Postoperative PainPhase 4NCT07907666
Ropivacaine Alone Versus Ropivacaine Plus Lidocaine With or Without Epinephrine for Supraclavicular Brachial Plexus Block in Upper Limb Orthopedic Surgery
A Phase 4 study testing ropivacaine, lidocaine and lidocaine with epinephrine in people with Postoperative Pain and Upper Extremity Fracture, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
This randomized controlled trial compared three local anesthetic solutions for ultrasound-guided supraclavicular brachial plexus block in adults aged 18 to 59 years undergoing upper limb orthopedic and trauma surgery at a general hospital of the Mexican Social Security Institute (IMSS) in Aguascalientes, Mexico. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Postoperative Pain, Upper Extremity Fracture, Anesthesia, Conduction
- What is being tested?
- ropivacaine, lidocaine and lidocaine with epinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteMexico
- Study dates
- 2 Mar 2026to 17 Apr 2026
- Phase
- Phase 4
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults of any sex aged 18 to 59 years.
- Scheduled for upper limb orthopedic or trauma surgery under brachial plexus block at Hospital General de Zona No. 3, IMSS, Aguascalientes.
- American Society of Anesthesiologists (ASA) physical status I to III.
- Signed informed consent.
Who cannot join
- Allergy to ropivacaine, lidocaine or epinephrine.
- Emergency surgery.
- Uncooperative patients.
- Previous brachial plexus injury.
- Upper limb neuropathy.
- Inability to read or visual impairment preventing use of the pain scale.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital General de Zona No. 3, Instituto Mexicano del Seguro Social
Aguascalientes, Aguascalientes, 20908
About this study
Official title: Analgesic Effectiveness of Two Combinations of Local Anesthetics in Brachial Plexus Block in Patients Aged 18 to 59 Years Undergoing Orthopedic and Trauma Surgery at General Hospital of Zone No. 3, IMSS, Aguascalientes: a Randomized Controlled Trial
This randomized controlled trial compared three local anesthetic solutions for ultrasound-guided supraclavicular brachial plexus block in adults aged 18 to 59 years undergoing upper limb orthopedic and trauma surgery at a general hospital of the Mexican Social Security Institute (IMSS) in Aguascalientes, Mexico. Participants were randomly assigned to receive 30 mL of ropivacaine 0.375% alone, ropivacaine 0.375% plus lidocaine 1%, or ropivacaine 0.375% plus lidocaine 1% with epinephrine. The main question was whether adding lidocaine, with or without epinephrine, to ropivacaine improves postoperative analgesia. Pain intensity (0 to 10 Numeric Rating Scale) at 6 hours after surgery was the primary outcome. Secondary outcomes were pain at 0 and 12 hours, need for rescue analgesia, analgesic and opioid consumption, motor block (modified Bromage scale) and adverse events during the first 12 postoperative hours. Block onset time was also recorded.
Read the detailed description
Background. Mixing a fast-onset local anesthetic with a long-acting agent is common practice in peripheral nerve blocks to shorten block onset, but its effect on the quality and duration of analgesia is controversial, and no study had evaluated these mixtures in patients of the Mexican Social Security Institute.
Design. Single-center, superiority, randomized controlled trial with three parallel groups (1:1:1 allocation) and blinded outcome assessment, conducted at Hospital General de Zona No. 3, IMSS, Aguascalientes, Mexico, from January 2 to April 16, 2026. The trial was approved by the local research and ethics committees (registration R-2026-101-005) and all participants gave written informed consent. This trial was registered retrospectively, after completion of enrollment.
Interventions. All participants received an ultrasound-guided supraclavicular brachial plexus block with a total volume of 30 mL: group C, 15 mL of ropivacaine 0.75% plus 15 mL of sterile water (ropivacaine 0.375%); group L, 15 mL of ropivacaine 0.75% plus 15 mL of lidocaine 2% (ropivacaine 0.375% plus lidocaine 1%); group E, 15 mL of ropivacaine 0.75% plus 15 mL of lidocaine 2% with epinephrine (ropivacaine 0.375% plus lidocaine 1%, final epinephrine concentration 2.5 micrograms/mL, 1:400,000). No perineural adjuvants were used. Blocks were performed by attending anesthesiologists and anesthesiology residents assigned to each operating room according to the department's daily roster. All participants received the institution's standard intraoperative sedation and analgesia (a corticosteroid, a nonsteroidal anti-inflammatory drug, acetaminophen, midazolam and fentanyl), except when a drug was contraindicated.
