Postoperative Pain ManagementLAPOFARNCT07307625
LAPOFAR Trial: Opioid-Free vs. Remifentanil Anesthesia in Laparoscopic Cholecystectomy
A study testing Lidocaine + Dexmedetomidine and Remifentanil in people with Postoperative Pain Management and Postoperative Nausea and Vomiting, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study was a single-center, prospective, randomized clinical trial designed to compare the effects of opioid-free anesthesia (OFA) with standard opioid-based anesthesia during elective laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain Management, Postoperative Nausea and Vomiting, Laparoscopic Cholecystectomy
- What is being tested?
- Lidocaine + Dexmedetomidine and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2024to 1 Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65
- ASA I-II
- Elective laparoscopic cholecystectomy
- Informed consent
- BMI 18-30 kg/m²
- Normal liver and renal function
Who cannot join
- Refusal to participate
- Allergy to study drugs
- Chronic opioid use
- Major organ disease
- Pregnancy or lactation
- Open surgery conversion
- Recent participation in another trial
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBÜ Kartal Dr. Lütfi Kırdar City Hospital
Istanbul
About this study
Official title: A Randomized Comparative Study of Opioid-Free Versus Opioid-Based Anesthesia in Laparoscopic Cholecystectomy Surgery
This study was a single-center, prospective, randomized clinical trial designed to compare the effects of opioid-free anesthesia (OFA) with standard opioid-based anesthesia during elective laparoscopic cholecystectomy. The aim was to evaluate the impact of these two anesthetic approaches on postoperative pain, analgesic requirement, hemodynamic stability, postoperative nausea and vomiting (PONV), and recovery quality.
A total of 101 patients, aged 18 to 65 years and classified as ASA I-II, undergoing elective laparoscopic cholecystectomy were enrolled and randomized into two groups. The OFA group received intravenous lidocaine and dexmedetomidine, while the standard anesthesia (RA) group received a remifentanil-based protocol. All other anesthetic agents and surgical procedures were standardized across both groups.
Read more
Intraoperative monitoring included heart rate, systolic and diastolic blood pressure, and end-tidal CO₂, recorded at 5-minute intervals. Postoperative assessments included visual analog scale (VAS) pain scores at multiple time points (10, 20, 30, 60 minutes; 2, 12, and 24 hours), rescue analgesic use, incidence of PONV, and Modified Aldrete Scores at 0, 30, and 60 minutes.
The results demonstrated that patients in the OFA group experienced significantly lower VAS pain scores in both early and late postoperative periods. The OFA group also required less rescue analgesia, had lower heart rate and blood pressure readings postoperatively, and showed a reduced incidence of PONV. Additionally, recovery parameters such as shorter time to extubation and higher early Aldrete scores favored the OFA group.
These findings suggest that opioid-free anesthesia using lidocaine and dexmedetomidine is a safe and effective alternative to opioid-based anesthesia in laparoscopic cholecystectomy. It provides better postoperative pain control, reduces opioid-related side effects, and improves overall recovery. The study supports the potential for integrating OFA into enhanced recovery protocols and calls for further multicenter trials with larger sample sizes to validate and generalize the results.
Read the detailed description
Postoperative pain remains a major clinical concern, affecting recovery, patient comfort, and hospital resource utilization. Traditionally, opioids have played a central role in intraoperative and postoperative pain management. However, opioid use is associated with several adverse effects such as respiratory depression, nausea, vomiting, sedation, ileus, tolerance, hyperalgesia, and dependency. These drawbacks have driven interest in alternative strategies that reduce or eliminate perioperative opioid exposure, particularly within the framework of Enhanced Recovery After Surgery (ERAS) protocols.
Opioid-Free Anesthesia (OFA) is a multimodal approach that omits opioids and instead utilizes a combination of non-opioid agents such as lidocaine, dexmedetomidine, ketamine, NSAIDs, and magnesium sulfate to provide analgesia, hemodynamic stability, and sedation. OFA aims to minimize opioid-related side effects while maintaining effective pain control and facilitating faster recovery.
