Opioid-Free AnesthesiaOFANCT07306910
Effect of Opioid-Free Anesthesia (OFA) on Postoperative Pain and Perioperative Nausea and Vomiting in Elective Laparoscopic .
A study testing opoid free anesthesia in people with Opioid-Free Anesthesia and Elective Laparoscopic Cholecystectomy, run by Assiut University.
Trial summary
1. To evaluate the efficacy of a standardized multimodal Opioid Sparing (OS) protocol versus conventional opioid-based analgesia in reducing acute postoperative 2. To quantify opioid consumption reduction achievable through OS strategies 3. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid-Free Anesthesia, Elective Laparoscopic Cholecystectomy
- What is being tested?
- opoid free anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2025to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18 to 60 years scheduled for elective laparoscopic cholecystectomy. Elective must be included in title.
- ASA (American Society of Anesthesiologists) physical status I or II.
- Body Mass Index (BMI) < 35 kg/m².
Who cannot join
- Chronic opioid use (>30 MME/day for >3 months).
- Contraindications to study medications (e.g., severe hepatic impairment; allergy/contraindication to lidocaine, dexmedetomidine, ketamine, fentanyl, or NSAIDs).
- Renal dysfunction (eGFR <60 mL/min/1.73 m²).
- Significant cardiac conduction abnormalities.
- Pregnancy or lactation.
- Emergency surgery or conversion to open cholecystectomy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Opioid-Free Anesthesia (OFA) on Postoperative Pain and Perioperative Nausea and Vomiting in Elective Laparoscopic Cholecystectomy.
- To evaluate the efficacy of a standardized multimodal Opioid Sparing (OS) protocol versus conventional opioid-based analgesia in reducing acute postoperative
- To quantify opioid consumption reduction achievable through OS strategies
- To assess the impact of OS on hemodynamic parameters during critical surgical phases
- To compare recovery metrics (PONV, bowel function, ambulation)
- To evaluate the safety profile of OS anesthesia
Read the detailed description
The ongoing opioid crisis represents a significant public health challenge, with surgical prescriptions being a major contributor to chronic opioid use and misuse. Recent epidemiological data indicate that 4-6% of opioid- naïve patients develop persistent opioid use postoperatively, with laparoscopic cholecystectomy patients being particularly vulnerable due to moderate postoperative pain . Despite being a minimally invasive procedure, laparoscopic cholecystectomy consistently ranks among the most common general surgical procedures worldwide, with over 1 million performed annually in the United States alone. This frequency amplifies the population-level impact of postoperative prescribing patterns . Previous studies have demonstrated the efficacy of individual components-dexmedetomidine for hemodynamic stabilization, lidocaine infusions for visceral analgesia, and regional techniques like erector spinae plane (ESP) blocks-but their synergistic effects remain underexplored . A recent scoping review highlighted that while opioid-sparing (OS) effects are frequently reported, evidence for clinically meaningful outcomes (e.g., reduced ventilation time, accelerated functional recovery) remains limited . The pathophysiology of post-cholecystectomy pain involves both somatic (abdominal wall) and visceral (diaphragmatic irritation, biliary spasm) components, necessitating a multimodal approach. Opioids inadequately address inflammatory mediators while introducing risks of respiratory depression, postoperative nausea and vomiting (PONV), ileus, and hemodynamic instability. Emerging evidence suggests that α-2 agonists (e.g., dexmedetomidine) and NMDA ant
- Being tested
- opoid free anesthesia
- Keywords
- opa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opoid free anesthesiaOther
Also called Lidocaine, Dexmedetomidine, Magnesium
Maintenance Dexmedetomidine 0.2-0.5 µg/kg/h + Lidocaine 1.5 mg/kg/h + Magnesium 10 mg/kg/h; Sevoflurane as required; Atracurium 0.1 mg/kg IV PRN
| Study group | Role | What they receive |
|---|---|---|
| OpioidSparingGroup OS) | Active comparator | Not described Receives: Other: opoid free anesthesia |
| ControlGroup (CG) | Active comparator | Not described Receives: Other: opoid free anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity at rest postoperatively (Visual Analog Scale, VAS, 0-10)
Pain intensity at rest will be measured using the Visual Analog Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.
