PainNCT06256302
Transverses Abdominis Plane Block Versus Local Wound Infiltration in Total Abdominal Hysterectomy
A study testing Transverses Abdominis Plane Block and Local wound infiltration in people with Pain, run by Dr Muhammad Arif at 1 site in Pakistan.
Trial summary
To compare the transverses abdominis plane block outcome versus local wound infiltration for postoperative analgesia in patients undergoing total abdominal hysterectomy. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Pain
- What is being tested?
- Transverses Abdominis Plane Block and Local wound infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 28 Feb 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range 18 to 50 years
- Female
- ASA I \& II
- Undergoing Abdominal Hysterectomy under General anaesthesia
Who cannot join
- Hepatic failure (assessed on clinical signs and symptoms, elevated liver enzymes and ultrasound findings showing loss of normal texture of liver) or renal failure (a GFR of 15 or less)
- Allergy or contraindication to study drugs on history
- Drug abuse or addiction
- Bleeding tendency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transverses Abdominis Plane Block Versus Local Wound Infiltration for Postoperative Pain Management in Patients Undergoing Total Abdominal Hysterectomy
To compare the transverses abdominis plane block outcome versus local wound infiltration for postoperative analgesia in patients undergoing total abdominal hysterectomy.
- Conditions
- Pain
- Being tested
- Transverses Abdominis Plane Block, Local wound infiltration
- Keywords
- Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transverses Abdominis Plane BlockProcedure or surgery
Transverses abdominis plane block will be provided randomly using prospective double-blinding.
Local wound infiltrationProcedure or surgery
Local wound infiltration will be provided randomly using prospective double-blinding.
| Study group | Role | What they receive |
|---|---|---|
| Transverses abdominis plane block | Experimental | Not described Receives: Procedure: Transverses Abdominis Plane Block |
| Local wound infiltration | Active comparator | Not described Receives: Procedure: Local wound infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain score will be evaluated through Visual analogue scale (VAS) score of 0-10cms.
Measured: 24 hours of surgery.
Secondary outcomes (1)
Analgesia consumption
Patients will be given analgesics only on complain of pain of VAS score of 4 and above.
Measured: During 24 hours of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Dec 2023
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Muhammad Arif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Muhammad Arif, Ziauddin University
- Investigators
- Muhammad Arif, Principal investigator, Ziauddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256302
- Sponsor's protocol ID
- 7861023MAANE
- Status last verified
- Jul 2024
- First submitted
- 1 Feb 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transverses Abdominis Plane Block Versus Local Wound Infiltration for Postoperative Pain Management in Patients Undergoing Total Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT06256302
- Acronym / sponsor ID
- 7861023MAANE
- Conditions
- Pain
- Keywords
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dr Muhammad ArifUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 13 Feb 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.
To compare the transverses abdominis plane block outcome versus local wound infiltration for postoperative analgesia in patients undergoing total abdominal hysterectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transverses abdominis plane block | Experimental | Procedure: Transverses Abdominis Plane Block |
| Local wound infiltration | Active comparator | Procedure: Local wound infiltration |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age range 18 to 50 years
- Female
- ASA I \& II
- Undergoing Abdominal Hysterectomy under General anaesthesia
Key exclusion criteria (4 listed)
- Hepatic failure (assessed on clinical signs and symptoms, elevated liver enzymes and ultrasound findings showing loss of normal texture of liver) or renal failure (a GFR of 15 or less)
- Allergy or contraindication to study drugs on history
- Drug abuse or addiction
- Bleeding tendency
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 |
|---|---|---|
| Transverses Abdominis Plane BlockTransverses abdominis plane block will be provided randomly using prospective double-blinding. | Procedure or surgery | Transverses abdominis plane block |
| Local wound infiltrationLocal wound infiltration will be provided randomly using prospective double-blinding. | Procedure or surgery | Local wound infiltration |
Primary outcome
Pain score
Time frame: 24 hours of surgery.
Pain score will be evaluated through Visual analogue scale (VAS) score of 0-10cms.
1 secondary outcome
Analgesia consumption
Time frame: During 24 hours of surgery
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 25 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Muhammad Arif principal investigator
Ziauddin 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 Transverses Abdominis Plane Block and Local wound infiltration in people with Pain, run by Dr Muhammad Arif 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 4 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 25 Jul 2024. 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?
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?
Pain score (time frame: 24 hours of surgery.). 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 25 Jul 2024.