This single-center, prospective, randomized controlled trial was designed to compare OFA using intravenous lidocaine and dexmedetomidine to standard general anesthesia with remifentanil in patients undergoing elective laparoscopic cholecystectomy. The primary aim was to assess the effect of OFA on postoperative pain scores and rescue analgesia requirement. Secondary outcomes included intraoperative hemodynamic parameters, postoperative nausea and vomiting (PONV), and recovery quality assessed via Modified Aldrete Scores.
A total of 101 adult patients, aged 18-65 years, classified as ASA I-II, were enrolled and randomized into two groups:
OFA Group: Received intravenous lidocaine (1.5 mg/kg bolus followed by infusion at 1.5 mg/kg/h) and dexmedetomidine (0.5 μg/kg loading dose followed by 0.5 μg/kg/h infusion).
RA Group (Remifentanil Group): Received standard anesthesia with remifentanil infusion (0.1-0.5 μg/kg/min), in combination with propofol and rocuronium.
Standard monitoring included non-invasive blood pressure, ECG, SpO₂, EtCO₂, and bispectral index (BIS). Intraoperative hemodynamic values (heart rate, systolic and diastolic blood pressure, EtCO₂) were recorded at 5-minute intervals. Postoperative pain was assessed using the Visual Analog Scale (VAS) at 10, 20, 30, and 60 minutes, and at 2, 12, and 24 hours. PONV incidence and the need for rescue antiemetics were also recorded. Recovery was evaluated using Modified Aldrete Scores at 0, 30, and 60 minutes post-extubation.
Statistical analysis was performed using R (v4.5.1). Normality was assessed via the Shapiro-Wilk test. Between-group comparisons used the independent t-test or Mann-Whitney U test for continuous variables and chi-square or Fisher's exact test for categorical data. Within-group comparisons of pre- and postoperative values used paired t-tests or Wilcoxon signed-rank tests as appropriate.
The study found that the OFA group had significantly lower postoperative VAS scores at all time points, reduced need for rescue analgesics, and lower incidence of PONV. Hemodynamic parameters such as heart rate and blood pressure were more stable intra- and postoperatively in the OFA group. Moreover, time to extubation was shorter and early recovery scores were higher among patients who received OFA.
These findings suggest that opioid-free anesthesia with lidocaine and dexmedetomidine provides superior outcomes in terms of postoperative pain control, recovery, and complication rates compared to opioid-based anesthesia with remifentanil. The results support the inclusion of OFA in clinical practice and ERAS protocols for laparoscopic cholecystectomy. Further multicenter studies with larger sample sizes and inclusion of different surgical procedures are warranted to generalize these findings.
- Conditions
- Postoperative Pain Management, Postoperative Nausea and Vomiting, Laparoscopic Cholecystectomy, Opioid-free Anesthesia, General Anesthesia
- Being tested
- Lidocaine + Dexmedetomidine, Remifentanil
- Keywords
- Dexmedetomidine, Lidocaine, Opioid-Free Anesthesia, Analgesic Requirement, Postoperative Pain
- Medical subject headings
- Postoperative Nausea and Vomiting, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine + DexmedetomidineDrug
Participants received intravenous lidocaine and dexmedetomidine as part of the opioid-free anesthesia protocol. Lidocaine was administered as a 1.5 mg/kg bolus followed by continuous infusion at 1.5 mg/kg/h. Dexmedetomidine was administered as a 0.5 µg/kg loading dose over 10 minutes, followed by continuous infusion at 0.5 µg/kg/h until the end of surgery. No intraoperative opioids were given.
