Postoperative Pain IntensityNCT07787858
Effect of Opioid-Free Versus Opioid-Based Anesthesia in Discectomy Surgery
A study testing Dexmedetomidine and Ketamine-based Opioid-free Anesthesia and Fentanyl-based Opioid Anesthesia in people with Postoperative Pain Intensity, run by Zagazig University at 1 site in Egypt.
Trial summary
This prospective randomized double-blind clinical trial compares opioid-free anesthesia (OFA) versus opioid-based anesthesia (OBA) on postoperative analgesia in patients undergoing elective lumbar discectomy surgeries at Zagazig University Hospitals. Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Postoperative Pain Intensity
- What is being tested?
- Dexmedetomidine and Ketamine-based Opioid-free Anesthesia and Fentanyl-based Opioid Anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2026to 16 Jul 2026
- 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 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients' acceptance.
- Age : adult patients aged 21-64 years.
- Sex : both male and female.
- Physical state : Patients classified as American Society of Anesthesiologists (ASA) physical status I-II
- BMI : < 35 kg/ m2
- Patients scheduled for elective destectomy surgery under general anesthesia with an Expected duration of ≥ 3 hours.
Who cannot join
- Known allergy or contraindication to any study medications (e.g., dexmedetomidine, ketamine, lidocaine, opioids).
- History of chronic opioid use or opioid dependence.
- Psychiatric or neurological disorders interfering with pain assessment (e.g., cognitive impairment).
- Pregnancy or breastfeeding.
- Patients on medications that interact significantly with OBA agents (e.g., MAO inhibitors).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Opioid-Free Versus Opioid-Based Anesthesia on Postoperative Analgesia in Patients Undergoing Discectomy Surgery
This prospective randomized double-blind clinical trial compares opioid-free anesthesia (OFA) versus opioid-based anesthesia (OBA) on postoperative analgesia in patients undergoing elective lumbar discectomy surgeries at Zagazig University Hospitals. Forty-six adult patients (ASA I-II, aged 21-64) will be randomly allocated to two groups. Group F (OFA) receives dexmedetomidine (loading 1 µg/kg, infusion 0.2-0.7 µg/kg/hr) and ketamine (0.25-0.5 mg/kg, infusion 0.1-0.3 mg/kg/hr). Group B (OBA) receives fentanyl (2 µg/kg bolus, 1 µg/kg/hr infusion). Both groups receive propofol maintenance.
Primary outcome is postoperative pain intensity measured by Visual Analog Scale (0-10) at baseline, 2, 6, 12, and 24 hours. Secondary outcomes include total analgesic consumption in 24 hours, time to first rescue analgesia, intraoperative hemodynamic stability (BP, MAP, HR, RR), recovery time (to responsiveness), sedation depth (Modified Ramsay Score), PACU discharge time, patient satisfaction, and incidence of opioid-related adverse effects (nausea, vomiting, respiratory depression).
The study hypothesizes that OFA provides comparable analgesia with fewer opioid-related complications. As the first such study at Zagazig University, it addresses the critical need for effective non-opioid pain management in spine surgery, contributing to safer practices amid global opioid concerns.
Read the detailed description
Study Design and Methodology:
This is a single-center, prospective, randomized, double-blind, parallel-group, active-controlled clinical trial. A total of 46 adult patients scheduled for elective lumbar discectomy surgery under general anesthesia at Zagazig University Hospitals will be enrolled. Participants will be randomly assigned in a 1:1 ratio to one of two treatment arms using computer-generated randomization. The study will employ double-blinding where both participants and outcome assessors will be unaware of group assignments.
Intervention Protocols:
Opioid-free Anesthesia (OFA) Group: Patients will receive a multimodal non-opioid regimen consisting of: dexmedetomidine loading dose 1 µg/kg intravenous (IV) over 10 minutes before induction, followed by continuous infusion at 0.2-0.7 µg/kg/hr; ketamine 0.25-0.5 mg/kg IV at induction, followed by infusion at 0.1-0.3 mg/kg/hr; and propofol infusion (4-12 mg/kg/hr) for anesthesia maintenance.
Opioid-based Anesthesia (OBA) Group (Active Comparator): Patients will receive fentanyl 2 µg/kg IV at induction, followed by continuous infusion of 1 µg/kg/hr, along with propofol infusion (4-12 mg/kg/hr) for maintenance.
Both groups will receive standardized premedication (pantoprazole 40 mg, ondansetron 4 mg), antibiotic prophylaxis, neuromuscular blockade with atracurium, and reversal with neostigmine and atropine. Intraoperative ventilation parameters will be adjusted to maintain EtCO₂ between 35-40 mmHg.