Measured: 48 hours post operative
Secondary outcomes (5)
Cumulative opioid use (MME)
Cumulative opioid consumption will be measured in morphine milligram equivalents (MME) administered to each patient.
Measured: 48 hours post operative
Time to extubating
Time to extubating; time to Aldrete ≥9
Measured: 24 hours post operative
Time to first rescue analgesia
time to first demand for rescue analgesia
Measured: 24 hours post operative
Bowel recovery (first flatus)
Time in hours from completion of surgery until the patient passes first flatus, representing bowel recovery.
Measured: 48 hours post operative
Ambulation tolerance
Assessment of the patient's ability to ambulate, measured as distance walked in feet or meters within specified postoperative periods.
Measured: 48 hours post operative
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 start30 Dec 2025 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Free AnesthesiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Type of the study: Prospective, triple-blind, parallel-group, superiority block randomized controlled trial. Study Setting and design features. • Allocation: Computer-generated 1:1 block randomization with allocation concealment (block size = 6), stratified by ASA status (I vs II/III).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Galal Eldeen Hasan Hasan Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306910
- Sponsor's protocol ID
- 211198
- Other IDs
- 211198
- Acronym
- OFA
- Status last verified
- Dec 2025
- First submitted
- 17 Oct 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- Effect of Opioid-Free Anesthesia (OFA) on Postoperative Pain and Perioperative Nausea and Vomiting in Elective Laparoscopic Cholecystectomy.
- ClinicalTrials.gov ID
- NCT07306910
- Acronym / sponsor ID
- OFA / 211198
- Keywords
- opa
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- 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.
- To evaluate the efficacy of a standardized multimodal Opioid Sparing (OS) protocol versus conventional opioid-based analgesia in reducing acute postoperative
- To quantify opioid consumption reduction achievable through OS strategies
- To assess the impact of OS on hemodynamic parameters during critical surgical phases
- To compare recovery metrics (PONV, bowel function, ambulation)
- To evaluate the safety profile of OS anesthesia
Detailed description
The ongoing opioid crisis represents a significant public health challenge, with surgical prescriptions being a major contributor to chronic opioid use and misuse. Recent epidemiological data indicate that 4-6% of opioid- naïve patients develop persistent opioid use postoperatively, with laparoscopic cholecystectomy patients being particularly vulnerable due to moderate postoperative pain . Despite being a minimally invasive procedure, laparoscopic cholecystectomy consistently ranks among the most common general surgical procedures worldwide, with over 1 million performed annually in the United States alone. This frequency amplifies the population-level impact of postoperative prescribing patterns . Previous studies have demonstrated the efficacy of individual components-dexmedetomidine for hemodynamic stabilization, lidocaine infusions for visceral analgesia, and regional techniques like erector spinae plane (ESP) blocks-but their synergistic effects remain underexplored . A recent scoping review highlighted that while opioid-sparing (OS) effects are frequently reported, evidence for clinically meaningful outcomes (e.g., reduced ventilation time, accelerated functional recovery) remains limited . The pathophysiology of post-cholecystectomy pain involves both somatic (abdominal wall) and visceral (diaphragmatic irritation, biliary spasm) components, necessitating a multimodal approach. Opioids inadequately address inflammatory mediators while introducing risks of respiratory depression, postoperative nausea and vomiting (PONV), ileus, and hemodynamic instability. Emerging evidence suggests that α-2 agonists (e.g., dexmedetomidine) and NMDA ant
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Type of the study: Prospective, triple-blind, parallel-group, superiority block randomized controlled trial. Study Setting and design features. • Allocation: Computer-generated 1:1 block randomization with allocation concealment (block size = 6), stratified by ASA status (I vs II/III).
| Arm | Type | Receives |
|---|---|---|
| OpioidSparingGroup OS) | Active comparator | Other: opoid free anesthesia |
| ControlGroup (CG) | Active comparator | Other: opoid free anesthesia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults aged 18 to 60 years scheduled for elective laparoscopic cholecystectomy. Elective must be included in title.
