Postoperative PainNCT07500454
Analgesic Equivalence of NSAIDs and Tramadol in Acute Postoperative Pain Following Minimally Invasive Surgery
A study testing Tramadol, Ketorolac and Diclofenac in people with Postoperative Pain and Acute Pain, run by ISSSTE Hospital Regional "Gral. Ignacio Zaragoza" at 1 site in Mexico.
Trial summary
This pilot randomised controlled trial compared the analgesic equivalence of three intravenous premedication regimens - tramadol 150 mg, ketorolac 60 mg, and diclofenac 150 mg - in adult patients undergoing elective minimally invasive surgery under balanced general anaesthesia. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Postoperative Pain, Acute Pain
- What is being tested?
- Tramadol, Ketorolac and Diclofenac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 20 Jun 2024to 26 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-55 years
- ASA physical status I or II
- Body mass index 18.5-34.99 kg/m²
- Scheduled for elective minimally invasive surgery under balanced general anaesthesia
- Pre-surgical pain NRS = 0 and VRS = "absence" at baseline assessment
Who cannot join
- Pregnancy
- Known hypersensitivity to any study drug (tramadol, ketorolac, or diclofenac)
- Pre-existing acute pain with NRS ≥ 4 or VRS ≥ "moderate" before surgery
- Chronic pain with current analgesic use
- Withdrawal of consent before premedication administration
- Surgical duration exceeding 180 minutes
Show all 10Show fewer
- Conversion from laparoscopic to open surgical approach
- Hypersensitivity reaction during study drug administration
- Haemodynamic shock of any aetiology during the perioperative period
- Requirement for postoperative mechanical ventilation due to anaesthetic-surgical complications
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: Analgesic Equivalence of NSAIDs and a Weak Opioid in Acute Postoperative Pain Following Minimally Invasive Surgery Under Balanced General Anaesthesia: A Pilot Randomised Controlled Trial
This pilot randomised controlled trial compared the analgesic equivalence of three intravenous premedication regimens - tramadol 150 mg, ketorolac 60 mg, and diclofenac 150 mg - in adult patients undergoing elective minimally invasive surgery under balanced general anaesthesia. The primary outcome was postoperative pain intensity measured using the Numerical Rating Scale (NRS 0-10) at recovery room arrival and at 30, 60, and 90 minutes thereafter.
Read the detailed description
Acute postoperative pain remains inadequately managed in a substantial proportion of surgical patients, with particular challenges in resource-limited settings where access to potent opioids is restricted. Cross-class equianalgesic data comparing NSAIDs with weak opioids are scarce. This single-centre, double-blind, parallel-group pilot RCT was conducted at Hospital Regional "General Ignacio Zaragoza," ISSSTE, Mexico City. Thirty adult patients (ASA I-II, age 18-55 years, BMI 18.5-34.99 kg/m²) scheduled for elective laparoscopic surgery were randomised equally to receive tramadol 150 mg IV, ketorolac 60 mg IV, or diclofenac 150 mg IV, administered 45 minutes before skin incision. All patients received standardised balanced general anaesthesia. Pain was assessed using the NRS and Verbal Rating Scale (VRS) at five time points. Rescue analgesia (morphine 3 mg IV) was available on request. The trial was initially registered with the ISSSTE institutional research registry (RPI #403-2024).
- Conditions
- Postoperative Pain, Acute Pain
- Being tested
- Tramadol, Ketorolac, Diclofenac
- Keywords
- Postoperative pain, Acute pain, NSAIDs, Tramadol, Ketorolac, Diclofenac, Pilot, RTC
- Medical subject headings
- Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
Tramadol 150 mg IV, single dose, administered in 100 mL 0.9% saline 45 minutes before skin incision.
KetorolacDrug
Ketorolac 60 mg IV, single dose, administered in 100 mL 0.9% saline 45 minutes before skin incision.
