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NCT Number: NCT07015775

Evaluation of the Analgesic Efficacy of an Ultrasound-guided Transperineal Pudendal Block in Outpatient Hemorrhoidal Surgery

In a population of patients undergoing hemorrhoidal surgery under general anesthesia and divided into two equal groups based on the method used for intraoperative pudendal nerve block and its branches in the ischioanal fossa:

Group 1: Pudendal block guided by neurostimulation Group 2: Pudendal block guided by ultrasound

The primary objective of this study is to compare the maximum immediate postoperative pain score between the two groups (pain reported by the patients in the recovery room on a simple numeric scale before morphine titration).

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Key information

Conditions

Hemorrhoids Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This is a multicenter, prospective, randomized, double-blind study conducted on two parallel groups of patients undergoing hemorrhoidal surgery (pudendal block guided by neurostimulation versus pudendal block guided by ultrasound).

Study Duration The total study duration per patient is 7 days. The recruitment period is set at 12 months.

Justification of the Experimental Protocol The aim of this study is to compare two methods of performing a pudendal block. Patient allocation to either strategy will be determined by randomization. Bilateral pudendal nerve block and its branches in the ischioanal fossa will be performed after induction of general anesthesia.

To maintain double blinding, postoperative data will be collected by a physician other than the anesthesiologist performing the block, and by nursing staff under their supervision. None of these personnel will be informed of the patient's group allocation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult male or female patient
  • Patient who has signed informed consent to participate in the study
  • Patient scheduled for outpatient hemorrhoidal surgery under general anesthesia

Exclusion criteria

  • History of hemorrhoidal surgery
  • Allergy or contraindication to any of the medications used in the study
  • Patient undergoing surgery under spinal anesthesia
  • History of chronic pain requiring opioid use, unrelated to hemorrhoids
  • Mental impairment or any other condition that could hinder understanding or strict adherence to the protocol
  • Patient not affiliated with the French national health insurance system
  • Patient under legal protection (e.g., guardianship, trusteeship, or court protection)
  • Pregnant woman or woman at risk of being pregnant (i.e., of childbearing age without effective contraception and without an HCG test)
  • Patient already enrolled in another therapeutic clinical trial or within the exclusion period of another clinical trial

Treatment and study plan

Neurostimulation

Procedure

Procedure guided by neurostimulation

Ultrasound

Procedure

Procedure guided by ultrasound

Primary outcomes

  1. Postoperative Pain assessment in the Post-Anesthesia Care Unit (PACU)

    Time frame: Hour 2

    The primary endpoint of the study is the maximum pain score in the Post-Anesthesia Care Unit (PACU) before morphine titration.

    Postoperative pain in the recovery room will be recorded by the nursing staff using a simple numeric scale from 0 to 10 after questioning the patient, following standard departmental procedures. The maximum pain score before morphine titration constitutes the primary evaluation criterion.

Secondary outcomes

  1. Quantitative Opioid Consumption

    Time frame: Hour 2

    Mean amount of morphine administered in each group

  2. Qualitative Opioid Consumption

    Time frame: Hour 2

    Percentage of patients in each group with zero morphine use

  3. Postoperative recovery assessment

    Time frame: Day 1

    QOR-15 accurately assesses postoperative recovery across five key domains: pain, physical comfort, physical independence, psychological support, and emotional state. Each item is rated from 0 (poor) to 10 (excellent), with a total score ranging from 0 (no recovery) to 150 (full recovery).

  4. Postoperative recovery assessment

    Time frame: Day 3

    QOR-15 accurately assesses postoperative recovery across five key domains: pain, physical comfort, physical independence, psychological support, and emotional state. Each item is rated from 0 (poor) to 10 (excellent), with a total score ranging from 0 (no recovery) to 150 (full recovery).

  5. Postoperative recovery assessment

    Time frame: Day 7

    QOR-15 accurately assesses postoperative recovery across five key domains: pain, physical comfort, physical independence, psychological support, and emotional state. Each item is rated from 0 (poor) to 10 (excellent), with a total score ranging from 0 (no recovery) to 150 (full recovery).

  6. Postoperative Pain assessment at rest

    Time frame: Day 1

    Postoperative pain will be measured by nursing staff during the patient's ambulatory stay, and the maximum score will be recorded in the Case Report Form (CRF). Pain will be self-reported by the patient using a simple numeric scale from 0 to 10.

  7. Postoperative Pain assessment at rest

    Time frame: Day 3

    Postoperative pain will be measured by nursing staff during the patient's ambulatory stay, and the maximum score will be recorded in the Case Report Form (CRF). Pain will be self-reported by the patient using a simple numeric scale from 0 to 10.

  8. Postoperative Pain assessment at rest

    Time frame: Day 7

    Postoperative pain will be measured by nursing staff during the patient's ambulatory stay, and the maximum score will be recorded in the Case Report Form (CRF). Pain will be self-reported by the patient using a simple numeric scale from 0 to 10.

  9. Postoperative Pain assessment during walking

    Time frame: Day 1

    Postoperative pain will be measured by nursing staff during the patient's ambulatory stay, and the maximum score will be recorded in the Case Report Form (CRF). Pain will be self-reported by the patient using a simple numeric scale from 0 to 10.

  10. Postoperative Pain assessment during walking

    Time frame: Day 3

    Postoperative pain will be measured by nursing staff during the patient's ambulatory stay, and the maximum score will be recorded in the Case Report Form (CRF). Pain will be self-reported by the patient using a simple numeric scale from 0 to 10.

  11. Postoperative Pain assessment during walking

    Time frame: Day 7

    Postoperative pain will be measured by nursing staff during the patient's ambulatory stay, and the maximum score will be recorded in the Case Report Form (CRF). Pain will be self-reported by the patient using a simple numeric scale from 0 to 10.

  12. Postoperative Pain assessment during First defecation

    Time frame: Day 7

    Postoperative pain will be measured by nursing staff during the patient's ambulatory stay, and the maximum score will be recorded in the Case Report Form (CRF). Pain will be self-reported by the patient using a simple numeric scale from 0 to 10.

  13. Non-Opioid Postoperative Medication Use

    Time frame: Day 1

    Use of non-opioid analgesics and antiemetics during hospitalization. Use of analgesics as reported by the patients.

  14. Pudendal block procedure duration

    Time frame: Hour 2

    Duration of pudendal block procedure

  15. Sensory block duration

    Time frame: Day 7

    Duration of sensory block

  16. Length of stay in the PACU

    Time frame: Day 1

    Length of stay in the PACU

  17. Total hospital stay duration

    Time frame: Day 1

    Total hospital stay duration

  18. Time to first defecation

    Time frame: Day 7

    Time to first defecation

  19. Tolerance

    Time frame: Day 7

    Procedure tolerance will be assessed by recording all adverse events (serious or non-serious) with a potential causal link to analgesia

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas GIRAL, MD

CONTACT

[email protected]

01 69 39 15 53 ext. 33

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: BACH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2025
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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