Pain ManagementPhase 4NCT07688031
Topical Lidocaine 23%/Tetracaine 7% Ointment for Post-Hemorrhoidectomy Analgesia: A Randomized Controlled Trial
A Phase 4 study testing Lidocaine 23% / Tetracaine 7% topical ointment (compounded) in people with Pain Management and Hemorrhoids Third Degree, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
The goal of this clinical trial is to learn if a topical ointment containing two local anesthetics (lidocaine 23% and tetracaine 7%) can reduce pain after hemorrhoid surgery in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management, Hemorrhoids Third Degree, Hemorrhoids Fourth Degree
- What is being tested?
- Lidocaine 23% / Tetracaine 7% topical ointment (compounded)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteChile
- Study dates
- 24 May 2023to 12 May 2026
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Scheduled for elective hemorrhoidectomy
- Recruited consecutively on the day of surgery
- Able to provide written informed consent
Who cannot join
- Inflammatory bowel disease
- Immunosuppression
- Pregnancy
- Chronic pain requiring ongoing analgesic treatment
- Known hypersensitivity to any of the study medications
- Significant cardiovascular disease
Show all 10Show fewer
- Peripheral vascular disease
- Cerebrovascular disease
- Hepatic disease
- Seizure disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Topical Lidocaine 23%/Tetracaine 7% Ointment Versus Placebo for Post-Hemorrhoidectomy Pain: A Double-Blind Randomized Controlled Trial
The goal of this clinical trial is to learn if a topical ointment containing two local anesthetics (lidocaine 23% and tetracaine 7%) can reduce pain after hemorrhoid surgery in adults. The main questions it aims to answer are:
- Does the ointment lower post-defecation pain movements in the first 10 days after surgery?
- Does the ointment lower overall daily pain in the 10 days after surgery?
- Does the ointment reduce the need for rescue pain medication (tramadol)?
Read more
Researchers will compare the lidocaine/tetracaine ointment to a placebo (a look-alike ointment that contains no active drug) to see if the active ointment works better to reduce pain after hemorrhoid surgery.
Participants will:
- Apply the ointment or placebo to the anal area every 12 hours for 10 days after surgery
- Rate their pain on a scale from 0 to 10 each day, including pain after bowel movements/defecation
- Record how many times they take rescue pain medication each day
- Receive check-in calls/mesages from the research team after surgery
Read the detailed description
Background
Hemorrhoidectomy is the most effective surgical treatment for advanced hemorrhoidal disease, but it is associated with significant postoperative pain, particularly during bowel movements. Standard multimodal analgesia regimens, including scheduled non-steroidal anti-inflammatory drugs, acetaminophen, and opioid rescue doses, often provide incomplete relief, especially during defecation. Topical local anesthetics have been explored as adjuvant analgesic agents in this setting, but commercially available formulations use low concentrations (typically 2-2.5%) that may limit their efficacy. High-concentration compounded formulations containing lidocaine 23% and tetracaine 7% have demonstrated an adequate pharmacokinetic safety profile in other clinical settings, but had not been evaluated in proctological surgery prior to this trial.
Study Design
This was a single-center, double-blind, placebo-controlled randomized controlled trial (RCT) conducted at a private academic institution in Santiago, Chile. Participants were randomized in a 1:1 ratio to receive either active ointment (lidocaine 23%/tetracaine 7%) or an identical-appearing placebo ointment. Randomization was performed using a computer-generated sequence with allocation concealment via an encrypted randomization. Both participants and the surgical team were blinded to treatment allocation throughout the follow-up period. The ointments were prepared and labeled by an independent compounding pharmacy, and were identical in color, texture, and packaging.