- ASA (American Society of Anesthesiologists) physical status I or II.
- Body Mass Index (BMI) < 35 kg/m².
Key exclusion criteria (6 listed)
- Chronic opioid use (>30 MME/day for >3 months).
- Contraindications to study medications (e.g., severe hepatic impairment; allergy/contraindication to lidocaine, dexmedetomidine, ketamine, fentanyl, or NSAIDs).
- Renal dysfunction (eGFR <60 mL/min/1.73 m²).
- Significant cardiac conduction abnormalities.
- 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 |
|---|---|---|
| opoid free anesthesiaAlso: Lidocaine, Dexmedetomidine, MagnesiumMaintenance Dexmedetomidine 0.2-0.5 µg/kg/h + Lidocaine 1.5 mg/kg/h + Magnesium 10 mg/kg/h; Sevoflurane as required; Atracurium 0.1 mg/kg IV PRN | Other | ControlGroup (CG), OpioidSparingGroup OS) |
Primary outcome
Pain intensity at rest postoperatively (Visual Analog Scale, VAS, 0-10)
Time frame: 48 hours post operative
Pain intensity at rest will be measured using the Visual Analog Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.
5 secondary outcomes
Cumulative opioid use (MME)
Time frame: 48 hours post operative
Time to extubating
Time frame: 24 hours post operative
Time to first rescue analgesia
Time frame: 24 hours post operative
Bowel recovery (first flatus)
Time frame: 48 hours post operative
Ambulation tolerance
Time frame: 48 hours post operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Aldrete, J. A. (1995). The post-anesthesia recovery score revisited. Journal of Clinical Anesthesia, \*7\*(1), 89-91.Link provided by the sponsor.
- .National Institutes of Health. HEAL Initiative: Preventing Opioid Use Disorder After Surgery. NIH Guide NOT-DA-22-052. 2022.Link provided by the sponsor.
- . Huskisson, E. C. (1974). Measurement of pain. The Lancet, \*304\*(7889), 1127-1131.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Opioid-Free Anesthesia
Not yet recruiting
Comparison of Intensive and Conservative NOL®-Guided Analgesia Strategies During Opioid-free Anesthesia
Anesthesia, Bariatric Surgery (Gastric Bypass)
Not yet recruiting
Effect of Opioid-free Anesthesia on Sleep Quality, Cognitive Function and Recovery Quality After General Anesthesia in Elderly Patients
Opioid-Free Anesthesia, POCD
Recruiting
Opioid-Free Versus Opioid-Based Anesthesia in Thyroid Surgery
Thyroidectomy, Oxidative Stress
Not yet recruiting
Intraoperative Infusion of Dexmedetomidine Versus Lidocaine or Magnesium Sulphate for Enhanced Quality of Recovery After Spine Surgery Fixation
Opioid Free Anesthesia, Opioid Based Anesthesia
Recruiting
Suprazygomatic Maxillary Nerve Block in Pediatric Tonsillectomy
Tonsillitis
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.
Questions about this trial
What is this clinical trial studying?
A study testing opoid free anesthesia in people with Opioid-Free Anesthesia and Elective Laparoscopic Cholecystectomy, run by Assiut University.
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 3 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: opening soon, 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ola Mahmoud Wahba Gnedy, Assistant Prof. (01151121981 ext. +2, ola.genadi@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity at rest postoperatively (Visual Analog Scale, VAS, 0-10) (time frame: 48 hours post operative). 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.