Postoperative Management:
All patients will receive scheduled postoperative analgesia with paracetamol 1 g every 6 hours and intramuscular diclofenac 75 mg (maximum 150 mg/day). Rescue analgesia with IV nalbuphine (0.1-0.2 mg/kg, maximum 160 mg/day) will be administered for Visual Analog Scale (VAS) scores >3. Pain assessment will occur at baseline (immediate postoperative), 2, 6, 12, and 24 hours postoperatively.
Data Collection and Assessment:
Data will be collected preoperatively (demographics, medical history), intraoperatively (hemodynamic parameters, drug consumption), and postoperatively (pain scores, sedation levels, analgesic requirements, adverse events). Sedation will be assessed using the Modified Ramsay Sedation Score at 2-hour intervals for the first 12 hours, then every 4 hours for the next 12 hours. Hemodynamic stability will be monitored by recording blood pressure, mean arterial pressure, heart rate, and respiratory rate at predefined intervals.
Statistical Considerations:
Sample size calculation was based on detecting a difference in VAS scores between groups, with 80% power and 95% confidence level, yielding 42 patients plus 4 additional (10% dropout compensation), totaling 46 participants (23 per group). Data analysis will be performed using SPSS version 20.0, with appropriate statistical tests (t-tests, ANOVA, chi-square) and correction for multiple comparisons using Benjamini-Hochberg False Discovery Rate.
Ethical and Regulatory Aspects:
The study protocol has been submitted for approval to the Zagazig University Institutional Review Board (IRB). Written informed consent will be obtained from all participants. Patients retain the right to withdraw from the study at any time without affecting their medical care. The study will comply with Good Clinical Practice guidelines and the Declaration of Helsinki.
Study Duration and Timeline:
The total study duration is anticipated to be 6 months, including patient recruitment, intervention, follow-up, and data analysis. Results will be disseminated through academic publication and presentation.
- Conditions
- Postoperative Pain Intensity
- Being tested
- Dexmedetomidine and Ketamine-based Opioid-free Anesthesia, Fentanyl-based Opioid Anesthesia
- Keywords
- Opioid-free, Opioid-based, dexmedetomidine, Ketamine, fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine and Ketamine-based Opioid-free AnesthesiaCombination product
Also called OFA
Patients will receive: 1) Dexmedetomidine loading dose 1 µg/kg over 10 min, then infusion 0.2-0.7 µg/kg/hr; 2) Ketamine 0.25-0.5 mg/kg IV at induction, then infusion 0.1-0.3 mg/kg/hr; 3) Propofol infusion (4-12 mg/kg/hr) for anesthesia maintenance.
Fentanyl-based Opioid AnesthesiaDrug
Also called OBA
Patients will receive: 1) Fentanyl 2 µg/kg IV at induction, followed by continuous infusion of 1 µg/kg/hr; 2) Propofol infusion (4-12 mg/kg/hr) for anesthesia maintenance.
| Study group | Role | What they receive |
|---|---|---|
| Opioid-free Anesthesia | Experimental | Opioid-free anesthesia protocol using dexmedetomidine (loading 1 µg/kg, then 0.2-0.7 µg/kg/hr) and ketamine (0.25-0.5 mg/kg, then 0.1-0.3 mg/kg/hr) infusions alongside propofol for maintenance. Receives: Combination Product: Dexmedetomidine and Ketamine-based Opioid-free Anesthesia |
| Opioid-based Anesthesia | Active comparator | Standard opioid-based anesthesia using fentanyl (2 µg/kg bolus then 1 µg/kg/hr infusion) with propofol maintenance (4-12 mg/kg/hr). This is the traditional anesthetic technique against which the opioid-free approach is compared. Receives: Drug: Fentanyl-based Opioid Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity
Pain assessed using the Visual Analog Scale (VAS, 0-10)
Measured: 24 hours postoperatively (at baseline, 2, 6, 24 hours)
Secondary outcomes (7)
Intraoperative Mean arterial pressure (MAP)
Mean arterial pressure will be recorded during the intraoperative period using standard blood pressure monitoring.
Measured: Intraoperative period
Intraoperative Heart Rate (HR)
Heart rate will be recorded continuously during the intraoperative period.
Measured: Intraoperative period
Total postoperative analgesic consumption
The total amount of rescue analgesic administered during the first 24 hours postoperatively will be recorded.
Measured: First 24 hours postoperatively
Recovery time
Recovery time will be measured from the discontinuation of anesthesia until the patient achieves adequate recovery from anesthesia according to standard clinical criteria.
