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HemorrhoidsNCT07889869

Ultrasound-Guided Versus Landmark-Guided Pudendal Block for Post-Hemorrhoidectomy Pain

A study testing Ultrasound-Guided Pudendal Nerve Block and Landmark-Guided Pudendal Nerve Block in people with Hemorrhoids and Postoperative Pain, run by Konya City Hospital at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Hemorrhoid surgery is often followed by significant pain during the first few days after the operation. Pudendal nerve block is a pain-control technique that can help reduce discomfort after surgery. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Ultrasound-Guided Pudendal Nerve Block and Landmark-Guided Pudendal Nerve Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
14 May 2026to Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 65 years.
  • American Society of Anesthesiologists (ASA) physical status I or II.
  • Diagnosis of Grade III hemorrhoidal disease.
  • Scheduled to undergo Milligan-Morgan hemorrhoidectomy.
  • Ability to understand the study procedures and provide written informed consent.

Who cannot join

  • Previous anorectal surgery.
  • Chronic pelvic pain.
  • Vertebral or pelvic deformity that may interfere with the procedure.
  • Known coagulation disorders or anticoagulation contraindicating regional anesthesia.
  • Known allergy or hypersensitivity to lidocaine or bupivacaine.
  • Pregnancy or breastfeeding.
Show all 9Show fewer
  • Refusal or inability to provide written informed consent.
  • Failed or technically unsuccessful pudendal nerve block.
  • Inability to complete postoperative outcome assessments.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Konya City Hospital

    Konya, Konya, 42020

Other trials in Turkey (Türkiye)

About this study

Official title: Ultrasound-Guided Versus Landmark-Guided Pudendal Nerve Block for Postoperative Pain Control After Milligan-Morgan Hemorrhoidectomy: A Prospective Randomized Double-Blind Trial

Hemorrhoid surgery is often followed by significant pain during the first few days after the operation. Pudendal nerve block is a pain-control technique that can help reduce discomfort after surgery. This study will compare two different methods of performing a pudendal nerve block: an ultrasound-guided method and a conventional landmark-guided method.

Patients undergoing Milligan-Morgan hemorrhoidectomy will be randomly assigned to one of the two techniques. The study will evaluate postoperative pain levels, pain medication use, treatment-related complications, and patient satisfaction.

The study hypothesis is that the ultrasound-guided technique may provide better pain relief and reduce the need for additional pain medication compared with the landmark-guided technique.

Read the detailed description

Hemorrhoidal disease is one of the most common benign anorectal disorders worldwide. Milligan-Morgan hemorrhoidectomy remains one of the most effective surgical treatments for advanced hemorrhoidal disease; however, postoperative pain continues to be a major limitation of the procedure. Pain after hemorrhoidectomy may delay mobilization, increase analgesic requirements, prolong recovery, and negatively affect patient satisfaction.

Several pharmacological and regional analgesic techniques have been investigated to improve postoperative pain management following hemorrhoidectomy. Among these techniques, pudendal nerve block has gained increasing attention because it provides targeted analgesia to the anal canal and perianal region while minimizing systemic adverse effects associated with opioid-based pain management. Previous randomized controlled trials and meta-analyses have demonstrated that pudendal nerve block can reduce postoperative pain intensity, decrease analgesic consumption, and improve postoperative recovery after anorectal surgery.

Traditionally, pudendal nerve block has been performed using anatomical landmarks identified by digital palpation of the ischial spine. Although this technique is widely used and does not require additional equipment, the success of the block depends largely on operator experience and anatomical variation. Inaccurate needle placement may reduce block efficacy and increase the risk of technical failure.

The introduction of ultrasound-guided regional anesthesia has enabled direct visualization of anatomical structures, including the internal pudendal vessels and surrounding soft tissues. Ultrasound guidance may improve needle placement accuracy, facilitate local anesthetic spread around the target nerve, and potentially reduce procedure-related complications. Several studies have reported favorable outcomes with ultrasound-guided pudendal nerve block; however, most available evidence compares pudendal nerve block with other anesthetic or analgesic techniques rather than directly comparing different pudendal block approaches.

Currently, there is limited prospective randomized evidence comparing ultrasound-guided and conventional landmark-guided pudendal nerve block techniques in patients undergoing hemorrhoidectomy. Therefore, the relative clinical advantages of ultrasound guidance in this setting remain uncertain.

This single-center, prospective, randomized, double-blind clinical trial has been designed to compare ultrasound-guided and landmark-guided bilateral pudendal nerve block techniques performed after Milligan-Morgan hemorrhoidectomy. The study seeks to determine whether ultrasound guidance provides clinically meaningful benefits in postoperative pain management and recovery when compared with the conventional landmark-guided approach. The results may contribute to the optimization of perioperative pain management strategies and help guide evidence-based selection of pudendal nerve block techniques in routine colorectal surgical practice.

Being tested
Ultrasound-Guided Pudendal Nerve Block, Landmark-Guided Pudendal Nerve Block
Keywords
Hemorrhoids, Hemorrhoidectomy, Pudendal Nerve Block, Postoperative Pain, Ultrasound-Guided Pudendal Nerve Block, Landmark-Guided Pudendal Nerve Block, Regional Anesthesia, Pain Management
Medical subject headings
Hemorrhoids, Pain, Postoperative, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound-Guided Pudendal Nerve BlockProcedure or surgery

    Bilateral pudendal nerve block performed under ultrasound guidance using a standardized mixture of 1% lidocaine and 0.25% bupivacaine following Milligan-Morgan hemorrhoidectomy.

