SurgeryNCT06420388
2% Lidocaine Gel in Reducing Postoperative Pain Following Haemorrhoidectomy
A study testing 2% Lidocaine Gel, Water-based Lubricant Gel (K-Y Gel) and Standard Postoperative Analgesics in people with Surgery and Pain, Postoperative, run by E-DA Hospital at 1 site in Taiwan.
Trial summary
The study is a randomized, double-blind, controlled trial evaluating the efficacy of 2% lidocaine gel in reducing postoperative pain and analgesic consumption after haemorrhoidectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgery, Pain, Postoperative
- What is being tested?
- 2% Lidocaine Gel, Water-based Lubricant Gel (K-Y Gel) and Standard Postoperative Analgesics
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2023to 1 Oct 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Diagnosed with Grade III or IV hemorrhoids
- Candidate for Ferguson haemorrhoidectomy
Who cannot join
- Not a candidate for Ferguson haemorrhoidectomy
- Recurrent hemorrhoidal disease
- Concurrent anal pathology diagnosed preoperatively, including:
- Anal fistula
- Anal fissure
- Anal polyp
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- History of diabetes mellitus
- History of liver cirrhosis
- History of inflammatory bowel disease
- Documented neuropathy
- Coagulation disorders
- Currently on anticoagulants
- Documented allergy to any of the drugs included in the protocol
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
E-Da hospital
Kaohsiung City, 812
Chen Chih-I, +886978060015, ed111988@edah.org.tw
About this study
Official title: Efficacy of 2% Lidocaine Gel in Reducing Postoperative Pain and Analgesic Consumption Following Haemorrhoidectomy: A Randomized, Double-Blind, Controlled Trial
The study is a randomized, double-blind, controlled trial evaluating the efficacy of 2% lidocaine gel in reducing postoperative pain and analgesic consumption after haemorrhoidectomy. 222 patients undergoing Ferguson haemorrhoidectomy will be randomly assigned to receive either 2% lidocaine gel or a non-anaesthetic lubricant gel control. Pain scores using a visual analog scale (VAS) will be assessed at 12 and 24 hours, and 2, 3, and 7 days postoperatively. Analgesic consumption will also be measured.
Read the detailed description
Title: Efficacy of 2% Lidocaine Gel in Reducing Postoperative Pain and Analgesic Consumption Following Haemorrhoidectomy: A Randomized, Double-Blind, Controlled Trial Objective: To assess the effect of 2% lidocaine gel on postoperative pain intensity and analgesic consumption following haemorrhoidectomy.
Study Design: This study is a single-center, randomized, double-blind, controlled trial. Patients will be randomly assigned in a 1:1 ratio to receive either 2% lidocaine gel or a non-anaesthetic water-based lubricant gel (control) using a computer-generated randomization list. The randomization will be stratified by hemorrhoid grade (III or IV). The study medication will be prepared by the hospital pharmacy and provided in identical, pre-filled syringes to ensure blinding of participants and investigators.
Intervention: The intervention group will receive 5 mL of 2% lidocaine gel, while the control group will receive 5 mL of a non-anaesthetic water-based lubricant gel. The study medication will be applied to the perianal region three times per day for 7 days following surgery. Patients will be instructed on the proper application technique and will be provided with a diary to record the time and date of each application.
Outcome Assessment: Postoperative pain will be assessed using a 100 mm visual analog scale (VAS), with 0 representing no pain and 100 representing the worst imaginable pain. Pain scores will be recorded at 12 and 24 hours, and 2, 3, and 7 days after surgery. Patients will also record their analgesic consumption in a diary, including the type, dose, and frequency of analgesics used. Postoperative complications, such as bleeding, infection, or urinary retention, will be assessed by the treating surgeon at each follow-up visit.
Sample Size: A sample size of 222 patients (111 per group) was calculated based on a power of 80%, a significance level of 0.05, and an expected difference in mean VAS scores of 15 mm between the groups, with a standard deviation of 30 mm.