Intervention
Participants in the intervention group applied approximately 2 g of the lidocaine 23%/tetracaine 7% ointment to the perianal area every 12 hours, beginning on the day of surgery (postoperative day 0) and continuing through postoperative day 10. Participants in the control group applied an identical-appearing placebo ointment following the same schedule. All participants received a standardized perioperative analgesic protocol consisting of scheduled oral ketorolac and acetaminophen, with oral tramadol (25 mg per dose) as rescue analgesia available on demand. Surgical technique was standardized across participating surgeons; trainees operated under direct supervision of board-certified colorectal surgeons.
Outcomes and Measurements
Pain was assessed using a 0-10 visual analogue scale (VAS). Two pain dimensions were recorded daily by participants in a structured paper diary. Post-defecatory pain was recorded as a VAS score immediately after each bowel movement; on days with more than one bowel movement, the mean score was used; on days without a bowel movement, no score was recorded for this dimension. Mean daily pain was recorded as the average VAS score across the entire day, noted each evening. Rescue opioid use was recorded daily as the number of tramadol doses taken. Adverse events were recorded at each follow-up contact and at the end of the 10-day period. Follow-up was conducted by a dedicated research assistant via telephone and messages. Participants were also asked to return their completed diary at the day-10 contact.
Sample Size
Sample size was calculated to detect a clinically relevant 25% reduction in post-defecatory pain, assuming a mean VAS score of 6.6 (SD 2.2), with a two-sided significance level of 0.05 and 80% power, yielding 56 evaluable participants (28 per group). Accounting for an anticipated 10% loss to follow-up, target enrollment was set at 62 patients.
Statistical Analysis
All analyses were performed on an intention-to-treat basis. Continuous variables were compared using the independent samples Student's t-test after confirming normality with the Shapiro-Wilk test and homogeneity of variance with Levene's test. The t-test with equal variances assumed was applied consistently across all time points of each outcome variable to maintain methodological consistency. Categorical variables were compared using Pearson's chi-square test. Period averages for post-defecatory pain (days 1-5 and days 1-10) were calculated as the mean of available daily scores per participant. Daily mean overall pain for the 10-day period was calculated from the pre-specified composite variable. Statistical significance was set at p < 0.05 (two-tailed). All analyses were performed using IBM SPSS Statistics version 29.
Safety Considerations
Prior to trial design, the pharmacokinetic profile of the lidocaine 23%/tetracaine 7% formulation was reviewed. Published data indicate that peak plasma lidocaine concentrations remain below the recognized toxicity threshold of 2 mcg/mL when the formulation is applied to surface areas under 250 cm². In this trial, participants applied approximately 2 g to a perianal surface area of 10-30 cm², representing a substantially lower dose than those associated with systemic toxicity. Participants with conditions associated with increased risk of local anesthetic toxicity (significant cardiovascular, cerebrovascular, or hepatic disease; seizure disorders) were excluded from enrollment. Plasma lidocaine levels were not routinely measured given the low dose used.
- Conditions
- Pain Management, Hemorrhoids Third Degree, Hemorrhoids Fourth Degree, Hemorrhoids Second Degree
- Being tested
- Lidocaine 23% / Tetracaine 7% topical ointment (compounded), Placebo ointment
- Keywords
- Hemorrhoidectomy, Postoperative pain, Topical analgesia, Lidocaine, Opioid-sparing, Anorectal surgery, Pain management
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 23% / Tetracaine 7% topical ointment (compounded)Drug
Compounded topical ointment containing lidocaine 23% and tetracaine 7%, prepared by an independent compounding pharmacy. Approximately 2 g applied to the perianal area every 12 hours from postoperative day 0 through day 10.