RemifentanilDrug
Participants received standard opioid-based anesthesia with continuous intravenous remifentanil infusion at 0.1-0.5 µg/kg/min. Induction and maintenance of anesthesia were standardized with propofol and rocuronium. All other perioperative conditions were matched to the OFA group.
| Study group | Role | What they receive |
|---|---|---|
| Opioid-Free Anesthesia (OFA) | Experimental | Participants in this group received intravenous lidocaine and dexmedetomidine for opioid-free anesthesia. Lidocaine was administered as a 1.5 mg/kg bolus followed by a continuous infusion of 1.5 mg/kg/h. Dexmedetomidine was administered as a 0.5 µg/kg loading dose over 10 minutes, followed by an infusion of 0.5 µg/kg/h. No opioids were used intraoperatively. Standard induction with propofol and muscle relaxation with rocuronium were applied. Receives: Drug: Lidocaine + Dexmedetomidine |
| Opioid-Based Anesthesia (RA) | Active comparator | Participants in this group received standard general anesthesia with remifentanil infusion at 0.1-0.5 µg/kg/min. Anesthesia induction was performed using propofol and rocuronium. All other surgical and anesthetic parameters were standardized to match those of the OFA group. Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score (VAS)
VAS at multiple time points post-surgery
Measured: 0-24 hrs
Secondary outcomes (5)
Rescue Analgesic Use
Total mg of analgesics
Measured: 0-24 hrs
PONV Incidence
Presence of nausea/vomiting
Measured: 0-24 hrs
Hemodynamic Monitoring
HR, SBP, DBP every 5 min
Measured: Intraoperative
Recovery Score (Aldrete)
Modified Aldrete score
Measured: 0, 30, 60 min post-extubation
Extubation Time
Minutes to extubation
Measured: Immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start15 Dec 2024
- Primary completion1 Sep 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ManagementStudies 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
- Participants were randomly assigned to one of two parallel intervention groups. One group received opioid-free anesthesia (lidocaine and dexmedetomidine infusion), while the other received standard opioid-based anesthesia (remifentanil). Each participant remained in their assigned group throughout the procedure and follow-up period. The study used a 1:1 allocation ratio and compared outcomes such as postoperative pain, nausea and vomiting, and recovery parameters.
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gorkem Tukenmez, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307625
- Sponsor's protocol ID
- DrLutfiKirdarTRH-ANES-GT-01
- Other IDs
- 2024/010.99/10/31
- Acronym
- LAPOFAR
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared publicly due to local data privacy regulations and institutional policy. Aggregate results will be available in published form.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparative Study of Opioid-Free Versus Opioid-Based Anesthesia in Laparoscopic Cholecystectomy Surgery
- ClinicalTrials.gov ID
- NCT07307625
- Acronym / sponsor ID
- LAPOFAR / DrLutfiKirdarTRH-ANES-GT-01
- Conditions
- Postoperative Pain Management, Postoperative Nausea and Vomiting, Laparoscopic Cholecystectomy, Opioid-free Anesthesia, General Anesthesia
- Keywords
- Dexmedetomidine, Lidocaine, Opioid-Free Anesthesia, Analgesic Requirement, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 29 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 was a single-center, prospective, randomized clinical trial designed to compare the effects of opioid-free anesthesia (OFA) with standard opioid-based anesthesia during elective laparoscopic cholecystectomy. The aim was to evaluate the impact of these two anesthetic approaches on postoperative pain, analgesic requirement, hemodynamic stability, postoperative nausea and vomiting (PONV), and recovery quality.
A total of 101 patients, aged 18 to 65 years and classified as ASA I-II, undergoing elective laparoscopic cholecystectomy were enrolled and randomized into two groups. The OFA group received intravenous lidocaine and dexmedetomidine, while the standard anesthesia (RA) group received a remifentanil-based protocol. All other anesthetic agents and surgical procedures were standardized across both groups.
Intraoperative monitoring included heart rate, systolic and diastolic blood pressure, and end-tidal CO₂, recorded at 5-minute intervals. Postoperative assessments included visual analog scale (VAS) pain scores at multiple time points (10, 20, 30, 60 minutes; 2, 12, and 24 hours), rescue analgesic use, incidence of PONV, and Modified Aldrete Scores at 0, 30, and 60 minutes.