- Conditions
- Surgery, Pain, Postoperative
- Being tested
- 2% Lidocaine Gel, Water-based Lubricant Gel (K-Y Gel), Standard Postoperative Analgesics
- Keywords
- hemorrhoids, pain management
- Medical subject headings
- Pain, Postoperative, Hemorrhoids, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% Lidocaine GelDrug
The intervention group received 5 mL of 2% lidocaine gel applied topically 3 times per day after undergoing Ferguson hemorrhoidectomy surgery.
The control group received 5 mL of a non-anesthetic water-based lubricant gel applied topically 3 times per day after surgery.
The application of the gels began immediately after surgery and continued for the postoperative period evaluated in the study.
Both groups received standard postoperative analgesics (acetaminophen, celecoxib, Dynastat/parecoxib as needed) in addition to the topical gel applications.
Water-based Lubricant Gel (K-Y Gel)Drug
The intervention group received 5 mL of mL of a non-anesthetic water-based lubricant gel (K-Y gel) applied topically 3 times per day after undergoing Ferguson hemorrhoidectomy surgery.
Standard Postoperative AnalgesicsDrug
Acetaminophen (Paracetamol)
Dosage: 500 mg per tablet Frequency: Every 6 hours Route: Oral
Acetaminophen is a common over-the-counter pain reliever and fever reducer. It works by blocking the production of prostaglandins, which are responsible for causing pain and inflammation.
Celecoxib
Dosage: 200 mg per tablet Frequency: Every 12 hours Route: Oral
Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that specifically inhibits the cyclooxygenase-2 enzyme. By reducing the production of prostaglandins, celecoxib helps alleviate pain and inflammation.
Dynastat (Parecoxib)
Dosage: 40 mg per injection Frequency: Every 12 hours as needed for poorly controlled pain Route: Intravenous
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Gel | Experimental | Description: Patients in this group received 5 mL of 2% lidocaine gel applied to the perianal region three times per day postoperatively. The gel was self-administered by the patient or applied by a nurse if the patient was unable to do so. Treatment continued for 7 days after the haemorrhoidectomy procedure.
Arm Sample Size: 200 Receives: Drug: 2% Lidocaine Gel; Drug: Standard Postoperative Analgesics |
| Controlled | Placebo comparator | Description: Patients in this group received 5 mL of a non-anaesthetic, water-based lubricant gel (K-Y gel) applied to the perianal region three times per day postoperatively. The gel was self-administered by the patient or applied by a nurse if the patient was unable to do so. Treatment continued for 7 days after the haemorrhoidectomy procedure. This group served as a control to compare the efficacy of 2% lidocaine gel in reducing postoperative pain and analgesic consumption.
Arm Sample Size: 200 Receives: Drug: Water-based Lubricant Gel (K-Y Gel); Drug: Standard Postoperative Analgesics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain measured by Visual Analog Scale (VAS) The Visual Analog Scale (VAS) is a unidimensional measure of pain intensity. Patients mark their pain level on a 10-cm line, where 0 represents "no pain" and 10 represents "the worst pain imaginable". Higher scores indicate greater pain intensity.
