HemorrhoidsNCT05990569
Pudendal Nerve Block With Bupivacaine Alone and Bupivacaine With Methylene Blue for Postoperative Analgesia
A study testing Ultrasound guided Pudendal nerve block in people with Hemorrhoids and Anal Fissure and Fistula, run by Nepal Mediciti Hospital at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhoids, Anal Fissure and Fistula, Perianal Abscess
- What is being tested?
- Ultrasound guided Pudendal nerve block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNepal
- Study dates
- 12 Aug 2023to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All patients of ASA I and II undergoing elective perianal surgery under spinal anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Nepal1 site, 1 recruiting
- Recruiting
Nepal Mediciti Hospital
Lalitpur, 44700
Apurb Sharma, MD, +9779841221467, apurbsharma1976@gmail.com
Saurav Raj Khatiwada, MD
About this study
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 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.
Read more
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.
Read the 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.
- Conditions
- Hemorrhoids, Anal Fissure and Fistula, Perianal Abscess, Perianal Fistula, Pilonidal Sinus, Perianal Skin Tags
- Being tested
- Ultrasound guided Pudendal nerve block
- Medical subject headings
- Hemorrhoids, Fissure in Ano, Fistula, Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided Pudendal nerve blockOther
Ultrasound guided bilateral pudendal nerve block
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Bupivacaine Receives: Other: Ultrasound guided Pudendal nerve block |
| Arm B | Experimental | Bupivacaine with methylene blue Receives: Other: Ultrasound guided Pudendal nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Seven days
Secondary outcomes (2)
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.
Measured: Seven days
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
Measured: seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start12 Aug 2023
- Primary completionJun 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nepal Mediciti Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saurav Raj Khatiwada, Nepal Mediciti Hospital
- Investigators
- Pragati Koirala, MD, Principal investigator, Nepal Mediciti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990569
- Sponsor's protocol ID
- IRC-RP-2079/80-04
- Status last verified
- Nov 2023
- First submitted
- 28 Jul 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17701375Sim 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.
PubMed 24506265Naja 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.
PubMed 15625258Kunitake H, Poylin V. Complications Following Anorectal Surgery. Clin Colon Rectal Surg. 2016 Mar;29(1):14-21. doi: 10.1055/s-0035-1568145.
PubMed 26929747Ceulemans 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.
PubMed 30189793Garimella V, Cellini C. Postoperative pain control. Clin Colon Rectal Surg. 2013 Sep;26(3):191-6. doi: 10.1055/s-0033-1351138.
PubMed 24436674Abdi 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.
PubMed 16858468Ginimuge PR, Jyothi SD. Methylene blue: revisited. J Anaesthesiol Clin Pharmacol. 2010 Oct;26(4):517-20. No abstract available.
PubMed 21547182Lee 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.
PubMed 34079436Steen 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.
PubMed 34759239
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparative Study of Pudendal Nerve Block With Bupivacaine Alone and Bupivacaine With Methylene Blue for Postoperative Analgesia in Perianal Surgery
- ClinicalTrials.gov ID
- NCT05990569
- Acronym / sponsor ID
- IRC-RP-2079/80-04
- Conditions
- Hemorrhoids, Anal Fissure and Fistula, Perianal Abscess, Perianal Fistula, Pilonidal Sinus, Perianal Skin Tags
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nepal Mediciti HospitalUniversity, hospital or other
- Study start
- 12 Aug 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Other: Ultrasound guided Pudendal nerve blockBupivacaine |
| Arm B | Experimental | Other: Ultrasound guided Pudendal nerve blockBupivacaine with methylene blue |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients of ASA I and II undergoing elective perianal surgery under spinal anesthesia
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided Pudendal nerve blockUltrasound guided bilateral pudendal nerve block | Other | Arm A, Arm B |
Primary outcome
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
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
2 secondary outcomes
Numeric Rating Scale (NRS) score for pain intensity at different time intervals
Time frame: Seven days
Complications
Time frame: seven days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Background: PubMed 17701375Imbelloni 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.
- Background: PubMed 24506265Sim 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.
- Background: PubMed 15625258Naja 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.
- Background: PubMed 26929747Kunitake H, Poylin V. Complications Following Anorectal Surgery. Clin Colon Rectal Surg. 2016 Mar;29(1):14-21. doi: 10.1055/s-0035-1568145.
- Background: PubMed 30189793Ceulemans 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.
- Background: PubMed 24436674Garimella V, Cellini C. Postoperative pain control. Clin Colon Rectal Surg. 2013 Sep;26(3):191-6. doi: 10.1055/s-0033-1351138.
- Background: PubMed 16858468Abdi 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.
- Background: PubMed 21547182Ginimuge PR, Jyothi SD. Methylene blue: revisited. J Anaesthesiol Clin Pharmacol. 2010 Oct;26(4):517-20. No abstract available.
- Background: PubMed 34079436Lee 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.
- Background: PubMed 34759239Steen 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.
- Individual participant dataSharing planned: No
Related trials for Hemorrhoids
Not yet recruiting
Auricular Indwelling Needles Added to Diosmin/Hesperidin for Grade I-II Internal Hemorrhoids With Heat-Toxin Syndrome
Internal Haemorrhoids
Enrolling by invitation
Ultrasound-Guided Versus Landmark-Guided Pudendal Block for Post-Hemorrhoidectomy Pain
Hemorrhoids, Postoperative Pain
Not yet recruitingObservational study
Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment
Hemorrhoid, Hemorrhoid Bleeding
Recruiting
Ligasure Versus Conventional Diathermy in Hemorrhoidectomy
Hemorrhoids
Enrolling by invitationObservational study
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
Arteriovenous Malformation, Gastrointestinal Bleed
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pragati Koirala, MD principal investigator
Nepal Mediciti
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided Pudendal nerve block in people with Hemorrhoids and Anal Fissure and Fistula, run by Nepal Mediciti Hospital at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Apurb Sharma, MD (977-9841221467, apurbsharma1976@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to the first rescue analgesic administration (in minutes) in the two study groups (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05990569, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.