Postoperative PainPhase 4NCT07770542
Comparison of Pain Relief Duration With Dexmedetomidine Versus Fentanyl Added to Spinal Anesthesia in Patients Undergoing Lower Limb Orthopedic Surgery
A Phase 4 study testing Dexmedetomidine & Bupivacaine. and fentanyl and bupivacaine in people with Postoperative Pain, run by Allama Iqbal Teaching Hospital at 1 site in Pakistan.
Trial summary
The goal of this randomized clinical trial is to compare how long effective pain relief lasts when dexmedetomidine or fentanyl is added to hyperbaric bupivacaine during spinal anesthesia for lower limb orthopedic surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Dexmedetomidine & Bupivacaine. and fentanyl and bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2025to 30 Jan 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA status I and II
- Orthopedic leg operations under spinal anesthesia
Who cannot join
- Spinal deformity
- Coagulopathy (INR >1.5)
- Allergic reaction to local anesthetic
- Recent heart attack (≤3-months)
- With neurological diseases
- Pulmonary diseases
- Major liver or kidney disorders and infection of skin at the block site
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Allama Iqbal Teaching Hospital
Dera Ghazi Khan, Punjab Province, 32200
About this study
Official title: Comparison of Effective Analgesia Duration in Dexmedetomidine Versus Fentanyl as Adjuvants to Hyperbaric Bupivacaine for Unilateral Spinal Anesthesia in Lower Limb Orthopedic Surgeries
The goal of this randomized clinical trial is to compare how long effective pain relief lasts when dexmedetomidine or fentanyl is added to hyperbaric bupivacaine during spinal anesthesia for lower limb orthopedic surgery.
The main question the study aims to answer is:
Read more
Does adding dexmedetomidine to hyperbaric bupivacaine provide longer-lasting effective pain relief after surgery than adding fentanyl?
The study will include 60 adults aged 18-65 years who are classified as ASA Grade I or II and are undergoing lower limb orthopedic surgery under spinal anesthesia. Participants will be randomly assigned to one of two groups.
Participants in the dexmedetomidine group will receive dexmedetomidine with hyperbaric bupivacaine.
Participants in the fentanyl group will receive fentanyl with hyperbaric bupivacaine.
After surgery, participants will be monitored for pain using a visual analogue scale (VAS), ranging from 0 (no pain) to 10 (severe pain). Pain will be assessed hourly during the first 12 hours and subsequently according to the study protocol. If the VAS pain score is greater than 3, nalbuphine will be given as rescue pain medicine.
The study will measure the time from administration of spinal anesthesia until the participant first requires rescue pain medicine. The total amount of nalbuphine required after surgery will also be recorded.
The study hypothesis is that adding dexmedetomidine to hyperbaric bupivacaine will provide a longer duration of effective pain relief than adding fentanyl.
- Conditions
- Postoperative Pain
- Being tested
- Dexmedetomidine & Bupivacaine., fentanyl and bupivacaine
- Keywords
- Dexmedetomidine, Fentanyl, Hyperbaric Bupivacaine, Intrathecal Analgesia, Lower Limb Orthopedic Surgery, Spinal Anesthesia, Postoperative Pain, Unilateral Spinal Anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine & Bupivacaine.Drug
Also called Precedex
0.5 µg dexmedetomidine (0.5 mL) added to 3 mL of 0.5% bupivacaine and administered intrathecally for spinal anesthesia during lower limb orthopedic surgery
fentanyl and bupivacaineDrug
25 µg fentanyl (0.5 mL) added to 3 mL of 0.5% bupivacaine and administered intrathecally for spinal anesthesia during lower limb orthopedic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Experimental | Participants will receive dexmedetomidine intrathecally Receives: Drug: Dexmedetomidine & Bupivacaine. |
| Fentanyl Group | Active comparator | Participants will receive fentanyl intrathecally Receives: Drug: fentanyl and bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Effective Analgesia
Time from administration of the intrathecal study medication to the first requirement for rescue analgesia, defined as a postoperative visual analogue scale (VAS) pain score >3. Duration will be recorded in minutes.