DiclofenacDrug
Diclofenac 150 mg IV, single dose, administered in 100 mL 0.9% saline 45 minutes before skin incision.
| Study group | Role | What they receive |
|---|---|---|
| TRAM | Active comparator | Participants received tramadol 150 mg IV in 100 mL 0.9% saline, administered 45 minutes before skin incision as a single premedication dose, under double-blind conditions. Receives: Drug: Tramadol |
| KETO | Active comparator | Participants received ketorolac 60 mg IV in 100 mL 0.9% saline, administered 45 minutes before skin incision as a single premedication dose, under double-blind conditions. Receives: Drug: Ketorolac |
| DICLO | Active comparator | Participants received diclofenac 150 mg IV in 100 mL 0.9% saline, administered 45 minutes before skin incision as a single premedication dose, under double-blind conditions. Receives: Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity
Pain intensity assessed using the Numerical Rating Scale (NRS, 0-10; 0 = no pain, 10 = worst imaginable pain). Between-group comparisons performed at each time point using Kruskal-Wallis tests with Dunn post-hoc correction.
Measured: At recovery room arrival (Time_0), and at 30 (Time_1), 60 (Time_2), and 90 (Time_3) minutes after recovery room arrival.
Secondary outcomes (3)
Categorical pain intensity by Verbal Rating Scale (VRS)
Pain category assessed using a four-point Verbal Rating Scale (0 = absence, 1 = low, 2 = moderate, 3 = severe). Between-group differences assessed using Pearson's chi-squared test with Cramér's V as effect size.
Measured: At recovery room arrival (Time_0), and at 30 (Time_1), 60 (Time_2), and 90 (Time_3) minutes after recovery room arrival.
Rescue morphine consumption
Number of rescue analgesic doses and total morphine consumed (mg IV) per group. Rescue analgesia (morphine 3 mg IV) was administered on patient request or clinical indication.
Measured: At 30 (Time_1), 60 (Time_2), and 90 (Time_3) minutes after recovery room arrival.
Incidence of hypersensitivity reactions
Hypersensitivity reactions of any grade classified according to Müller criteria (Grade I-IV). Managed per institutional protocol (hydrocortisone 100 mg IV; adrenaline 0.5 mg IM for anaphylaxis).
Measured: Throughout the 90-minute observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start20 Jun 2024
- Primary completion23 Jul 2024
- Study completion26 Jul 2024
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm parallel-group pilot RCT. Participants were randomised equally (n=10 per group) to receive tramadol 150 mg IV, ketorolac 60 mg IV, or diclofenac 150 mg IV as premedication 45 minutes before skin incision.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 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
- NCT07500454
- Sponsor's protocol ID
- ISSSTE RPI #403-2024
- Status last verified
- Jul 2026
- First submitted
- 20 Mar 2026
- Last updated
- 10 Jul 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 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Equivalence of NSAIDs and a Weak Opioid in Acute Postoperative Pain Following Minimally Invasive Surgery Under Balanced General Anaesthesia: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07500454
- Acronym / sponsor ID
- ISSSTE RPI #403-2024
- Conditions
- Postoperative Pain, Acute Pain
- Keywords
- Postoperative pain, Acute pain, NSAIDs, Tramadol, Ketorolac, Diclofenac, Pilot, RTC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ISSSTE Hospital Regional "Gral. Ignacio Zaragoza"Other government
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 23 Jul 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 30 Mar 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 the analgesic equivalence of three intravenous premedication regimens - tramadol 150 mg, ketorolac 60 mg, and diclofenac 150 mg - in adult patients undergoing elective minimally invasive surgery under balanced general anaesthesia. The primary outcome was postoperative pain intensity measured using the Numerical Rating Scale (NRS 0-10) at recovery room arrival and at 30, 60, and 90 minutes thereafter.
