Post Operative AnalgesiaPhase 4NCT07508202
Comparison of Post Operative Analgesia in Patients Undergoing Lower Abdominal Surgeries Receiving Ultrasound Guided Block With Dexmetomidine vs Dexmethasone
A Phase 4 study testing Dexmedetomidine and Dexamethasone in people with Post Operative Analgesia and Dexmedetomidine, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
Lower abdominal surgeries cause significant pain and can be managed by injecting local anesthetic agents between muscles of abdominal wall that can provide post operative pain relief and its duration can be prolonged by adding drugs to local anesthetic regimen Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Analgesia, Dexmedetomidine, TAP Block
- What is being tested?
- Dexmedetomidine and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Mar 2026to 26 Jun 2026
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I and ASA II BMI 25-35 kg/m2 Lower abdominal surgeries below L2-L3 leves
Who cannot join
- Infection at block site Coagulopathy Antiplatelet
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Institute of Medical Sciences Islamabad
Islamabad, Federal, 44000
About this study
Official title: Comparison of Mean Duration of Post Operative Analgesia in Patients Undergoing Lower Abdominal Surgeries Receiving US Transversus Abdominis Plane Block (TAP) With Bupivacaine and Dexmetomidine vs Bupivacaine nd Dexmethasone
Lower abdominal surgeries cause significant pain and can be managed by injecting local anesthetic agents between muscles of abdominal wall that can provide post operative pain relief and its duration can be prolonged by adding drugs to local anesthetic regimen
Read the detailed description
TAPP block can provide significant post operative analgesia following lower abdominal surgery and its duration can be prolonged by adding adjuvants to local anesthetics.
- Conditions
- Post Operative Analgesia, Dexmedetomidine, TAP Block
- Being tested
- Dexmedetomidine, Dexamethasone
- Keywords
- Post opertive analgesia in lower abdominal surgeries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
20 ml 0.25% Bupivacaine along with 0.5 Mcg/kg of Dexmedetomidine will be given in TAPP block bilaterally
DexamethasoneDrug
20 ml 0.25% Bupivacaine along with 4 mg of Dexamethasone will be given in TAPP block bilaterally
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | Not described Receives: Drug: Dexmedetomidine |
| Dexamethasone | Active comparator | Not described Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resuce analgesia
Measured: Time in the post operative period when patient first demands rescues analgesia will be noted in minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start27 Mar 2026
- Primary completion26 Jun 2026
- Study completion26 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative AnalgesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Department of Anesthesia, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508202
- Sponsor's protocol ID
- F52/2024(ERRC)/PIMS
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Hospital Ethical Committe doesnt allow
Publications
Sobhy YS, Gadalla RR, Nofal WH, Saleh MAE, Abdou KM. A comparative study between the use of dexmedetomidine .vs dexamethasone as adjuvants to bupivacaine in ultrasound-guided transversus abdominis plane block for postoperative pain relief in patients undergoing lower abdominal surgeries. Anaesth. pain intensive care 2022;26(5):681-688
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mean Duration of Post Operative Analgesia in Patients Undergoing Lower Abdominal Surgeries Receiving US Transversus Abdominis Plane Block (TAP) With Bupivacaine and Dexmetomidine vs Bupivacaine nd Dexmethasone
- ClinicalTrials.gov ID
- NCT07508202
- Acronym / sponsor ID
- F52/2024(ERRC)/PIMS
- Conditions
- Post Operative Analgesia, Dexmedetomidine, TAP Block
- Keywords
- Post opertive analgesia in lower abdominal surgeries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 26 Jun 2026 (actual)
- Study completion
- 26 Jun 2026 (actual)
- First posted
- 2 Apr 2026 (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.
Lower abdominal surgeries cause significant pain and can be managed by injecting local anesthetic agents between muscles of abdominal wall that can provide post operative pain relief and its duration can be prolonged by adding drugs to local anesthetic regimen
Detailed description
TAPP block can provide significant post operative analgesia following lower abdominal surgery and its duration can be prolonged by adding adjuvants to local anesthetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidine |
| Dexamethasone | Active comparator | Drug: Dexamethasone |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA I and ASA II BMI 25-35 kg/m2 Lower abdominal surgeries below L2-L3 leves
Key exclusion criteria (1 listed)
- Infection at block site Coagulopathy Antiplatelet
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 |
|---|---|---|
| Dexmedetomidine20 ml 0.25% Bupivacaine along with 0.5 Mcg/kg of Dexmedetomidine will be given in TAPP block bilaterally | Drug | Dexmedetomidine |
| Dexamethasone20 ml 0.25% Bupivacaine along with 4 mg of Dexamethasone will be given in TAPP block bilaterally | Drug | Dexamethasone |
Primary outcome
Resuce analgesia
Time frame: Time in the post operative period when patient first demands rescues analgesia will be noted in minutes
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 14 Jul 2026.
- BackgroundSobhy YS, Gadalla RR, Nofal WH, Saleh MAE, Abdou KM. A comparative study between the use of dexmedetomidine .vs dexamethasone as adjuvants to bupivacaine in ultrasound-guided transversus abdominis plane block for postoperative pain relief in patients undergoing lower abdominal surgeries. Anaesth. pain intensive care 2022;26(5):681-688
- Individual participant dataSharing planned: No. Hospital Ethical Committe doesnt allow
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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 Dexmedetomidine and Dexamethasone in people with Post Operative Analgesia and Dexmedetomidine, run by Pakistan Institute of Medical Sciences 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 1 inclusion and 1 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 14 Jul 2026. 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.
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?
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?
Resuce analgesia (time frame: Time in the post operative period when patient first demands rescues analgesia will be noted in minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07508202, which also lists 1 linked publication.
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 14 Jul 2026.