Идёт набор NCT07159334

"Lignocaine vs GTN Ointment for Postoperative Pain After Hemorrhoidectomy")

Без фазы С лечением Hemorrhoid Postoperative Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Lignocaine Ointment, Glyceryl Trinitrate Ointment 0.2%.
Кому может быть актуально: Состояния в реестре: Hemorrhoid, Postoperative Pain. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Пакистан
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Role of Topical Application of Lignocaine Versus 0.2% Glyceryl Trinitrate (GTN) Ointment as a Postoperative Local Analgesic in Hemorrhoidectomy in Terms of Pain Score,Wound Healing Time and Patient Satisfaction Level

Обзор

This study is being conducted at the Department of General Surgery, King Edward Medical University, Lahore, Pakistan. The purpose of the trial is to compare the effectiveness of topical Lignocaine ointment versus topical Glyceryl Trinitrate (GTN) ointment in reducing postoperative pain following hemorrhoidectomy. Patients undergoing hemorrhoidectomy will be randomly assigned to receive either Lignocaine ointment or GTN ointment applied locally after surgery. Pain relief will be assessed using a visual analog scale (VAS) at regular intervals during the postoperative period. The study aims to determine which ointment provides better pain control and improves patient comfort during recovery.

Подробное описание

This study aims to compare the effectiveness of lignocaine versus 0.2% glyceryl trinitrate (GTN) ointment as postoperative analgesics in patients who have undergone hemorrhoidectomy.

Background

Hemorrhoids are swollen veins in the anal region, commonly treated through Milligan-Morgan hemorrhoidectomy. Postoperative pain is a major concern, affecting mobility and delaying recovery.

Various treatments have been explored to alleviate post-hemorrhoidectomy pain, including anal dilatation, NSAIDs, opioids, and topical treatments like nifedipine, botulinum toxin, lignocaine, and GTN ointment.

Both GTN and lignocaine have been shown to reduce pain, but the most effective and safe option is still unclear.

Study Objective

To compare the outcomes of lignocaine versus 0.2% GTN ointment in reducing pain and promoting wound healing in post-hemorrhoidectomy patients.

Hypothesis

There is a difference in the pain relief and wound healing outcomes between lignocaine and GTN ointment in hemorrhoidectomy patients.

Study Design

Randomized clinical trial conducted at the Department of Surgery, Mayo Hospital, Lahore.

Duration: 3-6 months after synopsis approval.

Sample Size: 64 patients (32 in each group).

Inclusion Criteria: Age 18-60, both genders, Grade III/IV hemorrhoids, ASA grades I \& II.

Exclusion Criteria: Allergies to lignocaine or GTN, pregnancy, concomitant perianal pathology, cardiovascular issues, use of nitrates or calcium channel blockers.

Methods

Participants will undergo hemorrhoidectomy under spinal anesthesia/saddle block/general anesthesia.

Group A will receive lignocaine cream, and Group B will receive 0.2% GTN ointment post-operatively (applied 3 times daily).

Both groups will receive standard postoperative care (sitz baths, stool softeners, and paracetamol for pain).

Outcome Measures:

Pain Score using Visual Analogue Scale (VAS) at various time points (6, 12, 24, 48, 72 hours; 7, 14, 21, and 28 days post-surgery).

Time to complete wound healing (measured in days).

Level of patient satisfaction after 6 weeks using a 5-point Likert scale.

Data Analysis

Data will be analyzed using SPSS. Descriptive statistics for quantitative variables (e.g., age, pain scores) and qualitative variables (e.g., gender, patient satisfaction).

Independent t-tests will be used to compare outcomes between groups. A p-value \< 0.05 will be considered statistically significant.

Patient Follow-Up

Patients will be followed for 6 weeks post-surgery to monitor pain levels, wound healing, and satisfaction.

Conclusion

This trial aims to determine which topical analgesic-lignocaine or GTN ointment-is more effective for postoperative pain management and wound healing in hemorrhoidectomy patients.

Вмешательства

Препарат Lignocaine Ointment
Applied to the anal wound three time daily after hemorrhoidectomy.
Препарат Glyceryl Trinitrate Ointment 0.2%
Applied to the anal wound three time daily after hemorrhoidectomy.

Первичные конечные точки

Postoperative pain score [Срок оценки: Up to 1 month postoperatively.]
Wound Healing Time [Срок оценки: Up to 1 month postoperatively.]

Вторичные конечные точки (7)

patient Satisfaction Level [Срок оценки: 6 weeks postoperatively]
Time to Request of First Analgesic Dose [Срок оценки: Within 24 hours postoperatively]
Amount of Analgesia Administered in First 24 Hours [Срок оценки: 0-24 hours postoperatively]
Incidence of Wound Secretion [Срок оценки: 1 month postoperatively]
Incidence of Itching [Срок оценки: 1 month postoperatively]
Incidence of Postoperative Bleeding [Срок оценки: 1 month postoperatively]
Incidence and Severity of Headache [Срок оценки: 1 month postoperatively]

Критерии участия

Критерии включения

Age between 18 - 60 years
Both genders
Grade III and IV hemorrhoids diagnosed on the basis of history and clinical examination by consultant Surgeon.(Grade III Hemorrhoid manually reduced by patient with finger and Grade IV is prolapsed)
ASA (American society of Anesthesia) grades I, and II