Detailed description
Acute postoperative pain remains inadequately managed in a substantial proportion of surgical patients, with particular challenges in resource-limited settings where access to potent opioids is restricted. Cross-class equianalgesic data comparing NSAIDs with weak opioids are scarce. This single-centre, double-blind, parallel-group pilot RCT was conducted at Hospital Regional "General Ignacio Zaragoza," ISSSTE, Mexico City. Thirty adult patients (ASA I-II, age 18-55 years, BMI 18.5-34.99 kg/m²) scheduled for elective laparoscopic surgery were randomised equally to receive tramadol 150 mg IV, ketorolac 60 mg IV, or diclofenac 150 mg IV, administered 45 minutes before skin incision. All patients received standardised balanced general anaesthesia. Pain was assessed using the NRS and Verbal Rating Scale (VRS) at five time points. Rescue analgesia (morphine 3 mg IV) was available on request. The trial was initially registered with the ISSSTE institutional research registry (RPI #403-2024).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Three-arm parallel-group pilot RCT. Participants were randomised equally (n=10 per group) to receive tramadol 150 mg IV, ketorolac 60 mg IV, or diclofenac 150 mg IV as premedication 45 minutes before skin incision.
| Arm | Type | Receives |
|---|---|---|
| TRAM | Active comparator | Drug: TramadolParticipants received tramadol 150 mg IV in 100 mL 0.9% saline, administered 45 minutes before skin incision as a single premedication dose, under double-blind conditions. |
| KETO | Active comparator | Drug: KetorolacParticipants received ketorolac 60 mg IV in 100 mL 0.9% saline, administered 45 minutes before skin incision as a single premedication dose, under double-blind conditions. |
| DICLO | Active comparator | Drug: DiclofenacParticipants received diclofenac 150 mg IV in 100 mL 0.9% saline, administered 45 minutes before skin incision as a single premedication dose, under double-blind conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-55 years
- ASA physical status I or II
- Body mass index 18.5-34.99 kg/m²
- Scheduled for elective minimally invasive surgery under balanced general anaesthesia
- Pre-surgical pain NRS = 0 and VRS = "absence" at baseline assessment
Key exclusion criteria (10 listed)
- Pregnancy
- Known hypersensitivity to any study drug (tramadol, ketorolac, or diclofenac)
- Pre-existing acute pain with NRS ≥ 4 or VRS ≥ "moderate" before surgery
- Chronic pain with current analgesic use
- Withdrawal of consent before premedication administration
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 |
|---|---|---|
| TramadolTramadol 150 mg IV, single dose, administered in 100 mL 0.9% saline 45 minutes before skin incision. | Drug | TRAM |
| KetorolacKetorolac 60 mg IV, single dose, administered in 100 mL 0.9% saline 45 minutes before skin incision. | Drug | KETO |
| DiclofenacDiclofenac 150 mg IV, single dose, administered in 100 mL 0.9% saline 45 minutes before skin incision. | Drug | DICLO |
Primary outcome
Postoperative pain intensity
Time frame: At recovery room arrival (Time_0), and at 30 (Time_1), 60 (Time_2), and 90 (Time_3) minutes after recovery room arrival.
Pain intensity assessed using the Numerical Rating Scale (NRS, 0-10; 0 = no pain, 10 = worst imaginable pain). Between-group comparisons performed at each time point using Kruskal-Wallis tests with Dunn post-hoc correction.
3 secondary outcomes
Categorical pain intensity by Verbal Rating Scale (VRS)
Time frame: At recovery room arrival (Time_0), and at 30 (Time_1), 60 (Time_2), and 90 (Time_3) minutes after recovery room arrival.
Rescue morphine consumption
Time frame: At 30 (Time_1), 60 (Time_2), and 90 (Time_3) minutes after recovery room arrival.
Incidence of hypersensitivity reactions
Time frame: Throughout the 90-minute observation period
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 10 Jul 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 Tramadol, Ketorolac and Diclofenac in people with Postoperative Pain and Acute Pain, 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 10 Jul 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?
Postoperative pain intensity (time frame: At recovery room arrival (Time_0), and at 30 (Time_1), 60 (Time_2), and 90 (Time_3) minutes after recovery room 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 10 Jul 2026.