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NCT Number: NCT07770542

Comparison of Pain Relief Duration With Dexmedetomidine Versus Fentanyl Added to Spinal Anesthesia in Patients Undergoing Lower Limb Orthopedic Surgery

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Allama Iqbal Teaching Hospital

Dera Ghazi Khan, Punjab Province, 32200, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA status I and II
  • Orthopedic leg operations under spinal anesthesia

Exclusion criteria

  • 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

Treatment and study plan

Dexmedetomidine & Bupivacaine.

Drug

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

Fentanyl and Bupivacaine

Drug

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.

Primary outcomes

  1. 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.

Other outcomes

  1. Total Amount of Nalbuphine Used

    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.

Sponsors and collaborators

Lead sponsor

Allama Iqbal Teaching Hospital

Other Gov

Registry information

Official study title

Comparison of Effective Analgesia Duration in Dexmedetomidine Versus Fentanyl as Adjuvants to Hyperbaric Bupivacaine for Unilateral Spinal Anesthesia in Lower Limb Orthopedic Surgeries

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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