"Lignocaine vs GTN Ointment for Postoperative Pain After Hemorrhoidectomy")
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lignocaine Ointment, Glyceryl Trinitrate Ointment 0.2%.
- Who it may be relevant to
- Registry conditions: Hemorrhoid, Postoperative Pain. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Drug Lignocaine Ointment
Applied to the anal wound three time daily after hemorrhoidectomy. - Drug Glyceryl Trinitrate Ointment 0.2%
Applied to the anal wound three time daily after hemorrhoidectomy.
Primary outcome measures
- Postoperative pain score [Time frame: Up to 1 month postoperatively.]
- Wound Healing Time [Time frame: Up to 1 month postoperatively.]
Secondary outcome measures (7)
- patient Satisfaction Level [Time frame: 6 weeks postoperatively]
- Time to Request of First Analgesic Dose [Time frame: Within 24 hours postoperatively]
- Amount of Analgesia Administered in First 24 Hours [Time frame: 0-24 hours postoperatively]
- Incidence of Wound Secretion [Time frame: 1 month postoperatively]
- Incidence of Itching [Time frame: 1 month postoperatively]
- Incidence of Postoperative Bleeding [Time frame: 1 month postoperatively]
- Incidence and Severity of Headache [Time frame: 1 month postoperatively]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Previously reported allergy or reaction to lignocaine and GTN
- Pregnancy or lactation
- Concomitant perianal pathology warranting surgery
- Cardiovascular disease
- Patient taking Nitrates or Calcium channel blocker
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- King Edward Medical uUniveristy Mayo Hospital — Lahore
Identifiers
NCT: NCT07159334 · Ahmad Rauf