HemorrhoidsNCT05889962
Ultrasound-guided Pudendal Nerve Block for Pain After Hemorrhoidectomy
A study testing Pudendal nerve block in people with Hemorrhoids and Postoperative Pain, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to investigate the effects of ultrasound-guided pudendal nerve block on postoperative pain, opioid consumption, and quality of recovery in patients receiving Ferguson hemorrhoidectomy. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Hemorrhoids, Postoperative Pain
- What is being tested?
- Pudendal nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Oct 2023to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic hemorrhoids (grade III and grade IV internal hemorrhoids, mixed hemorrhoids, and external hemorrhoids)
- Age 20 to 65 years old
- American Society of Anesthesiologists (ASA) classification I~III
- Receiving Ferguson hemorrhoidectomy under spinal anesthesia
Who cannot join
- Allergy to local anesthetics or analgesics used in this study
- Drug abuse
- Coagulopathy
- An active infection at the injection site
- Patient refusal
- BMI ≥ 30
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Hospital
Taipei
Yuan-Wen Lee, MD, PhD, +886-2-27372181 ext. 8310, m102093020@tmu.edu.tw
About this study
Official title: Effects of Ultrasound-guided Pudendal Nerve Block on Postoperative Pain and Quality of Recovery in Patients Undergoing Hemorrhoidectomy
The goal of this clinical trial is to investigate the effects of ultrasound-guided pudendal nerve block on postoperative pain, opioid consumption, and quality of recovery in patients receiving Ferguson hemorrhoidectomy.
Read the detailed description
Patients who have symptomatic hemorrhoids undergoing Ferguson hemorrhoidectomy under spinal anesthesia will be randomized to receive bilateral ultrasound-guided pudendal nerve block with 0.5% ropivacaine or normal saline immediately after surgery. In addition, intravenous patient controlled analgesia, NSAIDs, and acetaminophen will be used in all participants for postoperative pain control. Postoperative pain on numerical rating scale (NRS), opioid consumption, quality of recovery (QOR-15), patient's satisfaction, and complications will be recorded at 6, 12, 24, 48 hours and 7 days after surgery.
- Conditions
- Hemorrhoids, Postoperative Pain
- Being tested
- Pudendal nerve block, Placebo block
- Medical subject headings
- Hemorrhoids, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pudendal nerve blockProcedure or surgery
Patients who are randomized in the pudendal block group will receive bilateral pudendal nerve block with ropivacaine.
Placebo blockProcedure or surgery
Patients who are randomized in the placebo group will receive bilateral pudendal block with normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Pudendal block group | Experimental | Receiving bilateral pudendal nerve block with 0.5% ropivacaine (10 ml each side) Receives: Procedure: Pudendal nerve block |
| Placebo group | Placebo comparator | Receiving bilateral pudendal nerve block with normal saline (10 ml each side) Receives: Procedure: Placebo block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score on the numeric rating scale (NRS) at baseline
NRS ranges from 0 (no pain) to 10 (worst pain)
Measured: Baseline
Postoperative pain score on the numeric rating scale (NRS) at 6 hours
NRS ranges from 0 (no pain) to 10 (worst pain)
Measured: 6 hours after hemorrhoidectomy
Postoperative pain score on the numeric rating scale (NRS) at 12 hours
NRS ranges from 0 (no pain) to 10 (worst pain)
Measured: 12 hours after hemorrhoidectomy
Postoperative pain score on the numeric rating scale (NRS) at 24 hours
NRS ranges from 0 (no pain) to 10 (worst pain)
Measured: 24 hours after hemorrhoidectomy
Postoperative pain score on the numeric rating scale (NRS) at 48 hours
NRS ranges from 0 (no pain) to 10 (worst pain)
