Midline LaparotomyNCT07254130
COMPARISON OF MEAN DURATION OF POST OPERATIVE ANALGESIA FOLLOWING ADDITION OF DEXMEDETOMIDINE TO ROPIVACAINE VERSUS PLAIN ROPIVACAINE ON ULTRASOUND GUIDED RECTUS SHEATH BLOCK
A study testing Rectus Sheath Block in people with Midline Laparotomy, run by Quaid-e-Azam Medical College at 1 site in Pakistan.
Trial summary
To compare the mean duration of postoperative analgesia following addition of dexmedetomidine to ropivacaine versus plain ropivacaine in ultrasound guided rectus sheath block in patients undergoing midline laparotomies Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Midline Laparotomy
- What is being tested?
- Rectus Sheath Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Feb 2025to 20 Sep 2025
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with age 30 - 60 years.
- Patients that will be scheduled for laparotomy under general anesthesia.
- ASA (American Society of Anesthesiologist) s
Who cannot join
- Patient who will refuse for participation in study.
- Infection at site of Rectus Sheath block.
- History of any addiction.
- Sensitivity to the local anesthetics.
- Patient with pre-existing coagulation abnormalities INR more than 1.5.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Bahawal Victoria Hospital, Bahawalpur
Bahawalpur, Punjab Province, 63100
About this study
Official title: COMPARISON OF MEAN DURATION OF POST OPERATIVE ANALGESIA FOLLOWING ADDITION OF DEXMEDETOMIDINE TO ROPIVACAINE VERSUS PLAIN ROPIVACAINE ON ULTRASOUND GUIDED RECTUS SHEATH BLOCK IN PATIENTS UNDERGOING MIDLINE LAPAROTOMIES
To compare the mean duration of postoperative analgesia following addition of dexmedetomidine to ropivacaine versus plain ropivacaine in ultrasound guided rectus sheath block in patients undergoing midline laparotomies
- Conditions
- Midline Laparotomy
- Being tested
- Rectus Sheath Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectus Sheath BlockProcedure or surgery
In Dexmedetomedine combined with ropivacaine group, under ultrasound guidance, the needle will be advanced posterior to the rectus muscle, and 20 ml of 0.25% ropivacaine mixed with 1ug/kg body weight will be injected to hydrodissect the rectus muscle from the posterior sheath.
In ropivacine only group, under ultrasound guidance, the needle will be advanced posterior to the rectus muscle, and 20 ml of 0.25% ropivacaine will be injected to hydrodissect the rectus muscle from the posterior sheath.
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine only group | Active comparator | Not described Receives: Procedure: Rectus Sheath Block |
| Dexmedetomedine combined with ropivacaine group | Active comparator | Not described Receives: Procedure: Rectus Sheath Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean duration of analgesia
Assessed using the visual analogue score(VAS) ranging from 0-10 (0=no pain , 10= most severe unbearable pain)
Measured: Baseline , 30 minutes , 2 hours, 4 hours , 6 hours , 8 hours , 12 hours , 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start28 Feb 2025
- Primary completion28 Aug 2025
- Study completion20 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Midline LaparotomyStudies 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
- Masking
- None (open label)
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quaid-e-Azam Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anam Mahmood, Quaid-e-Azam Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254130
- Sponsor's protocol ID
- BVH-2025-CT-012
- Status last verified
- Oct 2025
- First submitted
- 19 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF MEAN DURATION OF POST OPERATIVE ANALGESIA FOLLOWING ADDITION OF DEXMEDETOMIDINE TO ROPIVACAINE VERSUS PLAIN ROPIVACAINE ON ULTRASOUND GUIDED RECTUS SHEATH BLOCK IN PATIENTS UNDERGOING MIDLINE LAPAROTOMIES
- ClinicalTrials.gov ID
- NCT07254130
- Acronym / sponsor ID
- BVH-2025-CT-012
- Conditions
- Midline Laparotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Quaid-e-Azam Medical CollegeUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 20 Sep 2025 (actual)
- First posted
- 28 Nov 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.
To compare the mean duration of postoperative analgesia following addition of dexmedetomidine to ropivacaine versus plain ropivacaine in ultrasound guided rectus sheath block in patients undergoing midline laparotomies
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine only group | Active comparator | Procedure: Rectus Sheath Block |
| Dexmedetomedine combined with ropivacaine group | Active comparator | Procedure: Rectus Sheath Block |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with age 30 - 60 years.
- Patients that will be scheduled for laparotomy under general anesthesia.
- ASA (American Society of Anesthesiologist) s
Key exclusion criteria (5 listed)
- Patient who will refuse for participation in study.
- Infection at site of Rectus Sheath block.
- History of any addiction.
- Sensitivity to the local anesthetics.
- Patient with pre-existing coagulation abnormalities INR more than 1.5.
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 |
|---|---|---|
| Rectus Sheath BlockIn Dexmedetomedine combined with ropivacaine group, under ultrasound guidance, the needle will be advanced posterior to the rectus muscle, and 20 ml of 0.25% ropivacaine mixed with 1ug/kg body weight will be injected to hydrodissect the rectus muscle from the posterior sheath. In ropivacine only group, under ultrasound guidance, the needle will be advanced posterior to the rectus muscle, and 20 ml of 0.25% ropivacaine will be injected to hydrodissect the rectus muscle from the posterior sheath. | Procedure or surgery | Dexmedetomedine combined with ropivacaine group, Ropivacaine only group |
Primary outcome
Mean duration of analgesia
Time frame: Baseline , 30 minutes , 2 hours, 4 hours , 6 hours , 8 hours , 12 hours , 24 hours
Assessed using the visual analogue score(VAS) ranging from 0-10 (0=no pain , 10= most severe unbearable pain)
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 28 Nov 2025.
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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 study testing Rectus Sheath Block in people with Midline Laparotomy, run by Quaid-e-Azam Medical College 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 3 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: finished, as of the sponsor's last update on 28 Nov 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?
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?
Mean duration of analgesia (time frame: Baseline , 30 minutes , 2 hours, 4 hours , 6 hours , 8 hours , 12 hours , 24 hours). 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 28 Nov 2025.