Placebo ointmentOther
Inert topical ointment identical in appearance, color, texture, and packaging to the active intervention, prepared by the same independent compounding pharmacy. Applied following the same schedule as the active ointment
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine/Tetracaine Ointment | Experimental | Participants applied approximately 2 g of compounded lidocaine 23%/tetracaine 7% ointment to the perianal area every 12 hours, beginning on the day of surgery (postoperative day 0) and continuing through postoperative day 10. All participants also received a standardized perioperative analgesic protocol consisting of scheduled oral ketorolac and acetaminophen, with oral tramadol 25 mg per dose available on demand as rescue analgesia. Receives: Drug: Lidocaine 23% / Tetracaine 7% topical ointment (compounded) |
| Placebo | Placebo comparator | Participants applied an identical-appearing placebo ointment to the perianal area every 12 hours following the same schedule as the intervention group (postoperative days 0 to 10). The placebo was prepared by the same independent compounding pharmacy and was identical in color, texture, and packaging to the active ointment. All participants also received the same standardized perioperative analgesic protocol consisting of scheduled oral ketorolac and acetaminophen, with oral tramadol 25 mg per dose available on demand as rescue analgesia. Receives: Other: Placebo ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-defecatory pain score during the first 10 postoperative days
Self-reported post-defecatory pain intensity assessed using a 0-10 visual analogue scale (VAS), recorded by participants immediately after each bowel movement. The primary outcome is the mean of available daily post-defecatory VAS scores across postoperative days 1 through 10. On days with more than one bowel movement, the daily score represents the mean of all recordings. Days without a bowel movement are excluded from the calculation.
Measured: Postoperative days 1 through 10
Secondary outcomes (6)
Mean daily pain score
Mean overall daily pain intensity assessed using a 0-10 VAS, recorded each evening by participants as a global rating of pain experienced throughout the day, across postoperative days 1 through 10.
Measured: Postoperative days 1 through 10
Cumulative rescue opioid consumption
Total number of tramadol 25 mg doses taken over the 10-day follow-up period, recorded daily in the pain diary. Missing daily entries are treated as zero doses.
Measured: Postoperative days 1 through 10
Adverse effects related to the study ointment
Incidence and nature of adverse events potentially attributable to the topical ointment, including local reactions (pruritus, burning, skin irritation) and systemic symptoms (nausea, headache, dizziness). Recorded at each follow-up contact on postoperative days 1, 3, 6, and 10.
Measured: Postoperative days 0 through 10
Postoperative complications within 30 days
Incidence of surgical complications within 30 days of hemorrhoidectomy, including bleeding, infection, urinary retention, and unplanned return to the operating room.
Measured: 30 days postoperatively
Mean post-defecatory pain score during postoperative days 1-5
Mean post-defecatory VAS score (0-10) calculated across postoperative days 1 through 5, as a pre-specified exploratory subperiod analysis.
Measured: Postoperative days 1 through 5
Mean daily pain score during postoperative days 1-5
Mean overall daily VAS score (0-10) calculated across postoperative days 1 through 5, as a pre-specified exploratory subperiod analysis.
Measured: Postoperative days 1 through 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start24 May 2023
- Primary completion9 Oct 2025
- Study completion12 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Chilena de Coloproctología
- Responsible party
- Principal investigator, Felipe Bellolio Roth, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688031
- Sponsor's protocol ID
- 220531005
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The institutional review board and research ethics committee that approved this study (Protocol ID: 220531005) does not authorize the export or transfer of clinical data outside the approved research context. The committee assumes no responsibility for data use beyond the scope of the original protocol and permits access to clinical data only upon formal written request and explicit authorization by the ethics committee.
Publications
Bikfalvi A, Faes C, Freys SM, Joshi GP, Van de Velde M, Albrecht E. PROSPECT guideline for haemorrhoid surgery: A systematic review and procedure-specific postoperative pain management recommendations. Eur J Anaesthesiol Intensive Care. 2023 May 26;2(3):e0023. doi: 10.1097/EA9.0000000000000023. eCollection 2023 Jun.
PubMed 39917290Chen H, Zhang W, Sun Y, Jiao R, Liu Z. The Role of Acupuncture in Relieving Post-Hemorrhoidectomy Pain: A Systematic Review of Randomized Controlled Trials. Front Surg. 2022 Mar 28;9:815618. doi: 10.3389/fsurg.2022.815618. eCollection 2022.
