Pudendal Nerve Block With Bupivacaine Alone and Bupivacaine With Methylene Blue for Postoperative Analgesia
NCT ID: NCT05990569
Last Updated: 2023-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2023-08-12
2024-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Transvaginal Versus Fluoroscopy-guided Trans Gluteal Pudendal Nerve Block for Pudendal Neuralgia
NCT06644261
Comparative Analysis of Hypobaric Versus Hyperbaric Bupivacaine for Spinal Anesthesia in Day-Case Anorectal Surgery
NCT05409820
The Effect of Pre-sacral Nerve Block on Immediate Post-operative Pain Following Laparoscopic Hysterectomy.
NCT03646006
Efficacy of Methylene Blue Plus Ropivacaine for Post-Hemorrhoidectomy Pain.
NCT07164807
Adding Ketamine to Low Dose Bupivacaine in Saddle Block for Perianal Surgery
NCT03264430
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A
Bupivacaine
Ultrasound guided Pudendal nerve block
Ultrasound guided bilateral pudendal nerve block
Arm B
Bupivacaine with methylene blue
Ultrasound guided Pudendal nerve block
Ultrasound guided bilateral pudendal nerve block
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ultrasound guided Pudendal nerve block
Ultrasound guided bilateral pudendal nerve block
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
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
15 Years
90 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nepal Mediciti Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Saurav Raj Khatiwada
Resident Doctor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pragati Koirala, MD
Role: PRINCIPAL_INVESTIGATOR
Nepal Mediciti
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nepal Mediciti Hospital
Lalitpur, , Nepal
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Kunitake H, Poylin V. Complications Following Anorectal Surgery. Clin Colon Rectal Surg. 2016 Mar;29(1):14-21. doi: 10.1055/s-0035-1568145.
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.
Garimella V, Cellini C. Postoperative pain control. Clin Colon Rectal Surg. 2013 Sep;26(3):191-6. doi: 10.1055/s-0033-1351138.
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.
Ginimuge PR, Jyothi SD. Methylene blue: revisited. J Anaesthesiol Clin Pharmacol. 2010 Oct;26(4):517-20. No abstract available.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRC-RP-2079/80-04
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.