HemorrhoidNCT07159334
"Lignocaine vs GTN Ointment for Postoperative Pain After Hemorrhoidectomy")
A study testing Lignocaine Ointment and Glyceryl Trinitrate Ointment 0.2% in people with Hemorrhoid and Postoperative Pain, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hemorrhoid, Postoperative Pain
- What is being tested?
- Lignocaine Ointment and Glyceryl Trinitrate Ointment 0.2%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Aug 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
King Edward Medical uUniveristy Mayo Hospital
Lahore, Punjab Province, 54000
Hafiz Ahmad Rauf, Mbbs, +923006023465, ahmadrauf498@gmail.com
Hafiz Ahmad Rauf, Mbbs
About this study
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
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.
Read the 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.
- Conditions
- Hemorrhoid, Postoperative Pain
- Being tested
- Lignocaine Ointment, Glyceryl Trinitrate Ointment 0.2%
- Keywords
- Hemorrhoidectomy, Lignocaine ointment, Glyceryl Trinitrate ointment, Anal pain
- Medical subject headings
- Hemorrhoids, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lignocaine OintmentDrug
Applied to the anal wound three time daily after hemorrhoidectomy.
Glyceryl Trinitrate Ointment 0.2%Drug
Applied to the anal wound three time daily after hemorrhoidectomy.
| Study group | Role | What they receive |
|---|---|---|
| 1.Lignocaine Ointment Group | Experimental | Participants will receive topical lignocaine ointment applied to the anal wound post-hemorrhoidectomy for pain control. Receives: Drug: Lignocaine Ointment; Drug: Glyceryl Trinitrate Ointment 0.2% |
| Glyceryl Trinitrate Ointment Group | Experimental | Participants will receive topical 0.2% glyceryl trinitrate ointment applied to the anal wound post-hemorrhoidectomy for pain control. Receives: Drug: Lignocaine Ointment; Drug: Glyceryl Trinitrate Ointment 0.2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score
Pain intensity will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain severity.
Measured: Up to 1 month postoperatively.
Wound Healing Time
Defined as the number of days from the date of surgery until complete wound healing (full epithelialization with no discharge or open area). Shorter duration indicates a better outcome.
Measured: Up to 1 month postoperatively.
Secondary outcomes (7)
patient Satisfaction Level
Overall satisfaction with postoperative care and treatment, assessed using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). Higher scores indicate greater satisfaction.
Measured: 6 weeks postoperatively
Time to Request of First Analgesic Dose
Time (in minutes/hours) from end of surgery to first request for analgesia. Shorter time indicates earlier need for pain control.
Measured: Within 24 hours postoperatively
Amount of Analgesia Administered in First 24 Hours
Total rescue analgesic dose administered in first 24 hours, recorded in mg (converted to morphine-equivalent dose if applicable). Lower values indicate better pain control.
Measured: 0-24 hours postoperatively
Incidence of Wound Secretion
Presence of wound secretion (yes/no) as noted on clinical examination.
Measured: 1 month postoperatively
Incidence of Itching
Patient-reported pruritus at wound site (yes/no)
Measured: 1 month postoperatively
Incidence of Postoperative Bleeding
Occurrence of wound bleeding postoperatively (yes/no).
Measured: 1 month postoperatively
Incidence and Severity of Headache
Patient-reported headache severity measured using a Numerical Rating Scale (0 = no headache, 10 = worst imaginable).
Measured: 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start2 Aug 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidStudies 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
- "Participants will be randomized into two parallel groups: one receiving topical lignocaine ointment and the other receiving topical glyceryl trinitrate ointment for postoperative pain management after hemorrhoidectomy."
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafiz Ahmad Rauf, Principal investigator, King Edward Medical University/Mayo hospital Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159334
- Sponsor's protocol ID
- Ahmad Rauf
- Status last verified
- Sep 2025
- First submitted
- 21 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07159334
- Acronym / sponsor ID
- Ahmad Rauf
- Conditions
- Hemorrhoid, Postoperative Pain
- Keywords
- Hemorrhoidectomy, Lignocaine ointment, Glyceryl Trinitrate ointment, Anal pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 2 Aug 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Sep 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- "Participants will be randomized into two parallel groups: one receiving topical lignocaine ointment and the other receiving topical glyceryl trinitrate ointment for postoperative pain management after hemorrhoidectomy."
| Arm | Type | Receives |
|---|---|---|
| 1.Lignocaine Ointment Group | Experimental | Drug: Lignocaine Ointment, Drug: Glyceryl Trinitrate Ointment 0.2%Participants will receive topical lignocaine ointment applied to the anal wound post-hemorrhoidectomy for pain control. |
| Glyceryl Trinitrate Ointment Group | Experimental | Drug: Lignocaine Ointment, Drug: Glyceryl Trinitrate Ointment 0.2%Participants will receive topical 0.2% glyceryl trinitrate ointment applied to the anal wound post-hemorrhoidectomy for pain control. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Lignocaine OintmentApplied to the anal wound three time daily after hemorrhoidectomy. | Drug | 1.Lignocaine Ointment Group, Glyceryl Trinitrate Ointment Group |
| Glyceryl Trinitrate Ointment 0.2%Applied to the anal wound three time daily after hemorrhoidectomy. | Drug | 1.Lignocaine Ointment Group, Glyceryl Trinitrate Ointment Group |
Primary outcome
Postoperative pain score
Time frame: Up to 1 month postoperatively.
Pain intensity will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain severity.
Wound Healing Time
Time frame: Up to 1 month postoperatively.
Defined as the number of days from the date of surgery until complete wound healing (full epithelialization with no discharge or open area). Shorter duration indicates a better outcome.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Hafiz Ahmad Rauf principal investigator
King Edward Medical University/Mayo hospital Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lignocaine Ointment and Glyceryl Trinitrate Ointment 0.2% in people with Hemorrhoid and Postoperative Pain, run by King Edward Medical University at 1 site in Pakistan.
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 5 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: looking for participants now, as of the sponsor's last update on 8 Sep 2025. 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 Pakistan. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hafiz Ahmad Rauf, Mbbs,Fcps (+923006023465, ahmadrauf498@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain score (time frame: Up to 1 month postoperatively.). The study lists 2 primary outcomes in all. 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 8 Sep 2025.