Acute Post Operative PainNCT06307106
Various Strategies to Reduce Acute Post Hemorrhoidectomy Pain: A Comparative Study
A study testing ketorolac and light marcaine, light marcaine and Corticosteroids injection in people with Acute Post Operative Pain, run by Zagazig University at 1 site in Egypt.
Trial summary
Since post hemorrhoidectomy pain is a severe and common post operative symptom so there is a need to find a suitable method for reducing this pain, up to our knowledge, this the first study in ZUH to compare between ketrolac, light Marcaine, corticosteroids and diclofenac sodium injection at surgical site for relieve… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Post Operative Pain
- What is being tested?
- ketorolac and light marcaine, light marcaine and Corticosteroids injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jan 2024to 14 Oct 2024
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- both sex.
- age from 18 to 60.
Who cannot join
- patient refusal.
- patients with associated ano-rectal diseases such as fissures, fistulas, ano-proctitis, recurrent or thrombosed hemorrhoids and ano-rectal malignancy.
- patients with liver cell failure. patients unfit for surgery according to American Society of Anesthesiologists.
Trial locations and contacts
1 site in 1 country.
About this study
Since post hemorrhoidectomy pain is a severe and common post operative symptom so there is a need to find a suitable method for reducing this pain, up to our knowledge, this the first study in ZUH to compare between ketrolac, light Marcaine, corticosteroids and diclofenac sodium injection at surgical site for relieve of post operative pain. This is a randomized controlled comparative prospective clinical trial.
- Conditions
- Acute Post Operative Pain
- Being tested
- ketorolac and light marcaine, light marcaine, Corticosteroids injection, Diclofenac Sodium Gel, the standard analgesic protocol
- Keywords
- hemorrhoidectomy, acute pain, corticosteroids
- Medical subject headings
- Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketorolac and light marcaineDrug
local injection at surgical site of 30 mg ketorolac and 7-1.5 mg\kg\dose light marcaine
light marcaineDrug
local injection at surgical site of 7-1.5 mg\kg\dose light marcaine
Corticosteroids injectionDrug
local injection at surgical site of 40 mg\ dose of dexamethasone
Diclofenac Sodium GelDrug
topical application of Diclofenac Sodium Gel
the standard analgesic protocolOther
the routine analgesia was given without local analgesia application
| Study group | Role | What they receive |
|---|---|---|
| group A: ketorolac and light marcaine injection | Experimental | Not described Receives: Drug: ketorolac and light marcaine |
| group B: light marcaine injection | Experimental | Not described Receives: Drug: light marcaine |
| group C: corticosteroids injection | Experimental | Not described Receives: Drug: Corticosteroids injection |
| group D: topical diclofenac sodium | Experimental | Not described Receives: Drug: Diclofenac Sodium Gel |
| control group | Sham comparator | control group was given the ordinary analgesic protocol without local analgesic application Receives: Other: the standard analgesic protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
age
adults from 18 to 60 years old
Measured: within 2 days before operation
sex
both sex were included
Measured: within 2 days before operation
number of hemorrhoids
number of hemorrhoids clinically assessed
Measured: within 2 days before operation and intra-operatively
degree of hemorroids
degree of hemorroids clinically assessed
Measured: within 2 days before operation and intra-operatively
post operative pain
post operative assessed using visual analogue scale, minimum score is zero means painless and maximum score 10 means very painful
Measured: 1st, 2nd 3rd, 7th, 14th days post-operatively
ambulation
early ambulation is evaluated in patients post-operatively
Measured: from 1st to 3rd day post-operatively
return to work
first time to return to work is evaluated
Measured: from one day to one month post-operatively
patient satisfaction
patient satisfaction about post-operative pain is assessed using customer satisfaction score. Minimum score is 0 and means very unsatisfied, maximum score is 10 and means very satisfied
Measured: from one day to one month post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start14 Jan 2024
- Primary completion14 Oct 2024
- Study completion14 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Post Operative PainStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Reham Zakaria Mohamed Ahmed, Zagazig University
- Investigators
- Reham Zakaria, PhD, Study chair, faculty of medicine Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307106
- Sponsor's protocol ID
- #40\14-Jan-2024
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After completion the study, interested researchers can contact us for providing any data
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Various Strategies to Reduce Acute Post Hemorrhoidectomy Pain: A Comparative Study
- ClinicalTrials.gov ID
- NCT06307106
- Acronym / sponsor ID
- #40\14-Jan-2024
- Conditions
- Acute Post Operative Pain
- Keywords
- hemorrhoidectomy, acute pain, corticosteroids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 14 Jan 2024 (actual)
- Primary completion
- 14 Oct 2024 (actual)
- Study completion
- 14 Oct 2024 (actual)
- First posted
- 12 Mar 2024 (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.