PubMed 35419404Hatami M, Talebi M, Heiranizadeh N, Vaziribozorg S. The Effect of Perianal Tramadol Infiltration on Postoperative Pain Following Hemorrhoidectomy. Am Surg. 2022 Jan;88(1):98-102. doi: 10.1177/0003134820981683. Epub 2020 Dec 28.
PubMed 33371715Hopewell S, Chan AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ. 2025 Apr 14;389:e081123. doi: 10.1136/bmj-2024-081123.
PubMed 40228833McCleskey PE, Patel SM, Mansalis KA, Elam AL, Kinsley TR. Serum lidocaine levels and cutaneous side effects after application of 23% lidocaine 7% tetracaine ointment to the face. Dermatol Surg. 2013 Jan;39(1 Pt 1):82-91. doi: 10.1111/dsu.12064. Epub 2012 Dec 26.
PubMed 23278914Linares-Gil MJ, Valls J, Hereu-Boher P, Nebot FJ, De-Ramon B, Diaz-Munio E, Sanzol R, De-Oca J, Perez-Lozano P, Sune-Negre JM, Garcia-Montoya E. Topical Analgesia with Lidocaine Plus Diclofenac Decreases Pain in Benign Anorectal Surgery: Randomized, Double-blind, and Controlled Clinical Trial. Clin Transl Gastroenterol. 2018 Nov 23;9(11):210. doi: 10.1038/s41424-018-0075-7.
PubMed 30467335Khan KI, Waqas A, Akmal M, Mahmood S, Iqbal A. Efficacy of combination of 0.2% GTN and lignocaine ointments in wound healing and pain relief after Milligan Morgan hemorrhoidectomy--a comparison with lignocaine and 0.2% GTN ointments separately. Int J Surg. 2014;12(4):329-33. doi: 10.1016/j.ijsu.2014.01.013. Epub 2014 Jan 29.
PubMed 24486687Shiau JM, Su HP, Chen HS, Hung KC, Lin SE, Tseng CC. Use of a topical anesthetic cream (EMLA) to reduce pain after hemorrhoidectomy. Reg Anesth Pain Med. 2008 Jan-Feb;33(1):30-5. doi: 10.1016/j.rapm.2007.07.012.
PubMed 18155054Rahimi M, Kazemeini AR, Pourtabatabaei N, Honarmand AR. Comparison of topical anesthetic cream (EMLA) and diclofenac suppository for pain relief after hemorrhoidectomy: a randomized clinical trial. Surg Today. 2012 Dec;42(12):1201-5. doi: 10.1007/s00595-012-0222-9. Epub 2012 Jun 19.
PubMed 22711185Xia W, Barazanchi AWH, MacFater WS, MacCormick AD, Svirskis D, Sammour T, Hill AG. Topical Versus Oral Metronidazole After Excisional Hemorrhoidectomy: A Double-Blind Randomized Controlled Trial. Dis Colon Rectum. 2022 Nov 1;65(11):1362-1372. doi: 10.1097/DCR.0000000000002163. Epub 2021 Dec 9.
PubMed 34897211Sugimoto T, Tsunoda A, Kano N, Kashiwagura Y, Hirose K, Sasaki T. A randomized, prospective, double-blind, placebo-controlled trial of the effect of diltiazem gel on pain after hemorrhoidectomy. World J Surg. 2013 Oct;37(10):2454-7. doi: 10.1007/s00268-013-2124-4.
PubMed 23775515Xia W, Park B, Otutaha BF, MacFater WS, MacCormick AD, Sammour T, Hill AG. Topical analgesia following excisional haemorrhoidectomy: a systematic review and meta-analysis of randomised controlled trials. Int J Colorectal Dis. 2020 Feb;35(2):181-197. doi: 10.1007/s00384-019-03497-7. Epub 2020 Jan 2.