Measured: From administration of spinal anesthesia, till 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Aug 2025
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allama Iqbal Teaching Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Merzia Tu Zahra, Allama Iqbal Teaching Hospital
- Investigators
- Aushtar A Naqvi, FCPS, Study chair, Allama Iqbal Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770542
- Sponsor's protocol ID
- U1111-1345-0217
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 18 Aug 2026
- 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 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effective Analgesia Duration in Dexmedetomidine Versus Fentanyl as Adjuvants to Hyperbaric Bupivacaine for Unilateral Spinal Anesthesia in Lower Limb Orthopedic Surgeries
- ClinicalTrials.gov ID
- NCT07770542
- Acronym / sponsor ID
- U1111-1345-0217
- Conditions
- Postoperative Pain
- Keywords
- Dexmedetomidine, Fentanyl, Hyperbaric Bupivacaine, Intrathecal Analgesia, Lower Limb Orthopedic Surgery, Spinal Anesthesia, Postoperative Pain, Unilateral Spinal Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Allama Iqbal Teaching HospitalOther government
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 18 Aug 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 goal of this randomized clinical trial is to compare how long effective pain relief lasts when dexmedetomidine or fentanyl is added to hyperbaric bupivacaine during spinal anesthesia for lower limb orthopedic surgery.
The main question the study aims to answer is:
Does adding dexmedetomidine to hyperbaric bupivacaine provide longer-lasting effective pain relief after surgery than adding fentanyl?
The study will include 60 adults aged 18-65 years who are classified as ASA Grade I or II and are undergoing lower limb orthopedic surgery under spinal anesthesia. Participants will be randomly assigned to one of two groups.
Participants in the dexmedetomidine group will receive dexmedetomidine with hyperbaric bupivacaine.
Participants in the fentanyl group will receive fentanyl with hyperbaric bupivacaine.
After surgery, participants will be monitored for pain using a visual analogue scale (VAS), ranging from 0 (no pain) to 10 (severe pain). Pain will be assessed hourly during the first 12 hours and subsequently according to the study protocol. If the VAS pain score is greater than 3, nalbuphine will be given as rescue pain medicine.
The study will measure the time from administration of spinal anesthesia until the participant first requires rescue pain medicine. The total amount of nalbuphine required after surgery will also be recorded.
The study hypothesis is that adding dexmedetomidine to hyperbaric bupivacaine will provide a longer duration of effective pain relief than adding fentanyl.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Experimental | Drug: Dexmedetomidine & Bupivacaine.Participants will receive dexmedetomidine intrathecally |
| Fentanyl Group | Active comparator | Drug: fentanyl and bupivacaineParticipants will receive fentanyl intrathecally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA status I and II
- Orthopedic leg operations under spinal anesthesia
Key exclusion criteria (7 listed)
- Spinal deformity
- Coagulopathy (INR >1.5)
- Allergic reaction to local anesthetic
- Recent heart attack (≤3-months)
- With neurological diseases
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 |
|---|---|---|
| Dexmedetomidine & Bupivacaine.Also: Precedex0.5 µg dexmedetomidine (0.5 mL) added to 3 mL of 0.5% bupivacaine and administered intrathecally for spinal anesthesia during lower limb orthopedic surgery | Drug | Dexmedetomidine Group |
| fentanyl and bupivacaine25 µg fentanyl (0.5 mL) added to 3 mL of 0.5% bupivacaine and administered intrathecally for spinal anesthesia during lower limb orthopedic surgery. | Drug | Fentanyl Group |
Primary outcome
Duration of Effective Analgesia
Time frame: From administration of spinal anesthesia, till 24 hours after surgery
Time from administration of the intrathecal study medication to the first requirement for rescue analgesia, defined as a postoperative visual analogue scale (VAS) pain score >3. Duration will be recorded 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 18 Aug 2026.
- 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.
Aushtar A Naqvi, FCPS study chair
Allama Iqbal Teaching Hospital
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 & Bupivacaine. and fentanyl and bupivacaine in people with Postoperative Pain, run by Allama Iqbal Teaching Hospital 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 2 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 18 Aug 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?
Duration of Effective Analgesia (time frame: From administration of spinal anesthesia, till 24 hours after 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 18 Aug 2026.