The results demonstrated that patients in the OFA group experienced significantly lower VAS pain scores in both early and late postoperative periods. The OFA group also required less rescue analgesia, had lower heart rate and blood pressure readings postoperatively, and showed a reduced incidence of PONV. Additionally, recovery parameters such as shorter time to extubation and higher early Aldrete scores favored the OFA group.
These findings suggest that opioid-free anesthesia using lidocaine and dexmedetomidine is a safe and effective alternative to opioid-based anesthesia in laparoscopic cholecystectomy. It provides better postoperative pain control, reduces opioid-related side effects, and improves overall recovery. The study supports the potential for integrating OFA into enhanced recovery protocols and calls for further multicenter trials with larger sample sizes to validate and generalize the results.
Detailed description
Postoperative pain remains a major clinical concern, affecting recovery, patient comfort, and hospital resource utilization. Traditionally, opioids have played a central role in intraoperative and postoperative pain management. However, opioid use is associated with several adverse effects such as respiratory depression, nausea, vomiting, sedation, ileus, tolerance, hyperalgesia, and dependency. These drawbacks have driven interest in alternative strategies that reduce or eliminate perioperative opioid exposure, particularly within the framework of Enhanced Recovery After Surgery (ERAS) protocols.
Opioid-Free Anesthesia (OFA) is a multimodal approach that omits opioids and instead utilizes a combination of non-opioid agents such as lidocaine, dexmedetomidine, ketamine, NSAIDs, and magnesium sulfate to provide analgesia, hemodynamic stability, and sedation. OFA aims to minimize opioid-related side effects while maintaining effective pain control and facilitating faster recovery.
This single-center, prospective, randomized controlled trial was designed to compare OFA using intravenous lidocaine and dexmedetomidine to standard general anesthesia with remifentanil in patients undergoing elective laparoscopic cholecystectomy. The primary aim was to assess the effect of OFA on postoperative pain scores and rescue analgesia requirement. Secondary outcomes included intraoperative hemodynamic parameters, postoperative nausea and vomiting (PONV), and recovery quality assessed via Modified Aldrete Scores.
A total of 101 adult patients, aged 18-65 years, classified as ASA I-II, were enrolled and randomized into two groups:
OFA Group: Received intravenous lidocaine (1.5 mg/kg bolus followed by infusion at 1.5 mg/kg/h) and dexmedetomidine (0.5 μg/kg loading dose followed by 0.5 μg/kg/h infusion).
RA Group (Remifentanil Group): Received standard anesthesia with remifentanil infusion (0.1-0.5 μg/kg/min), in combination with propofol and rocuronium.
Standard monitoring included non-invasive blood pressure, ECG, SpO₂, EtCO₂, and bispectral index (BIS). Intraoperative hemodynamic values (heart rate, systolic and diastolic blood pressure, EtCO₂) were recorded at 5-minute intervals. Postoperative pain was assessed using the Visual Analog Scale (VAS) at 10, 20, 30, and 60 minutes, and at 2, 12, and 24 hours. PONV incidence and the need for rescue antiemetics were also recorded. Recovery was evaluated using Modified Aldrete Scores at 0, 30, and 60 minutes post-extubation.
Statistical analysis was performed using R (v4.5.1). Normality was assessed via the Shapiro-Wilk test. Between-group comparisons used the independent t-test or Mann-Whitney U test for continuous variables and chi-square or Fisher's exact test for categorical data. Within-group comparisons of pre- and postoperative values used paired t-tests or Wilcoxon signed-rank tests as appropriate.
The study found that the OFA group had significantly lower postoperative VAS scores at all time points, reduced need for rescue analgesics, and lower incidence of PONV. Hemodynamic parameters such as heart rate and blood pressure were more stable intra- and postoperatively in the OFA group. Moreover, time to extubation was shorter and early recovery scores were higher among patients who received OFA.
