Hemorrhoids
Conditions
Keywords
hemorroidal surgery
Brief summary
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).
Detailed description
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.
Interventions
PROCEDURENeurostimulation
Procedure guided by neurostimulation
PROCEDUREUltrasound
Procedure guided by ultrasound
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain assessment in the Post-Anesthesia Care Unit (PACU) | 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
| Measure | Time frame | Description |
|---|---|---|
| Sensory block duration | Day 7 | Duration of sensory block |
| Length of stay in the PACU | Day 1 | Length of stay in the PACU |
| Total hospital stay duration | Day 1 | Total hospital stay duration |
| Time to first defecation | Day 7 | Time to first defecation |
| Quantitative Opioid Consumption | Hour 2 | Mean amount of morphine administered in each group |
| Qualitative Opioid Consumption | Hour 2 | Percentage of patients in each group with zero morphine use |
| Pudendal block procedure duration | Hour 2 | Duration of pudendal block procedure |
| Non-Opioid Postoperative Medication Use | Day 1 | Use of non-opioid analgesics and antiemetics during hospitalization. Use of analgesics as reported by the patients. |
| Postoperative Pain assessment at rest | 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. |
| Postoperative Pain assessment during walking | 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. |
| Postoperative Pain assessment during First defecation | 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. |
| Tolerance | Day 7 | Procedure tolerance will be assessed by recording all adverse events (serious or non-serious) with a potential causal link to analgesia |
| Postoperative recovery assessment | 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). |
Countries
France
Contacts
Primary ContactThomas GIRAL, MD
Outcome results
None listed