PubMed 31897645Sammour T, Barazanchi AW, Hill AG; PROSPECT group (Collaborators). Evidence-Based Management of Pain After Excisional Haemorrhoidectomy Surgery: A PROSPECT Review Update. World J Surg. 2017 Feb;41(2):603-614. doi: 10.1007/s00268-016-3737-1.
PubMed 27766395Lohsiriwat V, Jitmungngan R, Chadbunchachai W, Ungprasert P. Enhanced recovery after surgery in emergency resection for obstructive colorectal cancer: a systematic review and meta-analysis. Int J Colorectal Dis. 2020 Aug;35(8):1453-1461. doi: 10.1007/s00384-020-03652-5. Epub 2020 Jun 22.
PubMed 32572602Van Backer JT, Jordan MR, Leahy DT, Moore JS, Callas P, Dominick T, Cataldo PA. Preemptive Analgesia Decreases Pain Following Anorectal Surgery: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial. Dis Colon Rectum. 2018 Jul;61(7):824-829. doi: 10.1097/DCR.0000000000001069.
PubMed 29771804
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Topical Lidocaine 23%/Tetracaine 7% Ointment Versus Placebo for Post-Hemorrhoidectomy Pain: A Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07688031
- Acronym / sponsor ID
- 220531005
- Conditions
- Pain Management, Hemorrhoids Third Degree, Hemorrhoids Fourth Degree, Hemorrhoids Second Degree
- Keywords
- Hemorrhoidectomy, Postoperative pain, Topical analgesia, Lidocaine, Opioid-sparing, Anorectal surgery, Pain management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Sociedad Chilena de Coloproctología
- Study start
- 24 May 2023 (actual)
- Primary completion
- 9 Oct 2025 (actual)
- Study completion
- 12 May 2026 (actual)
- First posted
- 7 Jul 2026 (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 learn if a topical ointment containing two local anesthetics (lidocaine 23% and tetracaine 7%) can reduce pain after hemorrhoid surgery in adults. The main questions it aims to answer are:
- Does the ointment lower post-defecation pain movements in the first 10 days after surgery?
- Does the ointment lower overall daily pain in the 10 days after surgery?
- Does the ointment reduce the need for rescue pain medication (tramadol)?
Researchers will compare the lidocaine/tetracaine ointment to a placebo (a look-alike ointment that contains no active drug) to see if the active ointment works better to reduce pain after hemorrhoid surgery.
Participants will:
- Apply the ointment or placebo to the anal area every 12 hours for 10 days after surgery
- Rate their pain on a scale from 0 to 10 each day, including pain after bowel movements/defecation
- Record how many times they take rescue pain medication each day
- Receive check-in calls/mesages from the research team after surgery
Detailed description
Background
Hemorrhoidectomy is the most effective surgical treatment for advanced hemorrhoidal disease, but it is associated with significant postoperative pain, particularly during bowel movements. Standard multimodal analgesia regimens, including scheduled non-steroidal anti-inflammatory drugs, acetaminophen, and opioid rescue doses, often provide incomplete relief, especially during defecation. Topical local anesthetics have been explored as adjuvant analgesic agents in this setting, but commercially available formulations use low concentrations (typically 2-2.5%) that may limit their efficacy. High-concentration compounded formulations containing lidocaine 23% and tetracaine 7% have demonstrated an adequate pharmacokinetic safety profile in other clinical settings, but had not been evaluated in proctological surgery prior to this trial.
Study Design
This was a single-center, double-blind, placebo-controlled randomized controlled trial (RCT) conducted at a private academic institution in Santiago, Chile. Participants were randomized in a 1:1 ratio to receive either active ointment (lidocaine 23%/tetracaine 7%) or an identical-appearing placebo ointment. Randomization was performed using a computer-generated sequence with allocation concealment via an encrypted randomization. Both participants and the surgical team were blinded to treatment allocation throughout the follow-up period. The ointments were prepared and labeled by an independent compounding pharmacy, and were identical in color, texture, and packaging.
