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

NCT05990569 | Unknown DMC

• 1 other identifier: IRC-RP-2079/80-04
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 1.Group A (Case Group): Participants will receive a pudendal nerve block with Bupivacaine combined with Methylene Blue.
2. 2.Group B (Control Group): Participants will receive a pudendal nerve block with Bupivacaine alone.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Time to the first rescue analgesic administration (in minutes) in the two study groups

  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.

  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 Outcomes (2)

• Numeric Rating Scale (NRS) score for pain intensity at different time intervals

  Seven days

• Complications

  seven days

Study Arms (2)

Arm A

EXPERIMENTAL

Bupivacaine

Other: Ultrasound guided Pudendal nerve block

Arm B

EXPERIMENTAL

Bupivacaine with methylene blue

Other: Ultrasound guided Pudendal nerve block

Interventions

Ultrasound guided Pudendal nerve block OTHER

Ultrasound guided bilateral pudendal nerve block

Arm A; Arm B

Eligibility Criteria

• Age: 15 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patient's refusal
• Patient with a history of allergy to the local anesthetic or Methylene blue
• Bleeding diathesis or coagulopathy
• Extensive infection at the site of injection
• Pregnancy and lactating mother
• Spinal abnormality
• Patients with neurological deficit

Sponsors & Collaborators

• Nepal Mediciti Hospital: lead

Study Sites (1)

Nepal Mediciti Hospital

Lalitpur, 44700, Nepal

RECRUITING

Related Publications (10)

• Imbelloni LE, Vieira EM, Gouveia MA, Netinho JG, Spirandelli LD, Cordeiro JA. Pudendal block with bupivacaine for postoperative pain relief. Dis Colon Rectum. 2007 Oct;50(10):1656-61. doi: 10.1007/s10350-007-0216-7.

  PMID: 17701375 BACKGROUND

• Sim HL, Tan KY. Randomized single-blind clinical trial of intradermal methylene blue on pain reduction after open diathermy haemorrhoidectomy. Colorectal Dis. 2014 Aug;16(8):O283-7. doi: 10.1111/codi.12587.

  PMID: 24506265 BACKGROUND

• Naja Z, Ziade MF, Lonnqvist PA. Nerve stimulator guided pudendal nerve block decreases posthemorrhoidectomy pain. Can J Anaesth. 2005 Jan;52(1):62-8. doi: 10.1007/BF03018582.

  PMID: 15625258 BACKGROUND

• Kunitake H, Poylin V. Complications Following Anorectal Surgery. Clin Colon Rectal Surg. 2016 Mar;29(1):14-21. doi: 10.1055/s-0035-1568145.

  PMID: 26929747 BACKGROUND

• Ceulemans A, De Looze D, Van de Putte D, Stiers E, Coppens M. High post-operative pain scores despite multimodal analgesia in ambulatory anorectal surgery: a prospective cohort study. Acta Chir Belg. 2019 Aug;119(4):224-230. doi: 10.1080/00015458.2018.1500802. Epub 2018 Sep 7.

  PMID: 30189793 BACKGROUND

• Garimella V, Cellini C. Postoperative pain control. Clin Colon Rectal Surg. 2013 Sep;26(3):191-6. doi: 10.1055/s-0033-1351138.

  PMID: 24436674 BACKGROUND

• Abdi S, Shenouda P, Patel N, Saini B, Bharat Y, Calvillo O. A novel technique for pudendal nerve block. Pain Physician. 2004 Jul;7(3):319-22.

  PMID: 16858468 BACKGROUND

• Ginimuge PR, Jyothi SD. Methylene blue: revisited. J Anaesthesiol Clin Pharmacol. 2010 Oct;26(4):517-20. No abstract available.

  PMID: 21547182 BACKGROUND

• Lee SW, Han HC. Methylene Blue Application to Lessen Pain: Its Analgesic Effect and Mechanism. Front Neurosci. 2021 May 17;15:663650. doi: 10.3389/fnins.2021.663650. eCollection 2021.

  PMID: 34079436 BACKGROUND

• Steen CJ, Lam D, Chandra R, Chua JYJ, An V, Keck JO. Pudendal Nerve Block for Posthemorrhoidectomy Pain: A Prospective, Single-Blinded Randomized Control Trial. Dis Colon Rectum. 2022 Apr 1;65(4):546-551. doi: 10.1097/DCR.0000000000002293.

  PMID: 34759239 BACKGROUND

MeSH Terms

Conditions

Hemorrhoids; Fissure in Ano; Fistula; Pilonidal Sinus

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Anus Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Cysts; Neoplasms

Study Officials

• Pragati Koirala, MD

  Nepal Mediciti

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Apurb Sharma, MD

CONTACT

977-9841221467; apurbsharma1976@gmail.com

Prajjwal Bhattarai, MD

CONTACT

977-9851165664; prajjwal.bhattarai@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 14, 2023
• Study Start: August 12, 2023
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)