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
- 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 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ketorolac and Dexmedetomidine as An Adjunct to Lignocaine in Prevention of Tourniquet Induced Pain During Intravenous Regional Anesthesia
- ClinicalTrials.gov ID
- NCT07878962
- Acronym / sponsor ID
- Mayo9
- Conditions
- Tourniquet-induced Pain, Procedural Pain
- Keywords
- Tourniquet pain, Intravenous regional anesthesia, Bier block, Ketorolac, Dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mayo Hospital LahoreUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 15 Aug 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 16 Oct 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Experimental | Drug: Dexmedetomidine, Drug: LidocainePatients received dexmedetomidine 0.5 micrograms/kg with 0.5% lignocaine at 3 mg/kg for intravenous regional anesthesia. |
| Ketorolac Group | Active comparator | Drug: ketorolac, Drug: LidocainePatients received ketorolac 30 mg with 0.5% lignocaine at 3 mg/kg for intravenous regional anesthesia. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| DexmedetomidineDexmedetomidine 0.5 micrograms/kg was administered as an adjunct to lignocaine for prevention of tourniquet-induced pain during intravenous regional anesthesia. | Drug | Dexmedetomidine Group |
| ketorolacKetorolac 30 mg was administered as an adjunct to lignocaine for prevention of tourniquet-induced pain during intravenous regional anesthesia. | Drug | Ketorolac Group |
| LidocaineLidocaine 0.5% at 3 mg/kg was administered for intravenous regional anesthesia in both treatment groups. | Drug | Dexmedetomidine Group, Ketorolac Group |
Primary outcome
Mean Time to First Rescue Analgesic Requirement
Time frame: From tourniquet application until the first rescue analgesic requirement or the end of surgery.
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.
3 secondary outcomes
Tourniquet Pain Intensity
Time frame: At 15, 30, and 45 minutes after tourniquet application.
Time to Onset of Sensory Blockade
Time frame: From administration of the study drugs until sensory blockade was established, before surgery.
Time to Onset of Motor Blockade
Time frame: From administration of the study drugs until motor blockade was established, before surgery.
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 16 Oct 2026.
Related trials for Tourniquet-induced Pain
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.
Hamza Qaiser principal investigator
Mayo Hospital Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
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 3 inclusion and 5 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 16 Oct 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.
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?
Mean Time to First Rescue Analgesic Requirement (time frame: From tourniquet application until the first rescue analgesic requirement or the end of 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 16 Oct 2026.