Randomization and blinding. The principal investigator generated the allocation sequence in Excel for folios 1 to 138. Allocation was concealed in sealed envelopes identified by folio number, kept by the thesis investigator together with the study syringes and opened immediately before the block. Outcomes were assessed by the attending anesthesiologists and residents in charge of each participant, who were unaware of group allocation.
Outcomes. Pain intensity was measured with the 0 to 10 Numeric Rating Scale and motor block with the modified Bromage scale for the upper limb (0 = full movement, 3 = complete motor block) at 0, 6 and 12 hours after the end of surgery; rescue analgesics, opioid use and adverse events were recorded at the same time points. Block onset time was marked on the monitor from local anesthetic administration to onset of anesthesia and recorded in the anesthesia record.
Withdrawal criteria. Withdrawal of consent, failed block (need for general anesthesia or additional intraoperative analgesia attributable to block failure), discharge before 6 postoperative hours, and block-related complications (puncture-site hematoma, pneumothorax, local anesthetic systemic toxicity, persistent neurological deficit or allergic reaction).
Sample size and analysis. A sample of 138 participants (46 per group) was calculated with G*Power (alpha 0.05, power 0.80, effect size d = 0.5). Analysis followed the intention-to-treat principle. Groups were compared with the Kruskal-Wallis test or one-way ANOVA with Bonferroni-corrected pairwise comparisons, and with the chi-square or Fisher-Freeman-Halton tests for categorical variables; effect estimates are reported with 95% confidence intervals. A p value below 0.05 was considered significant.
- Being tested
- ropivacaine, lidocaine, lidocaine with epinephrine
- Keywords
- Brachial Plexus Block, Supraclavicular Block, Ropivacaine, Lidocaine, Epinephrine, Local Anesthetic Mixture, Regional Anesthesia, Postoperative Analgesia, Orthopedic Surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaineDrug
Ropivacaine 112.5 mg (15 mL of 0.75%) administered perineurally in an ultrasound-guided supraclavicular brachial plexus block, diluted to a total volume of 30 mL.
lidocaineDrug
Lidocaine 300 mg (15 mL of 2%) mixed with ropivacaine for perineural administration in the supraclavicular brachial plexus block (final lidocaine concentration 1%).
lidocaine with epinephrineDrug
Lidocaine 300 mg with epinephrine 75 micrograms (15 mL of lidocaine 2% with epinephrine) mixed with ropivacaine for perineural administration (final concentrations: lidocaine 1%, epinephrine 2.5 micrograms/mL).
| Study group | Role | What they receive |
|---|---|---|
| Group C: Ropivacaine 0.375% | Active comparator | Ultrasound-guided supraclavicular brachial plexus block with 30 mL of ropivacaine 0.375% (15 mL of ropivacaine 0.75% plus 15 mL of sterile water for injection), single perineural injection. Receives: Drug: ropivacaine |
| Group L: Ropivacaine 0.375% + Lidocaine 1% | Experimental | Ultrasound-guided supraclavicular brachial plexus block with 30 mL of ropivacaine 0.375% plus lidocaine 1% (15 mL of ropivacaine 0.75% plus 15 mL of lidocaine 2%), single perineural injection. Receives: Drug: lidocaine |
| Group E: Ropivacaine 0.375% + Lidocaine 1% With Epinephrine | Experimental | Ultrasound-guided supraclavicular brachial plexus block with 30 mL of ropivacaine 0.375% plus lidocaine 1% with epinephrine (15 mL of ropivacaine 0.75% plus 15 mL of lidocaine 2% with epinephrine; final epinephrine concentration 2.5 micrograms/mL, 75 micrograms total), single perineural injection. Receives: Drug: lidocaine with epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity at 6 Hours
Pain intensity measured with the 11-point Numeric Rating Scale (NRS), from 0 (no pain) to 10 (worst imaginable pain), compared among the three groups.