Measured: 48 hours after hemorrhoidectomy
Postoperative pain score on the numeric rating scale (NRS) at 7 days
NRS ranges from 0 (no pain) to 10 (worst pain)
Measured: 7 days after hemorrhoidectomy
Opioid consumption at 6 hours
Morphine equivalent dose
Measured: 6 hours after hemorrhoidectomy
Opioid consumption at 12 hours
Morphine equivalent dose
Measured: 12 hours after hemorrhoidectomy
Opioid consumption at 24 hours
Morphine equivalent dose
Measured: 24 hours after hemorrhoidectomy
Opioid consumption at 48 hours
Morphine equivalent dose
Measured: 48 hours after hemorrhoidectomy
Opioid consumption at 7 days
Morphine equivalent dose
Measured: 7 days after hemorrhoidectomy
Quality of recovery at baseline
Quality of recovery-15 questionnaire measures the baseline quality of recovery
Measured: Baseline
Quality of recovery at 24 hours
Quality of recovery-15 questionnaire measures the quality of recovery after surgery
Measured: 24 hours after hemorrhoidectomy
Quality of recovery at 48 hours
Quality of recovery-15 questionnaire measures the quality of recovery after surgery
Measured: 48 hours after hemorrhoidectomy
Quality of recovery at 7 days
Quality of recovery-15 questionnaire measures the quality of recovery after surgery
Measured: 7 days after hemorrhoidectomy
Secondary outcomes (5)
Time to first rescue analgesics
Time after hemorrhoidectomy
Measured: Up to 7 days after hemorrhoidectomy
Time to the first urination
Time after hemorrhoidectomy
Measured: Up to 48 hours after hemorrhoidectomy
Time to the first defecation
Time after hemorrhoidectomy
Measured: Up to 48 hours after hemorrhoidectomy
Patient satisfaction with pain control
0 (worst) to 10 (Best)
Measured: 24 hours after hemorrhoidectomy
Postoperative complications
Pudendal nerve block related complications
Measured: Up to 7 days after hemorrhoidectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start26 Oct 2023
- Primary completionJul 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomly allocated into pudendal block group or placebo group. Pudendal block group: Patients will receive pudendal nerve block with ropivacaine. Placebo group: Patients will receive pudendal nerve block with normal saline.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuan-Wen Lee, MD, PhD, Principal investigator, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889962
- Sponsor's protocol ID
- N202303039
- Status last verified
- Jun 2023
- First submitted
- 2 May 2023
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ultrasound-guided Pudendal Nerve Block on Postoperative Pain and Quality of Recovery in Patients Undergoing Hemorrhoidectomy
- ClinicalTrials.gov ID
- NCT05889962
- Acronym / sponsor ID
- N202303039
- Conditions
- Hemorrhoids, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to investigate the effects of ultrasound-guided pudendal nerve block on postoperative pain, opioid consumption, and quality of recovery in patients receiving Ferguson hemorrhoidectomy.
Detailed description
Patients who have symptomatic hemorrhoids undergoing Ferguson hemorrhoidectomy under spinal anesthesia will be randomized to receive bilateral ultrasound-guided pudendal nerve block with 0.5% ropivacaine or normal saline immediately after surgery. In addition, intravenous patient controlled analgesia, NSAIDs, and acetaminophen will be used in all participants for postoperative pain control. Postoperative pain on numerical rating scale (NRS), opioid consumption, quality of recovery (QOR-15), patient's satisfaction, and complications will be recorded at 6, 12, 24, 48 hours and 7 days after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are randomly allocated into pudendal block group or placebo group. Pudendal block group: Patients will receive pudendal nerve block with ropivacaine. Placebo group: Patients will receive pudendal nerve block with normal saline.
