A Phase 4 interventional study of Dexmedetomidine & Bupivacaine. and fentanyl and bupivacaine in Postoperative Pain, sponsored by Allama Iqbal Teaching Hospital. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Allama Iqbal Teaching Hospital · Phase 4, Interventional, and Treatment
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 60 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Allama Iqbal Teaching Hospital is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive dexmedetomidine intrathecally
Drug: Dexmedetomidine & Bupivacaine.
Participants will receive fentanyl intrathecally
Drug: fentanyl and bupivacaine
Drug pages: Dexmedetomidine · Bupivacaine
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
Also known as: Precedex
Drug pages: Fentanyl · Bupivacaine
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.
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.
Time frame: From administration of spinal anesthesia, till 24 hours after surgery
Total Amount of Nalbuphine Used
Total dose of nalbuphine administered as rescue analgesia for postoperative pain, recorded in milligrams during the first 24 hours after surgery.
Time frame: From the end of surgery through 24 hours postoperatively
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2025 to primary completion in Jan 2026, 5 months.
Of 531 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 32. This study's 5 months is below that.
Counting every sponsor, half of 541 studies reached it within 16 months; a quarter within 8 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dexmedetomidine · Bupivacaine
Allama Iqbal Teaching Hospital