Measured: Assessed at 12 hours, 24 hours, 2 days, 3 days, and 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 May 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- This study is a single-center, randomized, double-blind, controlled clinical trial comparing the efficacy of 2% lidocaine gel versus a non-anaesthetic lubricant gel control in reducing postoperative pain and analgesic consumption following haemorrhoidectomy. Patients were randomly assigned in a 1:1 ratio to either the intervention group receiving 5 mL 2% lidocaine gel three times per day postoperatively or the control group receiving 5 mL of a non-anaesthetic water-based lubricant gel.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- E-DA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen Chih-I, Study director, E-DA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420388
- Sponsor's protocol ID
- EMRP28112N
- Status last verified
- May 2024
- First submitted
- 12 May 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study is a randomized, double-blind, controlled trial evaluating the efficacy of 2% lidocaine gel in reducing postoperative pain and analgesic consumption after haemorrhoidectomy. 222 patients undergoing Ferguson haemorrhoidectomy were randomly assigned to receive either 2% lidocaine gel or a non-anaesthetic lubricant gel control. Pain scores using a visual analog scale (VAS) were assessed at 12 and 24 hours, and 2, 3, and 7 days postoperatively. Analgesic consumption was also measured.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 2% Lidocaine Gel in Reducing Postoperative Pain and Analgesic Consumption Following Haemorrhoidectomy: A Randomized, Double-Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT06420388
- Acronym / sponsor ID
- EMRP28112N
- Conditions
- Surgery, Pain, Postoperative
- Keywords
- hemorrhoids, pain management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- E-DA HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 20 May 2024 (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 study is a randomized, double-blind, controlled trial evaluating the efficacy of 2% lidocaine gel in reducing postoperative pain and analgesic consumption after haemorrhoidectomy. 222 patients undergoing Ferguson haemorrhoidectomy will be randomly assigned to receive either 2% lidocaine gel or a non-anaesthetic lubricant gel control. Pain scores using a visual analog scale (VAS) will be assessed at 12 and 24 hours, and 2, 3, and 7 days postoperatively. Analgesic consumption will also be measured.
Detailed description
Title: Efficacy of 2% Lidocaine Gel in Reducing Postoperative Pain and Analgesic Consumption Following Haemorrhoidectomy: A Randomized, Double-Blind, Controlled Trial Objective: To assess the effect of 2% lidocaine gel on postoperative pain intensity and analgesic consumption following haemorrhoidectomy.
Study Design: This study is a single-center, randomized, double-blind, controlled trial. Patients will be randomly assigned in a 1:1 ratio to receive either 2% lidocaine gel or a non-anaesthetic water-based lubricant gel (control) using a computer-generated randomization list. The randomization will be stratified by hemorrhoid grade (III or IV). The study medication will be prepared by the hospital pharmacy and provided in identical, pre-filled syringes to ensure blinding of participants and investigators.
Intervention: The intervention group will receive 5 mL of 2% lidocaine gel, while the control group will receive 5 mL of a non-anaesthetic water-based lubricant gel. The study medication will be applied to the perianal region three times per day for 7 days following surgery. Patients will be instructed on the proper application technique and will be provided with a diary to record the time and date of each application.
Outcome Assessment: Postoperative pain will be assessed using a 100 mm visual analog scale (VAS), with 0 representing no pain and 100 representing the worst imaginable pain. Pain scores will be recorded at 12 and 24 hours, and 2, 3, and 7 days after surgery. Patients will also record their analgesic consumption in a diary, including the type, dose, and frequency of analgesics used. Postoperative complications, such as bleeding, infection, or urinary retention, will be assessed by the treating surgeon at each follow-up visit.
Sample Size: A sample size of 222 patients (111 per group) was calculated based on a power of 80%, a significance level of 0.05, and an expected difference in mean VAS scores of 15 mm between the groups, with a standard deviation of 30 mm.
