Postoperative pain following hemorrhoid removal surgery using a regional nerve block anesthesia with and without nerve stimulation

Clinical trial for the effectiveness of pudendal nerve block with and without neurostimulation for the reduction of posthemorroidectomy pain

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN22877737

Enrollment

Registered

2023-02-09

Start date

2020-06-01

Completion date

Unknown

Last updated

2023-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain in hemorrhoidectomy Not Applicable

Interventions

The present project proposes the performance of a single-center, triple-blind, randomized clinical trial of efficacy, carried out under conditions of routine clinical practice. The pu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Hemorrhoids refractory to medical treatment, grade III-IV symptomatic and grade II hemorrhoids that do not respond to conservative procedures (hemorrhoidal ligation/sclerosis) at Nuestra Señora de Candelaria Hospital 2. Outpatient surgery 3. Aged 18 years of age and over 4. Acceptance of the study and signature of the informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with inflammatory bowel disease 2. Concomitant anal pathology (fissure, fistula, etc) 3. Hemorrhoidal pathology with surgical indication other than the Ferguson technique 4. Chronic pain in treatment with morphine or derivatives 5. Paracetamol and NSAID allergy

Design outcomes

Primary

Measure	Time frame
Pain after hemorrhoidectomy measured using a verbal numerical scale one hour after the end of the surgery	—

Secondary

Measure	Time frame
1. Pain after hemorrhoidectomy measured using a telephone survey asking about the degree of pain (verbal numerical scale) 24 hours after the surgery and 7 days after the surgery 2. Need for rescue medication for pain control measured using a telephone survey asking about the need or not for additional medication (aids or others) 24 hours after the surgery and 7 days after the surgery 3. Constipation in posthemorroidectomy pain measured using the Bristol scale at 24 hours after the surgery and 7 days after the surgery 4. Patients' quality of life measured using the Short Health Scale Haemorrhoidal Disease (SHSHD) score questionnaire and 36-Item Short Form Survey (SF-36) at 24 hours after the surgery and 7 days after the surgery 5. Degree of satisfaction after the procedure measured in the consultation interview by asking the patient to rate the process from 1 to 10, one month after the surgery 6. Adverse events incidence measured using patient medical records. It is the investigator's responsibility to document all adverse events occurring during the clinical trial. At each visit/evaluation, all adverse events observed by either the investigator or one of his clinical collaborators, as well as those spontaneously reported by the subject, should be documented. The investigator will evaluate all adverse events and record them in the adverse events section of the subject's data collection notebook. Adverse events should be recorded at each evaluation visit throughout the study. The nature of each event, time of onset after administration of the drug or medical device, duration, severity and relationship to treatment should be stated. Details of any remedial treatment should be recorded on the appropriate pages of the data collection notebook. Initial symptomatology should be well documented at the screening visit.	—

Measure

Time frame

1. Pain after hemorrhoidectomy measured using a telephone survey asking about the degree of pain (verbal numerical scale) 24 hours after the surgery and 7 days after the surgery 2. Need for rescue medication for pain control measured using a telephone survey asking about the need or not for additional medication (aids or others) 24 hours after the surgery and 7 days after the surgery 3. Constipation in posthemorroidectomy pain measured using the Bristol scale at 24 hours after the surgery and 7 days after the surgery 4. Patients' quality of life measured using the Short Health Scale Haemorrhoidal Disease (SHSHD) score questionnaire and 36-Item Short Form Survey (SF-36) at 24 hours after the surgery and 7 days after the surgery 5. Degree of satisfaction after the procedure measured in the consultation interview by asking the patient to rate the process from 1 to 10, one month after the surgery 6. Adverse events incidence measured using patient medical records. It is the investigator's responsibility to document all adverse events occurring during the clinical trial. At each visit/evaluation, all adverse events observed by either the investigator or one of his clinical collaborators, as well as those spontaneously reported by the subject, should be documented. The investigator will evaluate all adverse events and record them in the adverse events section of the subject's data collection notebook. Adverse events should be recorded at each evaluation visit throughout the study. The nature of each event, time of onset after administration of the drug or medical device, duration, severity and relationship to treatment should be stated. Details of any remedial treatment should be recorded on the appropriate pages of the data collection notebook. Initial symptomatology should be well documented at the screening visit.

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Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026