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

Primary Purpose

Hemorrhoids, Anal Fissure and Fistula, Perianal Abscess

Status
Not yet recruiting
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Ultrasound guided Pudendal nerve block
Sponsored by
Nepal Mediciti Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hemorrhoids

Eligibility Criteria

15 Years - 90 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: All patients of ASA I and II undergoing elective perianal surgery under spinal anesthesia Exclusion Criteria: 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

Sites / Locations

  • Nepal Mediciti Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm Description

Bupivacaine

Bupivacaine with methylene blue

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
July 28, 2023
Last Updated
August 6, 2023
Sponsor
Nepal Mediciti Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05990569
Brief Title
Pudendal Nerve Block With Bupivacaine Alone and Bupivacaine With Methylene Blue for Postoperative Analgesia
Official Title
A Randomized Comparative Study of Pudendal Nerve Block With Bupivacaine Alone and Bupivacaine With Methylene Blue for Postoperative Analgesia in Perianal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nepal Mediciti Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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: Group A (Case Group): Participants will receive a pudendal nerve block with Bupivacaine combined with Methylene Blue. 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.
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: Group A: Participants will receive a pudendal nerve block with Bupivacaine and Methylene Blue. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids, Anal Fissure and Fistula, Perianal Abscess, Perianal Fistula, Pilonidal Sinus, Perianal Skin Tags

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Bupivacaine
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Bupivacaine with methylene blue
Intervention Type
Other
Intervention Name(s)
Ultrasound guided Pudendal nerve block
Intervention Description
Ultrasound guided bilateral pudendal nerve block
Primary Outcome Measure Information:
Title
Time to the first rescue analgesic administration (in minutes) in the two study groups
Description
We will compare the time at which patients in either group will demand rescue analgesic
Time Frame
48 hours
Title
Patient satisfaction assessed using the Likert scale after receiving Bupivacaine pudendal nerve block with or without Methylene Blue.
Description
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
Time Frame
Seven days
Secondary Outcome Measure Information:
Title
Numeric Rating Scale (NRS) score for pain intensity at different time intervals
Description
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.
Time Frame
Seven days
Title
Complications
Description
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
Time Frame
seven days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All patients of ASA I and II undergoing elective perianal surgery under spinal anesthesia Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Apurb Sharma, MD
Phone
977-9841221467
Email
apurbsharma1976@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Prajjwal Bhattarai, MD
Phone
977-9851165664
Email
prajjwal.bhattarai@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pragati Koirala, MD
Organizational Affiliation
Nepal Mediciti
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nepal Mediciti Hospital
City
Lalitpur
ZIP/Postal Code
44700
Country
Nepal
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Apurb Sharma, MD
Phone
+9779841221467
Email
apurbsharma1976@gmail.com
First Name & Middle Initial & Last Name & Degree
Saurav Raj Khatiwada, MD
First Name & Middle Initial & Last Name & Degree
Apurb Sharma, MD
First Name & Middle Initial & Last Name & Degree
Prajjwal Raj Bhattarai, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17701375
Citation
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.
Results Reference
background
PubMed Identifier
24506265
Citation
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.
Results Reference
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PubMed Identifier
15625258
Citation
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.
Results Reference
background
PubMed Identifier
26929747
Citation
Kunitake H, Poylin V. Complications Following Anorectal Surgery. Clin Colon Rectal Surg. 2016 Mar;29(1):14-21. doi: 10.1055/s-0035-1568145.
Results Reference
background
PubMed Identifier
30189793
Citation
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.
Results Reference
background
PubMed Identifier
24436674
Citation
Garimella V, Cellini C. Postoperative pain control. Clin Colon Rectal Surg. 2013 Sep;26(3):191-6. doi: 10.1055/s-0033-1351138.
Results Reference
background
PubMed Identifier
16858468
Citation
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.
Results Reference
background
PubMed Identifier
21547182
Citation
Ginimuge PR, Jyothi SD. Methylene blue: revisited. J Anaesthesiol Clin Pharmacol. 2010 Oct;26(4):517-20. No abstract available.
Results Reference
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PubMed Identifier
34079436
Citation
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.
Results Reference
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PubMed Identifier
34759239
Citation
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.
Results Reference
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Pudendal Nerve Block With Bupivacaine Alone and Bupivacaine With Methylene Blue for Postoperative Analgesia

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