Measured: 6 hours after the end of surgery
Secondary outcomes (6)
Postoperative Pain Intensity at 0 and 12 Hours
Pain intensity measured with the 11-point Numeric Rating Scale (NRS), from 0 (no pain) to 10 (worst imaginable pain).
Measured: Immediately after the end of surgery (0 hours) and 12 hours after the end of surgery
Number of Participants Requiring Rescue Analgesia (Duration of Analgesia)
Number of participants who received rescue analgesia at each assessment; participants without rescue at 6 hours were considered to have an analgesia duration of at least 6 hours.
Measured: At 0, 6 and 12 hours after the end of surgery
Rescue Analgesic Consumption by Drug Type
Number of participants receiving each rescue analgesic (acetaminophen, ketorolac, diclofenac, lysine clonixinate or opioids) and dose administered.
Measured: Up to 12 hours after the end of surgery
Number of Participants Receiving Postoperative Opioids
Number of participants who received at least one opioid
Measured: Up to 12 hours after the end of surgery
Upper Limb Motor Block (Modified Bromage Scale)
Motor block of the blocked upper limb graded with the modified Bromage scale: 0 = full movement, 1 = decreased strength, 2 = partial movement, 3 = complete motor block.
Measured: At 0, 6 and 12 hours after the end of surgery
Number of Participants With Block-Related Adverse Events
Nausea, vomiting, paresthesia, puncture-site hematoma, Horner syndrome, dyspnea or phrenic nerve block, and local anesthetic systemic toxicity.
Measured: Up to 12 hours after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start2 Mar 2026
- Primary completion16 Apr 2026
- Study completion17 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm, parallel-group randomized controlled trial with 1:1:1 allocation. Adults aged 18 to 59 years scheduled for upper limb orthopedic or trauma surgery under ultrasound-guided supraclavicular brachial plexus block were randomly assigned to one of three local anesthetic mixtures, all in a total volume of 30 mL: ropivacaine 0.375% alone (Group C, active comparator), ropivacaine 0.375% plus lidocaine 1% (Group L), or ropivacaine 0.375% plus lidocaine 1% with epinephrine 2.5 micrograms/mL (Group E). The principal investigator generated the allocation sequence in Excel for folios 1 to 138; allocation was concealed in sealed envelopes identified by folio number and opened immediately before the block. Each participant received a single block and was followed until 12 hours after surgery. Sedation and multimodal analgesia were standardized across groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Cristina González Ramírez, Instituto Mexicano del Seguro Social
- Investigators
- Cristina González Ramírez, MD, PhD, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907666
- Sponsor's protocol ID
- R-2026-101-005
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data underlying the results reported (baseline characteristics, pain scores, motor block, rescue analgesia and adverse events), together with the data dictionary, study protocol, statistical analysis plan, informed consent form and analytic code.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effectiveness of Two Combinations of Local Anesthetics in Brachial Plexus Block in Patients Aged 18 to 59 Years Undergoing Orthopedic and Trauma Surgery at General Hospital of Zone No. 3, IMSS, Aguascalientes: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07907666
- Acronym / sponsor ID
- R-2026-101-005
- Keywords
- Brachial Plexus Block, Supraclavicular Block, Ropivacaine, Lidocaine, Epinephrine, Local Anesthetic Mixture, Regional Anesthesia, Postoperative Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 17 Apr 2026 (actual)
- First posted
- 30 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 randomized controlled trial compared three local anesthetic solutions for ultrasound-guided supraclavicular brachial plexus block in adults aged 18 to 59 years undergoing upper limb orthopedic and trauma surgery at a general hospital of the Mexican Social Security Institute (IMSS) in Aguascalientes, Mexico. Participants were randomly assigned to receive 30 mL of ropivacaine 0.375% alone, ropivacaine 0.375% plus lidocaine 1%, or ropivacaine 0.375% plus lidocaine 1% with epinephrine. The main question was whether adding lidocaine, with or without epinephrine, to ropivacaine improves postoperative analgesia. Pain intensity (0 to 10 Numeric Rating Scale) at 6 hours after surgery was the primary outcome. Secondary outcomes were pain at 0 and 12 hours, need for rescue analgesia, analgesic and opioid consumption, motor block (modified Bromage scale) and adverse events during the first 12 postoperative hours. Block onset time was also recorded.