| Arm | Type | Receives |
|---|---|---|
| Pudendal block group | Experimental | Procedure: Pudendal nerve blockReceiving bilateral pudendal nerve block with 0.5% ropivacaine (10 ml each side) |
| Placebo group | Placebo comparator | Procedure: Placebo blockReceiving bilateral pudendal nerve block with normal saline (10 ml each side) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with symptomatic hemorrhoids (grade III and grade IV internal hemorrhoids, mixed hemorrhoids, and external hemorrhoids)
- Age 20 to 65 years old
- American Society of Anesthesiologists (ASA) classification I~III
- Receiving Ferguson hemorrhoidectomy under spinal anesthesia
Key exclusion criteria (7 listed)
- Allergy to local anesthetics or analgesics used in this study
- Drug abuse
- Coagulopathy
- An active infection at the injection site
- Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pudendal nerve blockPatients who are randomized in the pudendal block group will receive bilateral pudendal nerve block with ropivacaine. | Procedure or surgery | Pudendal block group |
| Placebo blockPatients who are randomized in the placebo group will receive bilateral pudendal block with normal saline. | Procedure or surgery | Placebo group |
Primary outcome
Pain score on the numeric rating scale (NRS) at baseline
Time frame: Baseline
NRS ranges from 0 (no pain) to 10 (worst pain)
Postoperative pain score on the numeric rating scale (NRS) at 6 hours
Time frame: 6 hours after hemorrhoidectomy
NRS ranges from 0 (no pain) to 10 (worst pain)
Postoperative pain score on the numeric rating scale (NRS) at 12 hours
Time frame: 12 hours after hemorrhoidectomy
NRS ranges from 0 (no pain) to 10 (worst pain)
Postoperative pain score on the numeric rating scale (NRS) at 24 hours
Time frame: 24 hours after hemorrhoidectomy
NRS ranges from 0 (no pain) to 10 (worst pain)
Postoperative pain score on the numeric rating scale (NRS) at 48 hours
Time frame: 48 hours after hemorrhoidectomy
NRS ranges from 0 (no pain) to 10 (worst pain)
Postoperative pain score on the numeric rating scale (NRS) at 7 days
Time frame: 7 days after hemorrhoidectomy
NRS ranges from 0 (no pain) to 10 (worst pain)
Opioid consumption at 6 hours
Time frame: 6 hours after hemorrhoidectomy
Morphine equivalent dose
Opioid consumption at 12 hours
Time frame: 12 hours after hemorrhoidectomy
Morphine equivalent dose
Opioid consumption at 24 hours
Time frame: 24 hours after hemorrhoidectomy
Morphine equivalent dose
Opioid consumption at 48 hours
Time frame: 48 hours after hemorrhoidectomy
Morphine equivalent dose
Opioid consumption at 7 days
Time frame: 7 days after hemorrhoidectomy
Morphine equivalent dose
Quality of recovery at baseline
Time frame: Baseline
Quality of recovery-15 questionnaire measures the baseline quality of recovery
Quality of recovery at 24 hours
Time frame: 24 hours after hemorrhoidectomy
Quality of recovery-15 questionnaire measures the quality of recovery after surgery
Quality of recovery at 48 hours
Time frame: 48 hours after hemorrhoidectomy
Quality of recovery-15 questionnaire measures the quality of recovery after surgery
Quality of recovery at 7 days
Time frame: 7 days after hemorrhoidectomy
Quality of recovery-15 questionnaire measures the quality of recovery after surgery
5 secondary outcomes
Time to first rescue analgesics
Time frame: Up to 7 days after hemorrhoidectomy
Time to the first urination
Time frame: Up to 48 hours after hemorrhoidectomy
Time to the first defecation
Time frame: Up to 48 hours after hemorrhoidectomy
Patient satisfaction with pain control
Time frame: 24 hours after hemorrhoidectomy
Postoperative complications
Time frame: Up to 7 days after hemorrhoidectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuan-Wen Lee, MD, PhD principal investigator
Taipei Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pudendal nerve block in people with Hemorrhoids and Postoperative Pain, run by Taipei Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuan-Wen Lee, MD, PhD (+886-2-27372181 ext. 8310, m102093020@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score on the numeric rating scale (NRS) at baseline (time frame: Baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.