AnesthesiaPhase 4NCT03394001
Wound Infiltration With Ketorolac Versus Lidocaine for Postoperative Analgesia After Total Abdominal Hysterectomy
A Phase 4 study testing Wound infiltration, Lidocaine Hydrochloride and Ketorolac tromethamine in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The main goal of this study is to compare wound infiltration with ketorolac versus lidocaine for postoperative analgesia in total abdominal hystrectomy (TAH) operation. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Anesthesia
- What is being tested?
- Wound infiltration, Lidocaine Hydrochloride and Ketorolac tromethamine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to Jun 2018
- Phase
- Phase 4
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I and II
- Planned for elective TAH with a Pfannenstiel incision
Who cannot join
- Patients with the following criteria will be excluded from the study;
- ASA physical status more than II
- Body mass index (BMI)>35 kg/m2
- Previous abdominal surgeries
- Malignancy
- Individuals with chronic pain
Show all 10Show fewer
- A history of severe systemic disease
- A pre-existing neurological or psychiatric illness
- Known to be addict on alcohol or drugs
- Known allergy to the study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wound Infiltration With Ketorolac Versus Lidocaine for Postoperative Analgesia After Total Abdominal Hysterectomy: a Prospective, Randomized, Double-blind Study.
The main goal of this study is to compare wound infiltration with ketorolac versus lidocaine for postoperative analgesia in total abdominal hystrectomy (TAH) operation.
- Conditions
- Anesthesia
- Being tested
- Wound infiltration, Lidocaine Hydrochloride, Ketorolac tromethamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound infiltrationProcedure or surgery
Before skin closure,the subcutaneous tissue and skin all around the wound will be infiltrated by 20 mL of the drug then closure of the skin will be done.
Lidocaine HydrochlorideDrug
Also called Lidocaine Hydrochloride; Lidocaine HCL 50mg/5 ml
20 ml of 1% Lidocaine solution
Ketorolac tromethamineDrug
Also called Adolor; Ketorolac tromethamine 30mg/2ml
20 mL of saline with 30 mg ketorolac
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Hydrochloride | Active comparator | Wound infiltration with Lidocaine Receives: Procedure: Wound infiltration; Drug: Lidocaine Hydrochloride |
| Ketorolac tromethamine | Active comparator | Wound infiltration with Ketorolac Receives: Procedure: Wound infiltration; Drug: Ketorolac tromethamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rescue analgesia time
Time for first analgesia requirement
Measured: First 24 hours postoperatively
Secondary outcomes (2)
Patient's pain score
Pain score will be done by visual analog scale (VAS) (minimum 0 = no pain, while maximum 10 cm = worst possible pain). Pain score will be recorded just after extubation (taken as 0 h) and after 1, 2, 4, 6, 12, 18 and 24 h later. Patients will be instructed about the usage of VAS scalebefore the operation.
Measured: First 24 hours postoperatively
The total analgesic consumption
Postoperative analgesia will be provided with intramuscular (IM) meperidine 50 mg to both groups when the VAS score is ≥4. The total meperidine consumption will be recorded.
Measured: First 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start1 Jan 2018
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mostafa Mohamed Ali Mowafi, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394001
- Sponsor's protocol ID
- FMASU R47/2017
- Status last verified
- Jan 2018
- First submitted
- 3 Jan 2018
- Last updated
- 9 Jan 2018
- Results posted
- No
- 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 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Infiltration With Ketorolac Versus Lidocaine for Postoperative Analgesia After Total Abdominal Hysterectomy: a Prospective, Randomized, Double-blind Study.
- ClinicalTrials.gov ID
- NCT03394001
- Acronym / sponsor ID
- FMASU R47/2017
- Conditions
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 9 Jan 2018 (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.
The main goal of this study is to compare wound infiltration with ketorolac versus lidocaine for postoperative analgesia in total abdominal hystrectomy (TAH) operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Hydrochloride | Active comparator | Procedure: Wound infiltration, Drug: Lidocaine HydrochlorideWound infiltration with Lidocaine |
| Ketorolac tromethamine | Active comparator | Procedure: Wound infiltration, Drug: Ketorolac tromethamineWound infiltration with Ketorolac |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA physical status I and II
- Planned for elective TAH with a Pfannenstiel incision
Key exclusion criteria (10 listed)
- Patients with the following criteria will be excluded from the study;
- ASA physical status more than II
- Body mass index (BMI)>35 kg/m2
- Previous abdominal surgeries
- Malignancy
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 |
|---|---|---|
| Wound infiltrationBefore skin closure,the subcutaneous tissue and skin all around the wound will be infiltrated by 20 mL of the drug then closure of the skin will be done. | Procedure or surgery | Ketorolac tromethamine, Lidocaine Hydrochloride |
| Lidocaine HydrochlorideAlso: Lidocaine Hydrochloride; Lidocaine HCL 50mg/5 ml20 ml of 1% Lidocaine solution | Drug | Lidocaine Hydrochloride |
| Ketorolac tromethamineAlso: Adolor; Ketorolac tromethamine 30mg/2ml20 mL of saline with 30 mg ketorolac | Drug | Ketorolac tromethamine |
Primary outcome
Rescue analgesia time
Time frame: First 24 hours postoperatively
Time for first analgesia requirement
2 secondary outcomes
Patient's pain score
Time frame: First 24 hours postoperatively
The total analgesic consumption
Time frame: First 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Wound infiltration, Lidocaine Hydrochloride and Ketorolac tromethamine in people with Anesthesia, run by Ain Shams 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 10 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: status not confirmed, as of the sponsor's last update on 9 Jan 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Rescue analgesia time (time frame: First 24 hours postoperatively). 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 9 Jan 2018.