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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
202
Procedure guided by neurostimulation
Procedure guided by ultrasound
Hôpital Privé Claude Galien
Quincy-sous-Sénart, France
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
Quantitative Opioid Consumption
Mean amount of morphine administered in each group
Time frame: Hour 2
Qualitative Opioid Consumption
Percentage of patients in each group with zero morphine use
Time frame: Hour 2
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
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
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 7
Postoperative Pain assessment at rest
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.
Time frame: Day 1
Postoperative Pain assessment at rest
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.
Time frame: Day 3
Postoperative Pain assessment at rest
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.
Time frame: Day 7
Postoperative Pain assessment during walking
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.
Time frame: Day 1
Postoperative Pain assessment during walking
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.
Time frame: Day 3
Postoperative Pain assessment during walking
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.
Time frame: Day 7
Postoperative Pain assessment during First defecation
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.
Time frame: Day 7
Non-Opioid Postoperative Medication Use
Use of non-opioid analgesics and antiemetics during hospitalization. Use of analgesics as reported by the patients.
Time frame: Day 1
Pudendal block procedure duration
Duration of pudendal block procedure
Time frame: Hour 2
Sensory block duration
Duration of sensory block
Time frame: Day 7
Length of stay in the PACU
Length of stay in the PACU
Time frame: Day 1
Total hospital stay duration
Total hospital stay duration
Time frame: Day 1
Time to first defecation
Time to first defecation
Time frame: Day 7
Tolerance
Procedure tolerance will be assessed by recording all adverse events (serious or non-serious) with a potential causal link to analgesia
Time frame: Day 7
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