very satisfied Moderately satisfied Neither satisfied nor dissatisfied Moderately dissatisfied Very dissatisfied
Seven days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale (NRS) score for pain intensity at different time intervals
Time Frame: Seven days
Numeric Rating Scale (NRS) score for pain intensity will be measured at different time intervals (at 2, 6, 24, 48 hours, and 7 days) after surgery in both study groups.
Seven days
Complications
Time Frame: seven days
Incidence of complications related to the pudendal nerve block procedure, such as hematoma, infection, and allergic reactions will be captured when it is detected or at the end of seventh postoperative day
seven days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nepal Mediciti Hospital

Investigators

  • Principal Investigator: Pragati Koirala, MD, Nepal Mediciti

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

July 28, 2023

First Submitted That Met QC Criteria

August 6, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 8, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRC-RP-2079/80-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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