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
- This study is a single-center, randomized, double-blind, controlled clinical trial comparing the efficacy of 2% lidocaine gel versus a non-anaesthetic lubricant gel control in reducing postoperative pain and analgesic consumption following haemorrhoidectomy. Patients were randomly assigned in a 1:1 ratio to either the intervention group receiving 5 mL 2% lidocaine gel three times per day postoperatively or the control group receiving 5 mL of a non-anaesthetic water-based lubricant gel.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Gel | Experimental | Drug: 2% Lidocaine Gel, Drug: Standard Postoperative AnalgesicsDescription: Patients in this group received 5 mL of 2% lidocaine gel applied to the perianal region three times per day postoperatively. The gel was self-administered by the patient or applied by a nurse if the patient was unable to do so. Treatment continued for 7 days after the haemorrhoidectomy procedure. Arm Sample Size: 200 |
| Controlled | Placebo comparator | Drug: Water-based Lubricant Gel (K-Y Gel), Drug: Standard Postoperative AnalgesicsDescription: Patients in this group received 5 mL of a non-anaesthetic, water-based lubricant gel (K-Y gel) applied to the perianal region three times per day postoperatively. The gel was self-administered by the patient or applied by a nurse if the patient was unable to do so. Treatment continued for 7 days after the haemorrhoidectomy procedure. This group served as a control to compare the efficacy of 2% lidocaine gel in reducing postoperative pain and analgesic consumption. Arm Sample Size: 200 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Diagnosed with Grade III or IV hemorrhoids
- Candidate for Ferguson haemorrhoidectomy
Key exclusion criteria (13 listed)
- Not a candidate for Ferguson haemorrhoidectomy
- Recurrent hemorrhoidal disease
- Concurrent anal pathology diagnosed preoperatively, including:
- Anal fistula
- Anal fissure
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 |
|---|---|---|
| 2% Lidocaine GelThe intervention group received 5 mL of 2% lidocaine gel applied topically 3 times per day after undergoing Ferguson hemorrhoidectomy surgery. The control group received 5 mL of a non-anesthetic water-based lubricant gel applied topically 3 times per day after surgery. The application of the gels began immediately after surgery and continued for the postoperative period evaluated in the study. Both groups received standard postoperative analgesics (acetaminophen, celecoxib, Dynastat/parecoxib as needed) in addition to the topical gel applications. | Drug | Lidocaine Gel |
| Water-based Lubricant Gel (K-Y Gel)The intervention group received 5 mL of mL of a non-anesthetic water-based lubricant gel (K-Y gel) applied topically 3 times per day after undergoing Ferguson hemorrhoidectomy surgery. | Drug | Controlled |
| Standard Postoperative AnalgesicsAcetaminophen (Paracetamol) Dosage: 500 mg per tablet Frequency: Every 6 hours Route: Oral Acetaminophen is a common over-the-counter pain reliever and fever reducer. It works by blocking the production of prostaglandins, which are responsible for causing pain and inflammation. Celecoxib Dosage: 200 mg per tablet Frequency: Every 12 hours Route: Oral Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that specifically inhibits the cyclooxygenase-2 enzyme. By reducing the production of prostaglandins, celecoxib helps alleviate pain and inflammation. Dynastat (Parecoxib) Dosage: 40 mg per injection Frequency: Every 12 hours as needed for poorly controlled pain Route: Intravenous | Drug | Controlled, Lidocaine Gel |
Primary outcome
Postoperative pain
Time frame: Assessed at 12 hours, 24 hours, 2 days, 3 days, and 7 days after surgery
Postoperative pain measured by Visual Analog Scale (VAS) The Visual Analog Scale (VAS) is a unidimensional measure of pain intensity. Patients mark their pain level on a 10-cm line, where 0 represents "no pain" and 10 represents "the worst pain imaginable". Higher scores indicate greater pain intensity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: Yes. The study is a randomized, double-blind, controlled trial evaluating the efficacy of 2% lidocaine gel in reducing postoperative pain and analgesic consumption after haemorrhoidectomy. 222 patients undergoing Ferguson haemorrhoidectomy were randomly assigned to receive either 2% lidocaine gel or a non-anaesthetic lubricant gel control. Pain scores using a visual analog scale (VAS) were assessed at 12 and 24 hours, and 2, 3, and 7 days postoperatively. Analgesic consumption was also measured.
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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.
Chen Chih-I study director
E-DA 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 2% Lidocaine Gel, Water-based Lubricant Gel (K-Y Gel) and Standard Postoperative Analgesics in people with Surgery and Pain, Postoperative, run by E-DA 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 3 inclusion and 13 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 12 Jun 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 Chen Chih-i (+886978060015, ed111988@edah.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: Assessed at 12 hours, 24 hours, 2 days, 3 days, and 7 days after surgery). 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 12 Jun 2024.