Clinical trial · Interventional
Pudendal Nerve Block With Bupivacaine Alone and Bupivacaine With Methylene Blue for Postoperative Analgesia
A Randomized Comparative Study of Pudendal Nerve Block With Bupivacaine Alone and Bupivacaine With Methylene Blue for Postoperative Analgesia in Perianal Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Fissure and Fistula | — | UNRESOLVED | — |
| Hemorrhoids | — | UNRESOLVED | — |
| Perianal Abscess | — | UNRESOLVED | — |
| Perianal Fistula | — | UNRESOLVED | — |
| Perianal Skin Tags | — | UNRESOLVED | — |
| Pilonidal Sinus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultrasound guided Pudendal nerve block | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Bupivacaine
- interventionNames
- Other: Ultrasound guided Pudendal nerve block
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Bupivacaine with methylene blue
- interventionNames
- Other: Ultrasound guided Pudendal nerve block
Primary outcomes (2)
- measure
- Time to the first rescue analgesic administration (in minutes) in the two study groups
- timeFrame
- 48 hours
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDImbelloni 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
- BACKGROUNDSim 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
- BACKGROUNDNaja 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
- BACKGROUNDKunitake 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
- BACKGROUNDCeulemans 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
- BACKGROUNDGarimella V, Cellini C. Postoperative pain control. Clin Colon Rectal Surg. 2013 Sep;26(3):191-6. doi: 10.1055/s-0033-1351138. PMID 24436674
- BACKGROUNDAbdi 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
- BACKGROUNDGinimuge PR, Jyothi SD. Methylene blue: revisited. J Anaesthesiol Clin Pharmacol. 2010 Oct;26(4):517-20. No abstract available.