Adjuvants, AnesthesiaNCT07294352
Intrathecal Nalbuphine Versus Intrathecal Tramadol in Subarachnoid Block for Lower Limb Orthopaedic Surgeries
A study testing Intrathecal tramadol with spinal anesthsia and Intrathecal nalbuphine and spinal anesthesia in people with Adjuvants, Anesthesia and Subarachnoid Block, run by CMH Lahore Medical College and Institute of Dentistry at 1 site in Pakistan.
Trial summary
This study compares the use of intrathecal nalbuphine versus intrathecal tramadol as adjuvant agents to local anaesthetics in subarachnoid block for lower-limb orthopaedic surgeries. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Adjuvants, Anesthesia, Subarachnoid Block
- What is being tested?
- Intrathecal tramadol with spinal anesthsia and Intrathecal nalbuphine and spinal anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2026to 1 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA Physical Status 1 and 2 Undergoing surgical correction of lower limb fracture
Who cannot join
- hypersensitivity to opioids or local anesthetics patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intrathecal Nalbuphine Versus Intrathecal Tramadol as Adjuvants in Subarachnoid Block for Lower Limb Orthopaedic Surgeries
This study compares the use of intrathecal nalbuphine versus intrathecal tramadol as adjuvant agents to local anaesthetics in subarachnoid block for lower-limb orthopaedic surgeries. The primary objective is to determine whether there is a meaningful difference between the two drugs in terms of quality and duration of intraoperative and postoperative analgesia. Secondary outcomes include onset and efficacy of sensory and motor block, time to first rescue analgesia, incidence of adverse effects, and perioperative hemodynamic stability. By evaluating these parameters, the study aims to identify which adjuvant provides superior analgesic benefits with fewer side effects in patients undergoing lower-limb orthopedic procedures.
Read the detailed description
The effectiveness of Intrathecal Nalbuphine 1mg versus Intrathecal Tramadol 20mg as adjuvant to 0.5% hyperbaric bupivacaine in Subarachnoid block for orthopaedic surgeries of the lower limbs is studied. Primary outcomes of the study are onset of sensory block, onset of motor block, intraoperative hemodynamic stability and postoperative analgesia measured on visual analog scale. Secondary outcomes were incidence of side-effects and the need for rescue analgesia.
- Conditions
- Adjuvants, Anesthesia, Subarachnoid Block
- Being tested
- Intrathecal tramadol with spinal anesthsia, Intrathecal nalbuphine and spinal anesthesia
- Keywords
- Subarachnoid block, Adjuvants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal tramadol with spinal anesthsiaDrug
intrathecal tramadol 20mg with Hyperbaric 0.5% bupivacaine
Intrathecal nalbuphine and spinal anesthesiaDrug
intrathecal nalbuphine 1mg with 0.5% Hyperbaric Bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Tramadol group | Active comparator | Intrathecal tramadol 20mg + bupivacaine 0.5% Receives: Drug: Intrathecal tramadol with spinal anesthsia |
| Intrathecal nalbuphine | Experimental | Intrathecal nalbuphine 1 mg + bupivacaine 0.5% Receives: Drug: Intrathecal nalbuphine and spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of spinal anesthesia
Time until first rescue analgesia at VAS <4. (Visual Analog scale measures subjective pain intensity on a continuous scale. Score 0 means no pain while 10 means most pain possible)
Measured: up to 24 hours post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start1 Jan 2026
- Primary completion1 Jul 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adjuvants, AnesthesiaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMH Lahore Medical College and Institute of Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294352
- Sponsor's protocol ID
- 566/2024
- Status last verified
- Mar 2026
- First submitted
- 8 Dec 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sharma A, Chaudhary S, Kumar M, Kapoor R. Comparison of nalbuphine versus fentanyl as intrathecal adjuvant to bupivacaine for orthopedic surgeries: A randomized controlled double-blind trial. J Anaesthesiol Clin Pharmacol. 2021 Oct-Dec;37(4):529-536. doi: 10.4103/joacp.JOACP_270_18. Epub 2022 Jan 6.
PubMed 35340949
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intrathecal Nalbuphine Versus Intrathecal Tramadol as Adjuvants in Subarachnoid Block for Lower Limb Orthopaedic Surgeries
- ClinicalTrials.gov ID
- NCT07294352
- Acronym / sponsor ID
- 566/2024
- Conditions
- Adjuvants, Anesthesia, Subarachnoid Block
- Keywords
- Subarachnoid block, Adjuvants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CMH Lahore Medical College and Institute of DentistryUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 19 Dec 2025 (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 compares the use of intrathecal nalbuphine versus intrathecal tramadol as adjuvant agents to local anaesthetics in subarachnoid block for lower-limb orthopaedic surgeries. The primary objective is to determine whether there is a meaningful difference between the two drugs in terms of quality and duration of intraoperative and postoperative analgesia. Secondary outcomes include onset and efficacy of sensory and motor block, time to first rescue analgesia, incidence of adverse effects, and perioperative hemodynamic stability. By evaluating these parameters, the study aims to identify which adjuvant provides superior analgesic benefits with fewer side effects in patients undergoing lower-limb orthopedic procedures.
Detailed description
The effectiveness of Intrathecal Nalbuphine 1mg versus Intrathecal Tramadol 20mg as adjuvant to 0.5% hyperbaric bupivacaine in Subarachnoid block for orthopaedic surgeries of the lower limbs is studied. Primary outcomes of the study are onset of sensory block, onset of motor block, intraoperative hemodynamic stability and postoperative analgesia measured on visual analog scale. Secondary outcomes were incidence of side-effects and the need for rescue analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tramadol group | Active comparator | Drug: Intrathecal tramadol with spinal anesthsiaIntrathecal tramadol 20mg + bupivacaine 0.5% |
| Intrathecal nalbuphine | Experimental | Drug: Intrathecal nalbuphine and spinal anesthesiaIntrathecal nalbuphine 1 mg + bupivacaine 0.5% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA Physical Status 1 and 2 Undergoing surgical correction of lower limb fracture
Key exclusion criteria (1 listed)
- hypersensitivity to opioids or local anesthetics patient refusal
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 |
|---|---|---|
| Intrathecal tramadol with spinal anesthsiaintrathecal tramadol 20mg with Hyperbaric 0.5% bupivacaine | Drug | Tramadol group |
| Intrathecal nalbuphine and spinal anesthesiaintrathecal nalbuphine 1mg with 0.5% Hyperbaric Bupivacaine | Drug | Intrathecal nalbuphine |
Primary outcome
Duration of spinal anesthesia
Time frame: up to 24 hours post operatively
Time until first rescue analgesia at VAS <4. (Visual Analog scale measures subjective pain intensity on a continuous scale. Score 0 means no pain while 10 means most pain possible)
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 11 Sep 2026.
- Background: PubMed 35340949Sharma A, Chaudhary S, Kumar M, Kapoor R. Comparison of nalbuphine versus fentanyl as intrathecal adjuvant to bupivacaine for orthopedic surgeries: A randomized controlled double-blind trial. J Anaesthesiol Clin Pharmacol. 2021 Oct-Dec;37(4):529-536. doi: 10.4103/joacp.JOACP_270_18. Epub 2022 Jan 6.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal tramadol with spinal anesthsia and Intrathecal nalbuphine and spinal anesthesia in people with Adjuvants, Anesthesia and Subarachnoid Block, run by CMH Lahore Medical College and Institute of Dentistry 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 1 inclusion and 1 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 11 Sep 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?
Duration of spinal anesthesia (time frame: up to 24 hours post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07294352, which also lists 1 linked publication.
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 11 Sep 2026.