## Protocol Section
### Identification Module
**NCT ID:** NCT06420388

**Brief Title:** 2% Lidocaine Gel in Reducing Postoperative Pain Following Haemorrhoidectomy

**Official Title:** Efficacy of 2% Lidocaine Gel in Reducing Postoperative Pain and Analgesic Consumption Following Haemorrhoidectomy: A Randomized, Double-Blind, Controlled Trial

#### Organization Study ID Info
**ID:** EMRP28112N
#### Organization
**Class:** OTHER
**Full Name:** E-DA Hospital
### Status Module
#### Completion Date
**Date:** 2024-10-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-05-01

**Type:** ACTUAL

**Status Verified Date:** 2023-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** E-DA Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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. 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.

Endpoints:

Primary: Postoperative pain measured using a VAS at 12 and 24 hours and 2, 3, and 7 days after surgery Secondary: Analgesic consumption and postoperative complications

Intervention:

Intervention group: 5 mL 2% lidocaine gel three times per day postoperatively Control group: 5 mL non-anaesthetic water-based lubricant gel

Key eligibility criteria:

Inclusion: Age ≥18 years, Grade III-IV haemorrhoids, candidate for Ferguson haemorrhoidectomy Exclusion: Not a candidate for Ferguson haemorrhoidectomy, recurrent hemorrhoidal disease, concurrent anal pathology, history of diabetes/liver disease/IBD/neuropathy/coagulopathy, on anticoagulants, allergy to study drugs

Planned statistical analyses:

Descriptive statistics will be used for qualitative and quantitative variables. Chi-square test, Student's t-test, and ANOVA will be used depending on the nature of the data. A p-value \<0.05 will be considered statistically significant.

### Conditions Module

**Conditions:**

- Surgery

- Pain, Postoperative

**Keywords:**

- hemorrhoids

- pain management

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention 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 Info

**Masking:** QUADRUPLE

**Masking Description:** This study employed a double-blind masking approach to minimize potential bias. Patients, surgeons, and outcome assessors were blinded to treatment allocation. The randomization scheme was generated by a third party not involved in patient care, and sealed envelopes containing the allocation were opened only after the haemorrhoidectomy procedure was completed. The study gels were packaged identically to maintain blinding. Unblinding occurred only after data analysis was completed. This double-blind design ensured that knowledge of treatment allocation did not influence postoperative care, patient-reported pain scores, or the assessment of outcomes.

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 400

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Drug: 2% Lidocaine Gel

- Drug: Standard Postoperative Analgesics

**Label:** Lidocaine Gel

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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

**Intervention Names:**

- Drug: Water-based Lubricant Gel (K-Y Gel)

- Drug: Standard Postoperative Analgesics

**Label:** Controlled

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Lidocaine Gel

**Description:** 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.

**Name:** 2% Lidocaine Gel

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Controlled

**Description:** 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.

**Name:** Water-based Lubricant Gel (K-Y Gel)

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Controlled

- Lidocaine Gel

**Description:** 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 COX-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

**Name:** Standard Postoperative Analgesics

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Postoperative pain

**Time Frame:** Assessed at 12 hours, 24 hours, 2 days, 3 days, and 7 days after surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age 18 years or older
* Diagnosed with Grade III or IV hemorrhoids
* Candidate for Ferguson haemorrhoidectomy

Exclusion Criteria:

* Not a candidate for Ferguson haemorrhoidectomy
* Recurrent hemorrhoidal disease
* Concurrent anal pathology diagnosed preoperatively, including:
* Anal fistula
* Anal fissure
* Anal polyp
* 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

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ed111988@edah.org.tw

**Name:** Chen Chih-i

**Phone:** +886978060015

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Kaohsiung

**Contacts:**

***Contact 1:***

- **Email:** ed111988@edah.org.tw

- **Name:** Chen Chih-I

- **Phone:** +886978060015

- **Role:** CONTACT

**Country:** Taiwan

**Facility:** E-Da hospital

**Status:** RECRUITING

**Zip:** 812

#### Overall Officials

**Official 1:**

**Affiliation:** E-DA Hospital

**Name:** Chen Chih-I

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** 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.

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

**Time Frame:** 1 year

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M13069

- Name: Pain, Postoperative

- Relevance: HIGH

- As Found: Pain, Postoperative

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M9570

- Name: Hemorrhoids

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010149

- Term: Pain, Postoperative

### Intervention Browse Module - Ancestors

- ID: D000000779

- Term: Anesthetics, Local

- ID: D000000777

- Term: Anesthetics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000000889

- Term: Anti-Arrhythmia Agents

- ID: D000061567

- Term: Voltage-Gated Sodium Channel Blockers

- ID: D000026941

- Term: Sodium Channel Blockers

- ID: D000049990

- Term: Membrane Transport Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: Antipy

- Name: Antipyretics

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: ChanBlk

- Name: Channel Blockers

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

### Intervention Browse Module - Browse Leaves

- ID: M2340

- Name: Acetaminophen

- Relevance: LOW

- As Found: Unknown

- ID: M11014

- Name: Lidocaine

- Relevance: HIGH

- As Found: Solution

- ID: M4032

- Name: Analgesics

- Relevance: HIGH

- As Found: Auditory

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M277

- Name: Celecoxib

- Relevance: LOW

- As Found: Unknown

- ID: M4218

- Name: Anti-Inflammatory Agents, Non-Steroidal

- Relevance: LOW

- As Found: Unknown

- ID: M227681

- Name: Parecoxib

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

- ID: M4213

- Name: Anti-Arrhythmia Agents

- Relevance: LOW

- As Found: Unknown

- ID: M23177

- Name: Sodium Channel Blockers

- Relevance: LOW

- As Found: Unknown

- ID: M30025

- Name: Diuretics, Potassium Sparing

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008012

- Term: Lidocaine

- ID: D000000700

- Term: Analgesics

### Misc Info Module

- Version Holder: 2024-05-31
