Duration of AnalgesiaEarly Phase 1DEX-BUPNCT07651488
Evaluation of Intrathecal Hyperbaric Bupivacaine With Dexmedetomidine in Adults Undergoing Perianal Surgery
A Early Phase 1 study testing Dexmedetomidine and Hyperbaric bupivacaine % 0.5 in people with Duration of Analgesia and Pain Score, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
Trial summary
The aim of this study is to evaluate the effects of adding 5-mcg dexmedetomidine to hyperbaric bupivacaine in our population as it has never been published before, to enhance the duration of analgesia after perianal procedures requiring spinal saddle block and, thus reducing requirements of postoperative analgesics. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Duration of Analgesia, Pain Score
- What is being tested?
- Dexmedetomidine and Hyperbaric bupivacaine % 0.5
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Mar 2023to 28 Sep 2023
- Phase
- Early Phase 1
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective perianal surgery under spinal saddle block were included in the study.
- Age between 40-80 years
- ASA status I and II
Who cannot join
- Pregnant women
- Patient with coagulopathy
- Infection at or near the needle insertion site
- Allergy to the trial drug
- Patient with chronic pain
- Cognitive impairment
- Patient with known drug or substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the effects of adding 5-mcg dexmedetomidine to hyperbaric bupivacaine in our population as it has never been published before, to enhance the duration of analgesia after perianal procedures requiring spinal saddle block and, thus reducing requirements of postoperative analgesics.
- Conditions
- Duration of Analgesia, Pain Score
- Being tested
- Dexmedetomidine, Hyperbaric bupivacaine % 0.5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
dexmedetomidine 5 microgram added to 5 mg of 0.5% hyperbaric bupivacaine in dextrose injection
Hyperbaric bupivacaine % 0.5Drug
5 mg of 0.5% hyperbaric bupivacaine in dextrose injection alone
| Study group | Role | What they receive |
|---|---|---|
| Dexemedetomidine | Experimental | Experimental group received intrathecal dexmedetomidine 5 microgram added to 5 mg of 0.5% hyperbaric bupivacaine in dextrose injection Receives: Drug: Dexmedetomidine |
| Hyperbaric bupivacaine | Active comparator | Active comparator had 5 mg of 0.5% hyperbaric bupivacaine in dextrose injection alone Receives: Drug: Hyperbaric bupivacaine % 0.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesia
duration of analgesia was assessed from induction of anesthesia till patient discharge
Measured: 0 hour to 4 hours
Secondary outcomes (1)
Pain score
Pain will be assessed using Numeric Rating Scale (NRS) scale ranging from 0-10; 0 being no pain and 10 indicates the worst pain
Measured: Two hours post surgery till 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start29 Mar 2023
- Primary completion28 Sep 2023
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duration of 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat National Hospital & Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahad Ali Tunio, Liaquat National Hospital & Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651488
- Sponsor's protocol ID
- IRB-App#0792-2022-LNH-ERC
- Acronym
- DEX-BUP
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intrathecal Hyperbaric Bupivacaine With Dexmedetomidine in Adults Undergoing Perianal Surgery
- ClinicalTrials.gov ID
- NCT07651488
- Acronym / sponsor ID
- DEX-BUP / IRB-App#0792-2022-LNH-ERC
- Conditions
- Duration of Analgesia, Pain Score
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 16 Jun 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.
The aim of this study is to evaluate the effects of adding 5-mcg dexmedetomidine to hyperbaric bupivacaine in our population as it has never been published before, to enhance the duration of analgesia after perianal procedures requiring spinal saddle block and, thus reducing requirements of postoperative analgesics.
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 |
|---|---|---|
| Dexemedetomidine | Experimental | Drug: DexmedetomidineExperimental group received intrathecal dexmedetomidine 5 microgram added to 5 mg of 0.5% hyperbaric bupivacaine in dextrose injection |
| Hyperbaric bupivacaine | Active comparator | Drug: Hyperbaric bupivacaine % 0.5Active comparator had 5 mg of 0.5% hyperbaric bupivacaine in dextrose injection alone |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing elective perianal surgery under spinal saddle block were included in the study.
- Age between 40-80 years
- ASA status I and II
Key exclusion criteria (7 listed)
- Pregnant women
- Patient with coagulopathy
- Infection at or near the needle insertion site
- Allergy to the trial drug
- Patient with chronic pain
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 |
|---|---|---|
| Dexmedetomidinedexmedetomidine 5 microgram added to 5 mg of 0.5% hyperbaric bupivacaine in dextrose injection | Drug | Dexemedetomidine |
| Hyperbaric bupivacaine % 0.55 mg of 0.5% hyperbaric bupivacaine in dextrose injection alone | Drug | Hyperbaric bupivacaine |
Primary outcome
Duration of analgesia
Time frame: 0 hour to 4 hours
duration of analgesia was assessed from induction of anesthesia till patient discharge
1 secondary outcome
Pain score
Time frame: Two hours post surgery till 24 hours
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 16 Jun 2026.
- Effects of Adding Intrathecal Dexmedetomidine to Hyperbaric Bupivacaine for Saddle Spinal Block in Adults Undergoing Peri-anal SurgeriesLink provided by the sponsor.
- Effect Of Dexmedetomidine Added To Intrathecal Hyperbaric Bupivacaine Versus Bupivacaine Alone On Mean Postoperative Analgesia After Spinal Saddle BlockLink provided by the sponsor.
- EFFECT OF ADDING DEXMEDETOMIDINE VERSUS FENTANYL TO INTRATHECAL HYPERBARIC BUPIVACAINE ON SPINAL BLOCK FOR INFRAUMBILICAL ELECTIVE SURGERIESLink provided by the sponsor.
- Effects of intravenous dexmedetomidine on hyperbaric bupivacaine spinal anesthesia: A randomized studyLink provided by the sponsor.
- 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.
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 Early Phase 1 study testing Dexmedetomidine and Hyperbaric bupivacaine % 0.5 in people with Duration of Analgesia and Pain Score, run by Liaquat National Hospital & 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 7 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 16 Jun 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Duration of analgesia (time frame: 0 hour to 4 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 16 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.