Intervention
Participants in the intervention group applied approximately 2 g of the lidocaine 23%/tetracaine 7% ointment to the perianal area every 12 hours, beginning on the day of surgery (postoperative day 0) and continuing through postoperative day 10. Participants in the control group applied an identical-appearing placebo ointment following the same schedule. All participants received a standardized perioperative analgesic protocol consisting of scheduled oral ketorolac and acetaminophen, with oral tramadol (25 mg per dose) as rescue analgesia available on demand. Surgical technique was standardized across participating surgeons; trainees operated under direct supervision of board-certified colorectal surgeons.
Outcomes and Measurements
Pain was assessed using a 0-10 visual analogue scale (VAS). Two pain dimensions were recorded daily by participants in a structured paper diary. Post-defecatory pain was recorded as a VAS score immediately after each bowel movement; on days with more than one bowel movement, the mean score was used; on days without a bowel movement, no score was recorded for this dimension. Mean daily pain was recorded as the average VAS score across the entire day, noted each evening. Rescue opioid use was recorded daily as the number of tramadol doses taken. Adverse events were recorded at each follow-up contact and at the end of the 10-day period. Follow-up was conducted by a dedicated research assistant via telephone and messages. Participants were also asked to return their completed diary at the day-10 contact.
Sample Size
Sample size was calculated to detect a clinically relevant 25% reduction in post-defecatory pain, assuming a mean VAS score of 6.6 (SD 2.2), with a two-sided significance level of 0.05 and 80% power, yielding 56 evaluable participants (28 per group). Accounting for an anticipated 10% loss to follow-up, target enrollment was set at 62 patients.
Statistical Analysis
All analyses were performed on an intention-to-treat basis. Continuous variables were compared using the independent samples Student's t-test after confirming normality with the Shapiro-Wilk test and homogeneity of variance with Levene's test. The t-test with equal variances assumed was applied consistently across all time points of each outcome variable to maintain methodological consistency. Categorical variables were compared using Pearson's chi-square test. Period averages for post-defecatory pain (days 1-5 and days 1-10) were calculated as the mean of available daily scores per participant. Daily mean overall pain for the 10-day period was calculated from the pre-specified composite variable. Statistical significance was set at p < 0.05 (two-tailed). All analyses were performed using IBM SPSS Statistics version 29.
Safety Considerations
Prior to trial design, the pharmacokinetic profile of the lidocaine 23%/tetracaine 7% formulation was reviewed. Published data indicate that peak plasma lidocaine concentrations remain below the recognized toxicity threshold of 2 mcg/mL when the formulation is applied to surface areas under 250 cm². In this trial, participants applied approximately 2 g to a perianal surface area of 10-30 cm², representing a substantially lower dose than those associated with systemic toxicity. Participants with conditions associated with increased risk of local anesthetic toxicity (significant cardiovascular, cerebrovascular, or hepatic disease; seizure disorders) were excluded from enrollment. Plasma lidocaine levels were not routinely measured given the low dose used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine/Tetracaine Ointment | Experimental | Drug: Lidocaine 23% / Tetracaine 7% topical ointment (compounded)Participants applied approximately 2 g of compounded lidocaine 23%/tetracaine 7% ointment to the perianal area every 12 hours, beginning on the day of surgery (postoperative day 0) and continuing through postoperative day 10. All participants also received a standardized perioperative analgesic protocol consisting of scheduled oral ketorolac and acetaminophen, with oral tramadol 25 mg per dose available on demand as rescue analgesia. |
