Hemorrhoids, Postoperative Pain
Conditions
Brief summary
Patients undergoing Milligan-Morgan hemorrhoidectomy will be randomized to receive or not the pudendal nerve block after the spinal anesthesia.
Detailed description
Patients included were those undergoing Milligan-Morgan hemorrhoidectomy under spinal anaesthesia from January 2018 to December 2019. Exclusion criteria were age \< 18 years old, pregnancy and allergy to local anaesthetics. Patients meeting inclusion and exclusion criteria were randomized to undergo an ultrasound-guided pudendal nerve block. Per-protocol all patients received postoperative metronidazole 500 mg for 3 days, laxative, a basis analgesia with NSAID and opioids as needed. Postoperative pain on the visual analogue scale (VAS) at 6, 12, 24 and 48 hours, opioids needed, complications and length of hospital stay were recorded. Patients and ward personnel were not informed about the treatment arm. All Patients were further controlled 6 weeks after the intervention.
Interventions
PROCEDURELocal anesthetic (ropivacaine)
Patients randomized in the treatment arm will receive a sonography-guided pudendal nerve block
Sponsors
Francesco Mongelli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients affected by haemorrhoids (grade III and IV) and treated with Milligan-Morgan hemorrhoidectomy under spinal anaesthesia * Signed informed consent
Exclusion criteria
* Age \< 18 years old * Pregnancy * Allergy to local anaesthetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain on the Visual Analogue Scale (VAS) | at 24 hours after the hemorrhoidectomy | Visual analogue scale (VAS) ranges from 0 to 10, where 0 is no pain at all and 10 is the strongest pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications Related to the Pudendal Nerve Block | Within 6 weeks | — |
| Direct and Indirect Cost Analysis in Out- and In-patients | Within the hospital stay | Ongoing |
| Postoperative Pain on the Visual Analogue Scale (VAS) | at 6, 12 and 48 hours after the operation | Visual analogue scale (VAS) ranges from 0 to 10, where 0 is no pain at all and 10 is the strongest pain |
| Opioids Consumption | Within 48 hours | — |
| Lenght of Hospital Stay | up to 2 weeks | — |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Receiving the Pudendal Nerve Block Ultrasound-guided pudendal nerve block performed with 20 mls Ropivacaine 0.75%. | 23 |
| Not Receiving the Pudendal Nerve Block No ultrasound-guided pudendal nerve block performed. | 26 |
| Total | 49 |
Baseline characteristics
| Characteristic | Receiving the Pudendal Nerve Block | Not Receiving the Pudendal Nerve Block | Total |
|---|---|---|---|
| Age, Continuous | 51.6 years STANDARD_DEVIATION 18.3 | 53.3 years STANDARD_DEVIATION 17.5 | 52.5 years STANDARD_DEVIATION 17.7 |
| Comorbidities (Cardiologic, Pulmonary, Kidney, Diabetes, Neuropathy) • Cardiologic disease | 2 participants | 3 participants | 5 participants |
| Comorbidities (Cardiologic, Pulmonary, Kidney, Diabetes, Neuropathy) • Diabetes | 1 participants | 2 participants | 3 participants |
| Comorbidities (Cardiologic, Pulmonary, Kidney, Diabetes, Neuropathy) • Kidney disease | 2 participants | 1 participants | 3 participants |
| Comorbidities (Cardiologic, Pulmonary, Kidney, Diabetes, Neuropathy) • Neuropathy | 0 participants | 1 participants | 1 participants |
| Comorbidities (Cardiologic, Pulmonary, Kidney, Diabetes, Neuropathy) • Pulmonary disease | 0 participants | 3 participants | 3 participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Switzerland | 23 Participants | 26 Participants | 49 Participants |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Male | 12 Participants | 15 Participants | 27 Participants |
| Symptoms leading to surgery (itching, pain, bleeding, tenesmus) Bleeding | 12 participants | 19 participants | 31 participants |
| Symptoms leading to surgery (itching, pain, bleeding, tenesmus) Itching | 10 participants | 9 participants | 19 participants |
| Symptoms leading to surgery (itching, pain, bleeding, tenesmus) Pain | 20 participants | 23 participants | 43 participants |
| Symptoms leading to surgery (itching, pain, bleeding, tenesmus) Tenesmus | 2 participants | 2 participants | 4 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 26 |
| other Total, other adverse events | 0 / 23 | 0 / 26 |
| serious Total, serious adverse events | 0 / 23 | 0 / 26 |
Outcome results
Primary
Postoperative Pain on the Visual Analogue Scale (VAS)
Visual analogue scale (VAS) ranges from 0 to 10, where 0 is no pain at all and 10 is the strongest pain
Time frame: at 24 hours after the hemorrhoidectomy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Receiving the Pudendal Nerve Block | Postoperative Pain on the Visual Analogue Scale (VAS) | 1.4 units on a scale | Standard Deviation 1.4 |
| Not Receiving the Pudendal Nerve Block | Postoperative Pain on the Visual Analogue Scale (VAS) | 3.1 units on a scale | Standard Deviation 2.4 |
Secondary
Complications Related to the Pudendal Nerve Block
Time frame: Within 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Receiving the Pudendal Nerve Block | Complications Related to the Pudendal Nerve Block | 0 Participants |
| Not Receiving the Pudendal Nerve Block | Complications Related to the Pudendal Nerve Block | 0 Participants |
Secondary
Direct and Indirect Cost Analysis in Out- and In-patients
Ongoing
Time frame: Within the hospital stay
Secondary
Lenght of Hospital Stay
Time frame: up to 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Receiving the Pudendal Nerve Block | Lenght of Hospital Stay | 1.2 days | Standard Deviation 1.2 |
| Not Receiving the Pudendal Nerve Block | Lenght of Hospital Stay | 1.8 days | Standard Deviation 1.8 |
Secondary
Opioids Consumption
Time frame: Within 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Receiving the Pudendal Nerve Block | Opioids Consumption | 5 Participants |
| Not Receiving the Pudendal Nerve Block | Opioids Consumption | 10 Participants |
Secondary
Postoperative Pain on the Visual Analogue Scale (VAS)
Visual analogue scale (VAS) ranges from 0 to 10, where 0 is no pain at all and 10 is the strongest pain
Time frame: at 6, 12 and 48 hours after the operation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Receiving the Pudendal Nerve Block | Postoperative Pain on the Visual Analogue Scale (VAS) | Pain on VAS at 6 hours | 2.8 score on a scale | Standard Deviation 2.4 |
| Receiving the Pudendal Nerve Block | Postoperative Pain on the Visual Analogue Scale (VAS) | Pain on VAS at 12 hours | 3.4 score on a scale | Standard Deviation 3.1 |
| Receiving the Pudendal Nerve Block | Postoperative Pain on the Visual Analogue Scale (VAS) | Pain on VAS at 48 hours | 1.0 score on a scale | Standard Deviation 1.6 |
| Not Receiving the Pudendal Nerve Block | Postoperative Pain on the Visual Analogue Scale (VAS) | Pain on VAS at 12 hours | 4.7 score on a scale | Standard Deviation 3.6 |
| Not Receiving the Pudendal Nerve Block | Postoperative Pain on the Visual Analogue Scale (VAS) | Pain on VAS at 6 hours | 4.6 score on a scale | Standard Deviation 3.7 |
| Not Receiving the Pudendal Nerve Block | Postoperative Pain on the Visual Analogue Scale (VAS) | Pain on VAS at 48 hours | 2.1 score on a scale | Standard Deviation 2 |