Allama Iqbal Teaching Hospital
Dera Ghazi Khan, Punjab Province, 32200, Pakistan
NCT Number: NCT07770542
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 4
Dera Ghazi Khan, Punjab Province, 32200, Pakistan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Precedex
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.
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.
Time frame: From the end of surgery through 24 hours postoperatively
Total dose of nalbuphine administered as rescue analgesia for postoperative pain, recorded in milligrams during the first 24 hours after surgery.
Allama Iqbal Teaching Hospital
Other Gov
Comparison of Effective Analgesia Duration in Dexmedetomidine Versus Fentanyl as Adjuvants to Hyperbaric Bupivacaine for Unilateral Spinal Anesthesia in Lower Limb Orthopedic Surgeries
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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