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

ConditionHemorrhoids
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neurostimulation

    Procedure/Surgery

    Procedure guided by neurostimulation

  • Ultrasound

    Procedure/Surgery

    Procedure guided by ultrasound

Treatment groups

202 Participants
are divided into 2 treatment groups
Group A: Pudendal block guided by neurostimulationActive comparator 1 intervention
Group B: Pudendal block guided by ultrasoundExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
Hour 2

Secondary outcomes

1

Quantitative Opioid Consumption

Mean amount of morphine administered in each group

Time frame
Hour 2
2

Qualitative Opioid Consumption

Percentage of patients in each group with zero morphine use

Time frame
Hour 2
3

Postoperative recovery assessment

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).

Time frame
Day 1
4

Postoperative recovery assessment

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).

Time frame
Day 3

Other outcomes

Sponsors and contacts

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