Measured: Perioperative period
Modified Ramsay Sedation Score
Depth of sedation will be assessed using the Modified Ramsay Sedation Score.
Measured: From immediately postoperatively through 24 hours postoperatively
Time to Discharge from Post-Anesthesia Care Unit (PACU)
Time from admission to the post-anesthesia care unit until the patient meets the criteria for discharge from the PACU.
Measured: From PACU admission until discharge from PACU
Overall Patient Satisfaction Score
Overall patient satisfaction with anesthesia and perioperative care will be assessed using a numerical rating scale.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start15 Jan 2026
- Primary completion16 Jul 2026
- Study completion16 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain IntensityStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mostafa Elsaid Mohamed Azab, Zagazig University
- Investigators
- Dr Asmaa Mohamed Galal Eldin, Assist Prof, Principal investigator, faculty of medicine zagazig university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787858
- Sponsor's protocol ID
- Zagazig-OFA-Discectomy
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available upon request after publication of the master's thesis. Researchers may contact the corresponding author for data access, subject to ethical approval and data sharing agreement.
Publications
Swamy AHM, Sneka G, Kumararadhya GB, Chennabasappa A, Shivakumar KG, Umesh S. Effects of Opioid-based and Opioid-free Anesthesia in Patients Undergoing Elective Laparoscopic Surgeries. Ann Afr Med. 2025 Apr 1;24(2):317-323. doi: 10.4103/aam.aam_137_24. Epub 2025 Feb 27.
PubMed 40019119Segebarth PB, Schallmo M, Odum S, Hietpas K, Michalek C, Chapman TM Jr, Leas D, Milam RA, Hamid N; CORE Research Group. Opioid-Free Analgesia is Safe and Effective in Anterior Cervical Spine Surgery: A Randomized Controlled Trial. Clin Spine Surg. 2024 May 1;37(4):138-148. doi: 10.1097/BSD.0000000000001608. Epub 2024 Mar 28.
PubMed 38553433Rani US, Panda NB, Chauhan R, Mahajan S, Kaloria N, Tripathi M. Comparison of the effects of opioid-free anesthesia (OFA) and opioid-based anesthesia (OBA) on postoperative analgesia and intraoperative hemodynamics in patients undergoing spine surgery: A prospective randomized double-blind controlled trial. Saudi J Anaesth. 2024 Apr-Jun;18(2):173-180. doi: 10.4103/sja.sja_341_23. Epub 2024 Mar 14.
PubMed 38654849Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.
PubMed 4835444Mathew DM, Fusco PJ, Varghese KS, Awad AK, Vega E, Mathew SM, Polizzi M, George J, Mathew CS, Thomas JJ, Calixte R, Ahmed A. Opioid-free anesthesia versus opioid-based anesthesia in patients undergoing cardiovascular and thoracic surgery: a meta-analysis and systematic review. Semin Cardiothorac Vasc Anesth. 2023 Sep;27(3):162-170. doi: 10.1177/10892532231180227. Epub 2023 Jun 10.
PubMed 37300532Mahdy, E. W., Mohammed, E. A., & Abdelwahab, Z. M. (2024). Comparative Study between Opioid-Free Anesthesia and Opioid-Based Anesthesia in Obese Patients Undergoing Abdominal Laparoscopic Surgery? Effective and Safe Analgesia Challenge: A Randomized Double Blinded Study. Egyptian Journal of Hospital Medicine, 97(1): 4261-7.
Kalagara R, Bhoi D, Subramaniam R, Baidya DK, Maitra S, Talawar P. Comparison between opioid-based anaesthesia technique and opioid-free anaesthesia technique in patients undergoing laparotomy for gynaecological malignancy: A randomised controlled trial. Indian J Anaesth. 2025 Mar;69(3):261-267. doi: 10.4103/ija.ija_151_24. Epub 2025 Feb 17.
PubMed 40161920Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.