Since post hemorrhoidectomy pain is a severe and common post operative symptom so there is a need to find a suitable method for reducing this pain, up to our knowledge, this the first study in ZUH to compare between ketrolac, light Marcaine, corticosteroids and diclofenac sodium injection at surgical site for relieve of post operative pain. This is a randomized controlled comparative prospective clinical trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| group A: ketorolac and light marcaine injection | Experimental | Drug: ketorolac and light marcaine |
| group B: light marcaine injection | Experimental | Drug: light marcaine |
| group C: corticosteroids injection | Experimental | Drug: Corticosteroids injection |
| group D: topical diclofenac sodium | Experimental | Drug: Diclofenac Sodium Gel |
| control group | Sham comparator | Other: the standard analgesic protocolcontrol group was given the ordinary analgesic protocol without local analgesic application |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- both sex.
- age from 18 to 60.
Key exclusion criteria (3 listed)
- patient refusal.
- patients with associated ano-rectal diseases such as fissures, fistulas, ano-proctitis, recurrent or thrombosed hemorrhoids and ano-rectal malignancy.
- patients with liver cell failure. patients unfit for surgery according to American Society of Anesthesiologists.
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 |
|---|---|---|
| ketorolac and light marcainelocal injection at surgical site of 30 mg ketorolac and 7-1.5 mg\kg\dose light marcaine | Drug | group A: ketorolac and light marcaine injection |
| light marcainelocal injection at surgical site of 7-1.5 mg\kg\dose light marcaine | Drug | group B: light marcaine injection |
| Corticosteroids injectionlocal injection at surgical site of 40 mg\ dose of dexamethasone | Drug | group C: corticosteroids injection |
| Diclofenac Sodium Geltopical application of Diclofenac Sodium Gel | Drug | group D: topical diclofenac sodium |
| the standard analgesic protocolthe routine analgesia was given without local analgesia application | Other | control group |
Primary outcome
age
Time frame: within 2 days before operation
adults from 18 to 60 years old
sex
Time frame: within 2 days before operation
both sex were included
number of hemorrhoids
Time frame: within 2 days before operation and intra-operatively
number of hemorrhoids clinically assessed
degree of hemorroids
Time frame: within 2 days before operation and intra-operatively
degree of hemorroids clinically assessed
post operative pain
Time frame: 1st, 2nd 3rd, 7th, 14th days post-operatively
post operative assessed using visual analogue scale, minimum score is zero means painless and maximum score 10 means very painful
ambulation
Time frame: from 1st to 3rd day post-operatively
early ambulation is evaluated in patients post-operatively
return to work
Time frame: from one day to one month post-operatively
first time to return to work is evaluated
patient satisfaction
Time frame: from one day to one month post-operatively
patient satisfaction about post-operative pain is assessed using customer satisfaction score. Minimum score is 0 and means very unsatisfied, maximum score is 10 and means very satisfied
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 8 Apr 2025.
- Individual participant dataSharing planned: No. After completion the study, interested researchers can contact us for providing any data
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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. This study is not recruiting at the moment.
Reham Zakaria, PhD study chair
faculty of medicine Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ketorolac and light marcaine, light marcaine and Corticosteroids injection in people with Acute Post Operative Pain, run by Zagazig University at 1 site in Egypt.
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 2 inclusion and 3 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 8 Apr 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 Egypt. 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.
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?
age (time frame: within 2 days before operation). The study lists 8 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 Apr 2025.