| Placebo | Placebo comparator | Other: Placebo ointmentParticipants applied an identical-appearing placebo ointment to the perianal area every 12 hours following the same schedule as the intervention group (postoperative days 0 to 10). The placebo was prepared by the same independent compounding pharmacy and was identical in color, texture, and packaging to the active ointment. All participants also received the same standardized perioperative analgesic protocol consisting of scheduled oral ketorolac and acetaminophen, with oral tramadol 25 mg per dose available on demand as rescue analgesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Scheduled for elective hemorrhoidectomy
- Recruited consecutively on the day of surgery
- Able to provide written informed consent
Key exclusion criteria (10 listed)
- Inflammatory bowel disease
- Immunosuppression
- Pregnancy
- Chronic pain requiring ongoing analgesic treatment
- Known hypersensitivity to any of the study medications
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 |
|---|---|---|
| Lidocaine 23% / Tetracaine 7% topical ointment (compounded)Compounded topical ointment containing lidocaine 23% and tetracaine 7%, prepared by an independent compounding pharmacy. Approximately 2 g applied to the perianal area every 12 hours from postoperative day 0 through day 10. | Drug | Lidocaine/Tetracaine Ointment |
| Placebo ointmentInert topical ointment identical in appearance, color, texture, and packaging to the active intervention, prepared by the same independent compounding pharmacy. Applied following the same schedule as the active ointment | Other | Placebo |
Primary outcome
Post-defecatory pain score during the first 10 postoperative days
Time frame: Postoperative days 1 through 10
Self-reported post-defecatory pain intensity assessed using a 0-10 visual analogue scale (VAS), recorded by participants immediately after each bowel movement. The primary outcome is the mean of available daily post-defecatory VAS scores across postoperative days 1 through 10. On days with more than one bowel movement, the daily score represents the mean of all recordings. Days without a bowel movement are excluded from the calculation.
6 secondary outcomes
Mean daily pain score
Time frame: Postoperative days 1 through 10
Cumulative rescue opioid consumption
Time frame: Postoperative days 1 through 10
Adverse effects related to the study ointment
Time frame: Postoperative days 0 through 10
Postoperative complications within 30 days
Time frame: 30 days postoperatively
Mean post-defecatory pain score during postoperative days 1-5
Time frame: Postoperative days 1 through 5
Mean daily pain score during postoperative days 1-5
Time frame: Postoperative days 1 through 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 39917290Bikfalvi A, Faes C, Freys SM, Joshi GP, Van de Velde M, Albrecht E. PROSPECT guideline for haemorrhoid surgery: A systematic review and procedure-specific postoperative pain management recommendations. Eur J Anaesthesiol Intensive Care. 2023 May 26;2(3):e0023. doi: 10.1097/EA9.0000000000000023. eCollection 2023 Jun.
- Background: PubMed 35419404Chen H, Zhang W, Sun Y, Jiao R, Liu Z. The Role of Acupuncture in Relieving Post-Hemorrhoidectomy Pain: A Systematic Review of Randomized Controlled Trials. Front Surg. 2022 Mar 28;9:815618. doi: 10.3389/fsurg.2022.815618. eCollection 2022.
- Background: PubMed 33371715Hatami M, Talebi M, Heiranizadeh N, Vaziribozorg S. The Effect of Perianal Tramadol Infiltration on Postoperative Pain Following Hemorrhoidectomy. Am Surg. 2022 Jan;88(1):98-102. doi: 10.1177/0003134820981683. Epub 2020 Dec 28.
- Background: PubMed 40228833Hopewell S, Chan AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ. 2025 Apr 14;389:e081123. doi: 10.1136/bmj-2024-081123.
- Background: PubMed 23278914McCleskey PE, Patel SM, Mansalis KA, Elam AL, Kinsley TR. Serum lidocaine levels and cutaneous side effects after application of 23% lidocaine 7% tetracaine ointment to the face. Dermatol Surg. 2013 Jan;39(1 Pt 1):82-91. doi: 10.1111/dsu.12064. Epub 2012 Dec 26.
- Background: PubMed 30467335Linares-Gil MJ, Valls J, Hereu-Boher P, Nebot FJ, De-Ramon B, Diaz-Munio E, Sanzol R, De-Oca J, Perez-Lozano P, Sune-Negre JM, Garcia-Montoya E. Topical Analgesia with Lidocaine Plus Diclofenac Decreases Pain in Benign Anorectal Surgery: Randomized, Double-blind, and Controlled Clinical Trial. Clin Transl Gastroenterol. 2018 Nov 23;9(11):210. doi: 10.1038/s41424-018-0075-7.
