Tourniquet-induced PainNCT07878962
Comparison of Ketorolac and Dexmedetomidine as An Adjunct to Lignocaine in Prevention of Tourniquet Induced Pain During Intravenous Regional Anesthesia
A study testing Dexmedetomidine, ketorolac and Lidocaine in people with Tourniquet-induced Pain and Procedural Pain, run by Mayo Hospital Lahore at 1 site in Pakistan.
Trial summary
This study compared ketorolac and dexmedetomidine when added to lignocaine to prevent pain caused by a tourniquet during intravenous regional anesthesia. This technique involved injecting a local anesthetic into a vein to numb an arm or leg for surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tourniquet-induced Pain, Procedural Pain
- What is being tested?
- Dexmedetomidine, ketorolac and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2026to 15 Aug 2026
- Phase
- Interventional
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18-60 years undergoing distal upper or lower limb surgeries utilizing IVRA.
- Both male and female patients.
- ASA physical status 1 and 2
Who cannot join
- H/O IHD, arrhythmias, uncontrolled hypertension/diabetes as determined on history and medical records.
- Patients with anatomical abnormalities.
- Pregnant and nursing women.
- Known allergies to drugs used in the study.
- Prolonged surgical procedure more than 1.5 hours.
Trial locations and contacts
1 site in 1 country.
About this study
This study compared ketorolac and dexmedetomidine when added to lignocaine to prevent pain caused by a tourniquet during intravenous regional anesthesia. This technique involved injecting a local anesthetic into a vein to numb an arm or leg for surgery. A tourniquet, a tight cuff placed around the limb, restricted blood flow but could cause pain during the procedure.
The study was conducted at Mayo Hospital, Lahore, and was designed to include 70 patients aged 18-60 years undergoing surgery on the lower part of an arm or leg. Two treatment groups of 35 patients each received lignocaine with either dexmedetomidine or ketorolac. Pain was assessed on a scale from 0 to 10 at 15, 30, and 45 minutes after tourniquet application. Additional pain relief was administered when the pain score reached 4 or higher.
- Conditions
- Tourniquet-induced Pain, Procedural Pain
- Being tested
- Dexmedetomidine, ketorolac, Lidocaine
- Keywords
- Tourniquet pain, Intravenous regional anesthesia, Bier block, Ketorolac, Dexmedetomidine
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine 0.5 micrograms/kg was administered as an adjunct to lignocaine for prevention of tourniquet-induced pain during intravenous regional anesthesia.
ketorolacDrug
Ketorolac 30 mg was administered as an adjunct to lignocaine for prevention of tourniquet-induced pain during intravenous regional anesthesia.
LidocaineDrug
Lidocaine 0.5% at 3 mg/kg was administered for intravenous regional anesthesia in both treatment groups.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Experimental | Patients received dexmedetomidine 0.5 micrograms/kg with 0.5% lignocaine at 3 mg/kg for intravenous regional anesthesia. Receives: Drug: Dexmedetomidine; Drug: Lidocaine |
| Ketorolac Group | Active comparator | Patients received ketorolac 30 mg with 0.5% lignocaine at 3 mg/kg for intravenous regional anesthesia. Receives: Drug: ketorolac; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Time to First Rescue Analgesic Requirement
The mean interval, in minutes, from tourniquet application until the first requirement for rescue analgesia was compared between the treatment groups. Rescue analgesia was required when the Visual Analog Scale pain score reached 4 or higher and was administered as intravenous nalbuphine 0.07 mg/kg.
Measured: From tourniquet application until the first rescue analgesic requirement or the end of surgery.
Secondary outcomes (3)
Tourniquet Pain Intensity
Tourniquet-related pain was assessed using the Visual Analog Scale. Mean pain scores were compared between the treatment groups, with higher scores representing greater pain intensity.
Measured: At 15, 30, and 45 minutes after tourniquet application.
Time to Onset of Sensory Blockade
The interval, in minutes, from administration of the study drugs until sensory blockade was established was recorded. Sensory blockade was assessed using the pinprick sensation test.
Measured: From administration of the study drugs until sensory blockade was established, before surgery.
Time to Onset of Motor Blockade
The interval, in minutes, from administration of the study drugs until motor blockade was established was recorded. Motor blockade was assessed by the absence of voluntary movements in the operative limb.
Measured: From administration of the study drugs until motor blockade was established, before surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start15 Feb 2026
- Primary completion15 Aug 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourniquet-induced 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Hospital Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adeel Ahmed, Mayo Hospital Lahore
- Investigators
- Hamza Qaiser, Principal investigator, Mayo Hospital Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878962
- Sponsor's protocol ID
- Mayo9
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No