Detailed description
Background. Mixing a fast-onset local anesthetic with a long-acting agent is common practice in peripheral nerve blocks to shorten block onset, but its effect on the quality and duration of analgesia is controversial, and no study had evaluated these mixtures in patients of the Mexican Social Security Institute.
Design. Single-center, superiority, randomized controlled trial with three parallel groups (1:1:1 allocation) and blinded outcome assessment, conducted at Hospital General de Zona No. 3, IMSS, Aguascalientes, Mexico, from January 2 to April 16, 2026. The trial was approved by the local research and ethics committees (registration R-2026-101-005) and all participants gave written informed consent. This trial was registered retrospectively, after completion of enrollment.
Interventions. All participants received an ultrasound-guided supraclavicular brachial plexus block with a total volume of 30 mL: group C, 15 mL of ropivacaine 0.75% plus 15 mL of sterile water (ropivacaine 0.375%); group L, 15 mL of ropivacaine 0.75% plus 15 mL of lidocaine 2% (ropivacaine 0.375% plus lidocaine 1%); group E, 15 mL of ropivacaine 0.75% plus 15 mL of lidocaine 2% with epinephrine (ropivacaine 0.375% plus lidocaine 1%, final epinephrine concentration 2.5 micrograms/mL, 1:400,000). No perineural adjuvants were used. Blocks were performed by attending anesthesiologists and anesthesiology residents assigned to each operating room according to the department's daily roster. All participants received the institution's standard intraoperative sedation and analgesia (a corticosteroid, a nonsteroidal anti-inflammatory drug, acetaminophen, midazolam and fentanyl), except when a drug was contraindicated.
Randomization and blinding. The principal investigator generated the allocation sequence in Excel for folios 1 to 138. Allocation was concealed in sealed envelopes identified by folio number, kept by the thesis investigator together with the study syringes and opened immediately before the block. Outcomes were assessed by the attending anesthesiologists and residents in charge of each participant, who were unaware of group allocation.
Outcomes. Pain intensity was measured with the 0 to 10 Numeric Rating Scale and motor block with the modified Bromage scale for the upper limb (0 = full movement, 3 = complete motor block) at 0, 6 and 12 hours after the end of surgery; rescue analgesics, opioid use and adverse events were recorded at the same time points. Block onset time was marked on the monitor from local anesthetic administration to onset of anesthesia and recorded in the anesthesia record.
Withdrawal criteria. Withdrawal of consent, failed block (need for general anesthesia or additional intraoperative analgesia attributable to block failure), discharge before 6 postoperative hours, and block-related complications (puncture-site hematoma, pneumothorax, local anesthetic systemic toxicity, persistent neurological deficit or allergic reaction).
Sample size and analysis. A sample of 138 participants (46 per group) was calculated with G*Power (alpha 0.05, power 0.80, effect size d = 0.5). Analysis followed the intention-to-treat principle. Groups were compared with the Kruskal-Wallis test or one-way ANOVA with Bonferroni-corrected pairwise comparisons, and with the chi-square or Fisher-Freeman-Halton tests for categorical variables; effect estimates are reported with 95% confidence intervals. A p value below 0.05 was considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm, parallel-group randomized controlled trial with 1:1:1 allocation. Adults aged 18 to 59 years scheduled for upper limb orthopedic or trauma surgery under ultrasound-guided supraclavicular brachial plexus block were randomly assigned to one of three local anesthetic mixtures, all in a total volume of 30 mL: ropivacaine 0.375% alone (Group C, active comparator), ropivacaine 0.375% plus lidocaine 1% (Group L), or ropivacaine 0.375% plus lidocaine 1% with epinephrine 2.5 micrograms/mL (Group E). The principal investigator generated the allocation sequence in Excel for folios 1 to 138; allocation was concealed in sealed envelopes identified by folio number and opened immediately before the block. Each participant received a single block and was followed until 12 hours after surgery. Sedation and multimodal analgesia were standardized across groups.
