Acute Postoperative PainNCT07587645
Tapentadol vs Pregabalin for Postoperative Pain in Lower Limb Surgery
A study testing Tapentadol and Pregabalin in people with Acute Postoperative Pain and Lower Limb Surgery, run by ISSSTE Hospital Regional "Gral. Ignacio Zaragoza" at 1 site in Mexico.
Trial summary
This pilot randomised controlled trial compared 72-hour oral premedication with tapentadol (50 mg every 12 hours) versus pregabalin (75 mg every 24 hours) for preventing acute postoperative pain in 46 patients undergoing elective lower limb surgery under neuraxial anaesthesia. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Acute Postoperative Pain, Lower Limb Surgery
- What is being tested?
- Tapentadol and Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteMexico
- Study dates
- 19 Jun 2024to 5 Jul 2024
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-50 years
- ASA physical status I or II
- Body mass index between 18 and 35 kg/m²
- Scheduled for elective lower limb surgery under neuraxial anaesthesia
- Willing to provide written informed consent
Who cannot join
- Chronic use of analgesics or gabapentinoids
- Known hypersensitivity to tapentadol or pregabalin
- Pre-existing chronic pain
- Elimination Criteria:
- Hypersensitivity reaction to any study drug during administration
- Hemodynamic shock of any etiology
Show all 10Show fewer
- Requirement for advanced airway management or postoperative mechanical ventilation
- Surgical duration exceeding 120 minutes
- Requirement of an epidural catheter dose within the first two postoperative hours
- Voluntary withdrawal of consent at any point
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Regional "General Ignacio Zaragoza," ISSSTE
Mexico City, Mexico City, 09360
About this study
Official title: Oral Premedication With Tapentadol Versus Pregabalin for Acute Postoperative Pain in Lower Limb Surgery Under Neuraxial Anesthesia: A Pilot Randomized Controlled Trial
This pilot randomised controlled trial compared 72-hour oral premedication with tapentadol (50 mg every 12 hours) versus pregabalin (75 mg every 24 hours) for preventing acute postoperative pain in 46 patients undergoing elective lower limb surgery under neuraxial anaesthesia. The primary outcome was pain intensity measured by the Numeric Rating Scale (NRS 0-10) at PACU arrival and at 30, 60, 90, and 120 minutes thereafter. Secondary outcomes included Verbal Rating Scale scores, rescue morphine consumption, and safety (nausea/vomiting, hypersensitivity).
Read the detailed description
Acute postoperative pain affects over 80% of surgical patients, with orthopaedic lower limb procedures causing particularly severe pain. Preemptive analgesia may attenuate central sensitisation before surgical incision. Tapentadol (μ-opioid agonist + norepinephrine reuptake inhibitor) and pregabalin (voltage-gated calcium channel modulator) are pharmacologically distinct options, but direct comparative data are lacking.
This single-centre, double-blind, parallel-group pilot randomised controlled trial was conducted at Hospital Regional "General Ignacio Zaragoza," ISSSTE, Mexico City. Forty-six patients (ASA I-II, age 18-50 years, BMI 18-35 kg/m²) scheduled for elective lower limb surgery under neuraxial anaesthesia were randomised 1:1 to receive either tapentadol 50 mg orally every 12 hours (n=23) or pregabalin 75 mg orally every 24 hours (n=23), both initiated 72 hours before surgical incision.
The primary outcome was postoperative pain intensity assessed using the Numeric Rating Scale (NRS 0-10) at PACU arrival (T0) and at 30 (T1), 60 (T2), 90 (T3), and 120 (T4) minutes thereafter. Secondary outcomes included Verbal Rating Scale (VRS) scores, rescue morphine consumption (4 mg IV on request), and incidence of nausea/vomiting and hypersensitivity reactions. The primary longitudinal analysis used a linear mixed model with Group, Time, and Group×Time interaction as fixed effects and a random intercept per patient. Between-group contrasts at each timepoint were derived from estimated marginal means with Holm correction. Effect sizes are reported as Cohen's d.
The trial was approved by the institutional ethics and research committee (RPI #386-2024) and registered with the ISSSTE institutional research registry prior to enrolment. Due to institutional policy restrictions at the time of study initiation, registration on ClinicalTrials.gov was completed after data collection; this is disclosed transparently in accordance with CONSORT 2025 guidance on retrospective registration disclosure.
- Conditions
- Acute Postoperative Pain, Lower Limb Surgery
- Being tested
- Tapentadol, Pregabalin
- Keywords
- Tapentadol, Pregabalin, Preemptive analgesia, Acute postoperative pain, Lower limb surgery, Neuraxial anesthesia, Pilot randomized controlled trial
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TapentadolDrug
Tapentadol 50 mg immediate-release oral tablet administered every 12 hours for 72 hours preoperatively (total of 6 doses).