- Background: PubMed 24486687Khan KI, Waqas A, Akmal M, Mahmood S, Iqbal A. Efficacy of combination of 0.2% GTN and lignocaine ointments in wound healing and pain relief after Milligan Morgan hemorrhoidectomy--a comparison with lignocaine and 0.2% GTN ointments separately. Int J Surg. 2014;12(4):329-33. doi: 10.1016/j.ijsu.2014.01.013. Epub 2014 Jan 29.
- Background: PubMed 18155054Shiau JM, Su HP, Chen HS, Hung KC, Lin SE, Tseng CC. Use of a topical anesthetic cream (EMLA) to reduce pain after hemorrhoidectomy. Reg Anesth Pain Med. 2008 Jan-Feb;33(1):30-5. doi: 10.1016/j.rapm.2007.07.012.
- Background: PubMed 22711185Rahimi M, Kazemeini AR, Pourtabatabaei N, Honarmand AR. Comparison of topical anesthetic cream (EMLA) and diclofenac suppository for pain relief after hemorrhoidectomy: a randomized clinical trial. Surg Today. 2012 Dec;42(12):1201-5. doi: 10.1007/s00595-012-0222-9. Epub 2012 Jun 19.
- Background: PubMed 34897211Xia W, Barazanchi AWH, MacFater WS, MacCormick AD, Svirskis D, Sammour T, Hill AG. Topical Versus Oral Metronidazole After Excisional Hemorrhoidectomy: A Double-Blind Randomized Controlled Trial. Dis Colon Rectum. 2022 Nov 1;65(11):1362-1372. doi: 10.1097/DCR.0000000000002163. Epub 2021 Dec 9.
- Background: PubMed 23775515Sugimoto T, Tsunoda A, Kano N, Kashiwagura Y, Hirose K, Sasaki T. A randomized, prospective, double-blind, placebo-controlled trial of the effect of diltiazem gel on pain after hemorrhoidectomy. World J Surg. 2013 Oct;37(10):2454-7. doi: 10.1007/s00268-013-2124-4.
- Background: PubMed 31897645Xia W, Park B, Otutaha BF, MacFater WS, MacCormick AD, Sammour T, Hill AG. Topical analgesia following excisional haemorrhoidectomy: a systematic review and meta-analysis of randomised controlled trials. Int J Colorectal Dis. 2020 Feb;35(2):181-197. doi: 10.1007/s00384-019-03497-7. Epub 2020 Jan 2.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The institutional review board and research ethics committee that approved this study (Protocol ID: 220531005) does not authorize the export or transfer of clinical data outside the approved research context. The committee assumes no responsibility for data use beyond the scope of the original protocol and permits access to clinical data only upon formal written request and explicit authorization by the ethics committee.
Related trials for Pain Management
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
RecruitingObservational study
Early Postoperative Pain Following a Limb Amputation
Amputation, Surgical, Pain Management
Not yet recruitingPhase 4
Methadone Versus Standard of Care for Pain Control in Minimally Invasive Lung Resection Surgery
Pain Management
Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
RecruitingPhase 3
Safety and Analgesic Efficacy of the Biased μ-Opioid Receptor Agonist Tegileridine for Post-Operative Analgesia in Patients Undergoing Bariatric Surgery
Pain Management, Overweight , Obesity
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine 23% / Tetracaine 7% topical ointment (compounded) in people with Pain Management and Hemorrhoids Third Degree, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 10 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: finished, as of the sponsor's last update on 7 Jul 2026. 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 Chile. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-defecatory pain score during the first 10 postoperative days (time frame: Postoperative days 1 through 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07688031, which also lists 18 linked publications.
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 7 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.