| Arm | Type | Receives |
|---|---|---|
| Group C: Ropivacaine 0.375% | Active comparator | Drug: ropivacaineUltrasound-guided supraclavicular brachial plexus block with 30 mL of ropivacaine 0.375% (15 mL of ropivacaine 0.75% plus 15 mL of sterile water for injection), single perineural injection. |
| Group L: Ropivacaine 0.375% + Lidocaine 1% | Experimental | Drug: lidocaineUltrasound-guided supraclavicular brachial plexus block with 30 mL of ropivacaine 0.375% plus lidocaine 1% (15 mL of ropivacaine 0.75% plus 15 mL of lidocaine 2%), single perineural injection. |
| Group E: Ropivacaine 0.375% + Lidocaine 1% With Epinephrine | Experimental | Drug: lidocaine with epinephrineUltrasound-guided supraclavicular brachial plexus block with 30 mL of ropivacaine 0.375% plus lidocaine 1% with epinephrine (15 mL of ropivacaine 0.75% plus 15 mL of lidocaine 2% with epinephrine; final epinephrine concentration 2.5 micrograms/mL, 75 micrograms total), single perineural injection. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults of any sex aged 18 to 59 years.
- Scheduled for upper limb orthopedic or trauma surgery under brachial plexus block at Hospital General de Zona No. 3, IMSS, Aguascalientes.
- American Society of Anesthesiologists (ASA) physical status I to III.
- Signed informed consent.
Key exclusion criteria (6 listed)
- Allergy to ropivacaine, lidocaine or epinephrine.
- Emergency surgery.
- Uncooperative patients.
- Previous brachial plexus injury.
- Upper limb neuropathy.
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 |
|---|---|---|
| ropivacaineRopivacaine 112.5 mg (15 mL of 0.75%) administered perineurally in an ultrasound-guided supraclavicular brachial plexus block, diluted to a total volume of 30 mL. | Drug | Group C: Ropivacaine 0.375% |
| lidocaineLidocaine 300 mg (15 mL of 2%) mixed with ropivacaine for perineural administration in the supraclavicular brachial plexus block (final lidocaine concentration 1%). | Drug | Group L: Ropivacaine 0.375% + Lidocaine 1% |
| lidocaine with epinephrineLidocaine 300 mg with epinephrine 75 micrograms (15 mL of lidocaine 2% with epinephrine) mixed with ropivacaine for perineural administration (final concentrations: lidocaine 1%, epinephrine 2.5 micrograms/mL). | Drug | Group E: Ropivacaine 0.375% + Lidocaine 1% With Epinephrine |
Primary outcome
Postoperative Pain Intensity at 6 Hours
Time frame: 6 hours after the end of surgery
Pain intensity measured with the 11-point Numeric Rating Scale (NRS), from 0 (no pain) to 10 (worst imaginable pain), compared among the three groups.
6 secondary outcomes
Postoperative Pain Intensity at 0 and 12 Hours
Time frame: Immediately after the end of surgery (0 hours) and 12 hours after the end of surgery
Number of Participants Requiring Rescue Analgesia (Duration of Analgesia)
Time frame: At 0, 6 and 12 hours after the end of surgery
Rescue Analgesic Consumption by Drug Type
Time frame: Up to 12 hours after the end of surgery
Number of Participants Receiving Postoperative Opioids
Time frame: Up to 12 hours after the end of surgery
Upper Limb Motor Block (Modified Bromage Scale)
Time frame: At 0, 6 and 12 hours after the end of surgery
Number of Participants With Block-Related Adverse Events
Time frame: Up to 12 hours after the end of 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 30 Oct 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data underlying the results reported (baseline characteristics, pain scores, motor block, rescue analgesia and adverse events), together with the data dictionary, study protocol, statistical analysis plan, informed consent form and analytic code.
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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.
Cristina González Ramírez, MD, PhD principal investigator
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ropivacaine, lidocaine and lidocaine with epinephrine in people with Postoperative Pain and Upper Extremity Fracture, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 4 inclusion and 6 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 30 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 Mexico. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Postoperative Pain Intensity at 6 Hours (time frame: 6 hours after 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 30 Oct 2026.