PregabalinDrug
Pregabalin 75 mg oral capsule administered every 24 hours for 72 hours preoperatively (total of 3 doses).
| Study group | Role | What they receive |
|---|---|---|
| Tapentadol | Experimental | Oral tapentadol 50 mg every 12 hours for 72 hours before surgical incision (total daily dose 100 mg). Receives: Drug: Tapentadol |
| Pregabalin | Active comparator | Oral pregabalin 75 mg every 24 hours for 72 hours before surgical incision (total daily dose 75 mg). Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity by Numeric Rating Scale (NRS)
Postoperative pain intensity measured using the Numeric Rating Scale (NRS, 0-10; 0 = no pain, 10 = worst imaginable pain). The primary longitudinal analysis used a linear mixed model with Group, Time, and Group×Time interaction as fixed effects and a random intercept per patient. Between-group contrasts at each timepoint were derived from estimated marginal means with Holm correction. Effect sizes reported as Cohen's d.
Measured: At PACU arrival (T0), 30 minutes (T1), 60 minutes (T2), 90 minutes (T3), and 120 minutes (T4) post-arrival
Secondary outcomes (4)
Verbal Rating Scale (VRS) pain category
Pain severity categorised as absence, low, moderate, or severe using the Verbal Rating Scale (VRS). Reported as proportions of patients in each category at each timepoint.
Measured: At PACU arrival (T0), 30 minutes (T1), 60 minutes (T2), 90 minutes (T3), and 120 minutes (T4) post-arrival
Rescue morphine consumption
Proportion of patients requiring rescue analgesia (morphine 4 mg IV) and total morphine consumption (mg) in each group.
Measured: During the two-hour PACU observation period (T0-T4)
Incidence of nausea and vomiting
Proportion of patients experiencing nausea and/or vomiting in each group, assessed by clinical observation and patient report.
Measured: During the two-hour PACU observation period (T0-T4)
Hypersensitivity reactions
Incidence of any hypersensitivity or anaphylactic reaction to tapentadol or pregabalin, classified according to Müller criteria.
Measured: From first dose of study medication through 24 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start19 Jun 2024
- Primary completion3 Jul 2024
- Study completion5 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel-group pilot RCT. Participants were randomised equally (n=23 per group) to receive 72-hour oral premedication with tapentadol (50 mg q12h) or pregabalin (75 mg q24h).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- ISSSTE Hospital Regional "Gral. Ignacio Zaragoza"
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mirna Magali Delgado Carlo, ISSSTE Hospital Regional "Gral. Ignacio Zaragoza"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587645
- Sponsor's protocol ID
- ISSSTE RPI #386-2024
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this article, along with the full analysis code, will be made available following article publication via the corresponding author's public GitHub repository (https://github.com/phabel-LD).
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Premedication With Tapentadol Versus Pregabalin for Acute Postoperative Pain in Lower Limb Surgery Under Neuraxial Anesthesia: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07587645
- Acronym / sponsor ID
- ISSSTE RPI #386-2024
- Conditions
- Acute Postoperative Pain, Lower Limb Surgery
- Keywords
- Tapentadol, Pregabalin, Preemptive analgesia, Acute postoperative pain, Lower limb surgery, Neuraxial anesthesia, Pilot randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- ISSSTE Hospital Regional "Gral. Ignacio Zaragoza"Other government
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 14 May 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 pilot randomised controlled trial compared 72-hour oral premedication with tapentadol (50 mg every 12 hours) versus pregabalin (75 mg every 24 hours) for preventing acute postoperative pain in 46 patients undergoing elective lower limb surgery under neuraxial anaesthesia. The primary outcome was pain intensity measured by the Numeric Rating Scale (NRS 0-10) at PACU arrival and at 30, 60, 90, and 120 minutes thereafter. Secondary outcomes included Verbal Rating Scale scores, rescue morphine consumption, and safety (nausea/vomiting, hypersensitivity).
Detailed description
Acute postoperative pain affects over 80% of surgical patients, with orthopaedic lower limb procedures causing particularly severe pain. Preemptive analgesia may attenuate central sensitisation before surgical incision. Tapentadol (μ-opioid agonist + norepinephrine reuptake inhibitor) and pregabalin (voltage-gated calcium channel modulator) are pharmacologically distinct options, but direct comparative data are lacking.