These findings suggest that opioid-free anesthesia with lidocaine and dexmedetomidine provides superior outcomes in terms of postoperative pain control, recovery, and complication rates compared to opioid-based anesthesia with remifentanil. The results support the inclusion of OFA in clinical practice and ERAS protocols for laparoscopic cholecystectomy. Further multicenter studies with larger sample sizes and inclusion of different surgical procedures are warranted to generalize these findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel intervention groups. One group received opioid-free anesthesia (lidocaine and dexmedetomidine infusion), while the other received standard opioid-based anesthesia (remifentanil). Each participant remained in their assigned group throughout the procedure and follow-up period. The study used a 1:1 allocation ratio and compared outcomes such as postoperative pain, nausea and vomiting, and recovery parameters.
| Arm | Type | Receives |
|---|---|---|
| Opioid-Free Anesthesia (OFA) | Experimental | Drug: Lidocaine + DexmedetomidineParticipants in this group received intravenous lidocaine and dexmedetomidine for opioid-free anesthesia. Lidocaine was administered as a 1.5 mg/kg bolus followed by a continuous infusion of 1.5 mg/kg/h. Dexmedetomidine was administered as a 0.5 µg/kg loading dose over 10 minutes, followed by an infusion of 0.5 µg/kg/h. No opioids were used intraoperatively. Standard induction with propofol and muscle relaxation with rocuronium were applied. |
| Opioid-Based Anesthesia (RA) | Active comparator | Drug: RemifentanilParticipants in this group received standard general anesthesia with remifentanil infusion at 0.1-0.5 µg/kg/min. Anesthesia induction was performed using propofol and rocuronium. All other surgical and anesthetic parameters were standardized to match those of the OFA group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-65
- ASA I-II
- Elective laparoscopic cholecystectomy
- Informed consent
- BMI 18-30 kg/m²
Key exclusion criteria (7 listed)
- Refusal to participate
- Allergy to study drugs
- Chronic opioid use
- Major organ disease
- Pregnancy or lactation
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 |
|---|---|---|
| Lidocaine + DexmedetomidineParticipants received intravenous lidocaine and dexmedetomidine as part of the opioid-free anesthesia protocol. Lidocaine was administered as a 1.5 mg/kg bolus followed by continuous infusion at 1.5 mg/kg/h. Dexmedetomidine was administered as a 0.5 µg/kg loading dose over 10 minutes, followed by continuous infusion at 0.5 µg/kg/h until the end of surgery. No intraoperative opioids were given. | Drug | Opioid-Free Anesthesia (OFA) |
| RemifentanilParticipants received standard opioid-based anesthesia with continuous intravenous remifentanil infusion at 0.1-0.5 µg/kg/min. Induction and maintenance of anesthesia were standardized with propofol and rocuronium. All other perioperative conditions were matched to the OFA group. | Drug | Opioid-Based Anesthesia (RA) |
Primary outcome
Postoperative Pain Score (VAS)
Time frame: 0-24 hrs
VAS at multiple time points post-surgery
5 secondary outcomes
Rescue Analgesic Use
Time frame: 0-24 hrs
PONV Incidence
Time frame: 0-24 hrs
Hemodynamic Monitoring
Time frame: Intraoperative
Recovery Score (Aldrete)
Time frame: 0, 30, 60 min post-extubation
Extubation Time
Time frame: Immediately after 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 29 Dec 2025.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared publicly due to local data privacy regulations and institutional policy. Aggregate results will be available in published form.
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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 Lidocaine + Dexmedetomidine and Remifentanil in people with Postoperative Pain Management and Postoperative Nausea and Vomiting, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 6 inclusion and 7 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 29 Dec 2025. 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 Turkey (Türkiye). 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 Score (VAS) (time frame: 0-24 hrs). 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 29 Dec 2025.