  • Landmark-Guided Pudendal Nerve BlockProcedure or surgery

    Bilateral pudendal nerve block performed using anatomical landmarks identified by digital palpation of the ischial spine with the same standardized mixture of 1% lidocaine and 0.25% bupivacaine following Milligan-Morgan hemorrhoidectomy.

Study groups in NCT07889869
Study groupRoleWhat they receive
Ultrasound-Guided Pudendal Nerve BlockExperimentalParticipants undergoing Milligan-Morgan hemorrhoidectomy will receive bilateral ultrasound-guided pudendal nerve block after completion of surgery under spinal anesthesia. The block will be performed by an anesthesiologist using ultrasound guidance and a standardized local anesthetic mixture.
Receives: Procedure: Ultrasound-Guided Pudendal Nerve Block
Landmark-Guided Pudendal Nerve BlockActive comparatorParticipants undergoing Milligan-Morgan hemorrhoidectomy will receive bilateral landmark-guided pudendal nerve block after completion of surgery under spinal anesthesia. The block will be performed using digital palpation of the ischial spine and the same standardized local anesthetic mixture.
Receives: Procedure: Landmark-Guided Pudendal Nerve Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Pain Intensity at 24 Hours

    Postoperative pain intensity will be assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).

    Measured: 24 hours after surgery

Secondary outcomes (5)
  1. Postoperative Pain Intensity at 6, 12, and 48 Hours

    Postoperative pain intensity will be assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).

    Measured: 6, 12, and 48 hours after surgery

  2. Total Postoperative Analgesic Consumption

    Total rescue analgesic consumption during the first 48 hours after surgery will be recorded and compared between study groups.

    Measured: Within 48 hours after surgery

  3. Incidence of Early Postoperative Complications

    The incidence of urinary retention and postoperative nausea and vomiting occurring during the first 48 hours after surgery will be recorded.

    Measured: Within 48 hours after surgery

  4. Patient Satisfaction

    Patient satisfaction with postoperative pain management will be assessed at 48 hours after surgery using a 5-point Likert scale, with higher scores indicating greater satisfaction.

    Measured: 48 hours after surgery

  5. Quality of Postoperative Recovery

    Quality of postoperative recovery will be assessed at 48 hours after surgery using the Quality of Recovery-15 (QoR-15) questionnaire. The questionnaire consists of 15 items, with a total score ranging from 0 to 150. Higher scores indicate better postoperative recovery.

    Measured: 48 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2026
  2. Study start14 May 2026
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned in a 1:1 ratio to receive either ultrasound-guided bilateral pudendal nerve block or landmark-guided bilateral pudendal nerve block following Milligan-Morgan hemorrhoidectomy. Both interventions will be performed after surgery under spinal anesthesia, and participants will remain in their assigned intervention group throughout the study.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07889869
Sponsor's protocol ID
AEŞH-EK-2026-076
Status last verified
Oct 2026
First submitted
25 Jun 2026
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
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 17701375
  • Pan P, Jiang J, Zhang X, Yang W, Ding W. Ultrasound-guided pudendal nerve block for postoperative pain management in procedures for prolapse and hemorrhoids: a randomized, double-blinded trial. Int J Colorectal Dis. 2025 Jul 17;40(1):159. doi: 10.1007/s00384-025-04953-3.

    PubMed 40676415
  • Di Giuseppe M, Saporito A, La Regina D, Tasciotti E, Ghielmini E, Vannelli A, Pini R, Mongelli F. Ultrasound-guided pudendal nerve block in patients undergoing open hemorrhoidectomy: a double-blind randomized controlled trial. Int J Colorectal Dis. 2020 Sep;35(9):1741-1747. doi: 10.1007/s00384-020-03630-x. Epub 2020 May 30.

    PubMed 32474710
  • Xia S, Luo L, Wu W, Lu K, Jiang T, Li Y. The role of pudendal nerve block in hemorrhoid surgery: a systematic review and meta-analysis of double-blind randomized controlled trials. Front Med (Lausanne). 2023 Dec 13;10:1283512. doi: 10.3389/fmed.2023.1283512. eCollection 2023.

    PubMed 38152300
  • Mongelli F, Treglia G, La Regina D, Di Giuseppe M, Galafassi J, Majno-Hurst PE, Christoforidis D. Pudendal Nerve Block in Hemorrhoid Surgery: A Systematic Review and Meta-analysis. Dis Colon Rectum. 2021 May;64(5):617-631. doi: 10.1097/DCR.0000000000001985.

    PubMed 33591044

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound-Guided Pudendal Nerve Block and Landmark-Guided Pudendal Nerve Block in people with Hemorrhoids and Postoperative Pain, run by Konya City Hospital at 1 site in Turkey (Türkiye).

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 5 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 22 Oct 2026. 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 Turkey (Türkiye). 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Pain Intensity at 24 Hours (time frame: 24 hours after surgery). 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 NCT07889869, which also lists 5 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 22 Oct 2026.

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