This single-centre, double-blind, parallel-group pilot randomised controlled trial was conducted at Hospital Regional "General Ignacio Zaragoza," ISSSTE, Mexico City. Forty-six patients (ASA I-II, age 18-50 years, BMI 18-35 kg/m²) scheduled for elective lower limb surgery under neuraxial anaesthesia were randomised 1:1 to receive either tapentadol 50 mg orally every 12 hours (n=23) or pregabalin 75 mg orally every 24 hours (n=23), both initiated 72 hours before surgical incision.
The primary outcome was postoperative pain intensity assessed using the Numeric Rating Scale (NRS 0-10) at PACU arrival (T0) and at 30 (T1), 60 (T2), 90 (T3), and 120 (T4) minutes thereafter. Secondary outcomes included Verbal Rating Scale (VRS) scores, rescue morphine consumption (4 mg IV on request), and incidence of nausea/vomiting and hypersensitivity reactions. The primary longitudinal analysis used a linear mixed model with Group, Time, and Group×Time interaction as fixed effects and a random intercept per patient. Between-group contrasts at each timepoint were derived from estimated marginal means with Holm correction. Effect sizes are reported as Cohen's d.
The trial was approved by the institutional ethics and research committee (RPI #386-2024) and registered with the ISSSTE institutional research registry prior to enrolment. Due to institutional policy restrictions at the time of study initiation, registration on ClinicalTrials.gov was completed after data collection; this is disclosed transparently in accordance with CONSORT 2025 guidance on retrospective registration disclosure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel-group pilot RCT. Participants were randomised equally (n=23 per group) to receive 72-hour oral premedication with tapentadol (50 mg q12h) or pregabalin (75 mg q24h).
| Arm | Type | Receives |
|---|---|---|
| Tapentadol | Experimental | Drug: TapentadolOral tapentadol 50 mg every 12 hours for 72 hours before surgical incision (total daily dose 100 mg). |
| Pregabalin | Active comparator | Drug: PregabalinOral pregabalin 75 mg every 24 hours for 72 hours before surgical incision (total daily dose 75 mg). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-50 years
- ASA physical status I or II
- Body mass index between 18 and 35 kg/m²
- Scheduled for elective lower limb surgery under neuraxial anaesthesia
- Willing to provide written informed consent
Key exclusion criteria (10 listed)
- Chronic use of analgesics or gabapentinoids
- Known hypersensitivity to tapentadol or pregabalin
- Pre-existing chronic pain
- Hypersensitivity reaction to any study drug during administration
- Hemodynamic shock of any etiology
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 |
|---|---|---|
| TapentadolTapentadol 50 mg immediate-release oral tablet administered every 12 hours for 72 hours preoperatively (total of 6 doses). | Drug | Tapentadol |
| PregabalinPregabalin 75 mg oral capsule administered every 24 hours for 72 hours preoperatively (total of 3 doses). | Drug | Pregabalin |
Primary outcome
Pain intensity by Numeric Rating Scale (NRS)
Time frame: At PACU arrival (T0), 30 minutes (T1), 60 minutes (T2), 90 minutes (T3), and 120 minutes (T4) post-arrival
Postoperative pain intensity measured using the Numeric Rating Scale (NRS, 0-10; 0 = no pain, 10 = worst imaginable pain). The primary longitudinal analysis used a linear mixed model with Group, Time, and Group×Time interaction as fixed effects and a random intercept per patient. Between-group contrasts at each timepoint were derived from estimated marginal means with Holm correction. Effect sizes reported as Cohen's d.
4 secondary outcomes
Verbal Rating Scale (VRS) pain category
Time frame: At PACU arrival (T0), 30 minutes (T1), 60 minutes (T2), 90 minutes (T3), and 120 minutes (T4) post-arrival
Rescue morphine consumption
Time frame: During the two-hour PACU observation period (T0-T4)
Incidence of nausea and vomiting
Time frame: During the two-hour PACU observation period (T0-T4)
Hypersensitivity reactions
Time frame: From first dose of study medication through 24 hours post-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 15 May 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in this article, along with the full analysis code, will be made available following article publication via the corresponding author's public GitHub repository (https://github.com/phabel-LD).
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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 Tapentadol and Pregabalin in people with Acute Postoperative Pain and Lower Limb Surgery, run by ISSSTE Hospital Regional "Gral. Ignacio Zaragoza" 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 5 inclusion and 10 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 15 May 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.
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?
Pain intensity by Numeric Rating Scale (NRS) (time frame: At PACU arrival (T0), 30 minutes (T1), 60 minutes (T2), 90 minutes (T3), and 120 minutes (T4) post-arrival). 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 15 May 2026.