PubMed 3785962Elahwal, L., Elmazny, M., & Elrahwan, S. M. (2023). The perioperative analgesic effect of opioid free anesthesia using combination of dexmedetomidine, ketamine and lidocaine in adolescent patients undergoing Scoliosis Surgery; A randomized Controlled Trial. Egyptian Journal of Anaesthesia, 39(1): 650-6.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Opioid-Free Versus Opioid-Based Anesthesia on Postoperative Analgesia in Patients Undergoing Discectomy Surgery
- ClinicalTrials.gov ID
- NCT07787858
- Acronym / sponsor ID
- Zagazig-OFA-Discectomy
- Conditions
- Postoperative Pain Intensity
- Keywords
- Opioid-free, Opioid-based, dexmedetomidine, Ketamine, fentanyl
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 16 Jul 2026 (actual)
- Study completion
- 16 Jul 2026 (actual)
- First posted
- 26 Aug 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 prospective randomized double-blind clinical trial compares opioid-free anesthesia (OFA) versus opioid-based anesthesia (OBA) on postoperative analgesia in patients undergoing elective lumbar discectomy surgeries at Zagazig University Hospitals. Forty-six adult patients (ASA I-II, aged 21-64) will be randomly allocated to two groups. Group F (OFA) receives dexmedetomidine (loading 1 µg/kg, infusion 0.2-0.7 µg/kg/hr) and ketamine (0.25-0.5 mg/kg, infusion 0.1-0.3 mg/kg/hr). Group B (OBA) receives fentanyl (2 µg/kg bolus, 1 µg/kg/hr infusion). Both groups receive propofol maintenance.
Primary outcome is postoperative pain intensity measured by Visual Analog Scale (0-10) at baseline, 2, 6, 12, and 24 hours. Secondary outcomes include total analgesic consumption in 24 hours, time to first rescue analgesia, intraoperative hemodynamic stability (BP, MAP, HR, RR), recovery time (to responsiveness), sedation depth (Modified Ramsay Score), PACU discharge time, patient satisfaction, and incidence of opioid-related adverse effects (nausea, vomiting, respiratory depression).
The study hypothesizes that OFA provides comparable analgesia with fewer opioid-related complications. As the first such study at Zagazig University, it addresses the critical need for effective non-opioid pain management in spine surgery, contributing to safer practices amid global opioid concerns.
Detailed description
Study Design and Methodology:
This is a single-center, prospective, randomized, double-blind, parallel-group, active-controlled clinical trial. A total of 46 adult patients scheduled for elective lumbar discectomy surgery under general anesthesia at Zagazig University Hospitals will be enrolled. Participants will be randomly assigned in a 1:1 ratio to one of two treatment arms using computer-generated randomization. The study will employ double-blinding where both participants and outcome assessors will be unaware of group assignments.
Intervention Protocols:
Opioid-free Anesthesia (OFA) Group: Patients will receive a multimodal non-opioid regimen consisting of: dexmedetomidine loading dose 1 µg/kg intravenous (IV) over 10 minutes before induction, followed by continuous infusion at 0.2-0.7 µg/kg/hr; ketamine 0.25-0.5 mg/kg IV at induction, followed by infusion at 0.1-0.3 mg/kg/hr; and propofol infusion (4-12 mg/kg/hr) for anesthesia maintenance.
Opioid-based Anesthesia (OBA) Group (Active Comparator): Patients will receive fentanyl 2 µg/kg IV at induction, followed by continuous infusion of 1 µg/kg/hr, along with propofol infusion (4-12 mg/kg/hr) for maintenance.
Both groups will receive standardized premedication (pantoprazole 40 mg, ondansetron 4 mg), antibiotic prophylaxis, neuromuscular blockade with atracurium, and reversal with neostigmine and atropine. Intraoperative ventilation parameters will be adjusted to maintain EtCO₂ between 35-40 mmHg.
Postoperative Management:
All patients will receive scheduled postoperative analgesia with paracetamol 1 g every 6 hours and intramuscular diclofenac 75 mg (maximum 150 mg/day). Rescue analgesia with IV nalbuphine (0.1-0.2 mg/kg, maximum 160 mg/day) will be administered for Visual Analog Scale (VAS) scores >3. Pain assessment will occur at baseline (immediate postoperative), 2, 6, 12, and 24 hours postoperatively.
Data Collection and Assessment:
Data will be collected preoperatively (demographics, medical history), intraoperatively (hemodynamic parameters, drug consumption), and postoperatively (pain scores, sedation levels, analgesic requirements, adverse events). Sedation will be assessed using the Modified Ramsay Sedation Score at 2-hour intervals for the first 12 hours, then every 4 hours for the next 12 hours. Hemodynamic stability will be monitored by recording blood pressure, mean arterial pressure, heart rate, and respiratory rate at predefined intervals.
Statistical Considerations:
Sample size calculation was based on detecting a difference in VAS scores between groups, with 80% power and 95% confidence level, yielding 42 patients plus 4 additional (10% dropout compensation), totaling 46 participants (23 per group). Data analysis will be performed using SPSS version 20.0, with appropriate statistical tests (t-tests, ANOVA, chi-square) and correction for multiple comparisons using Benjamini-Hochberg False Discovery Rate.
Ethical and Regulatory Aspects:
The study protocol has been submitted for approval to the Zagazig University Institutional Review Board (IRB). Written informed consent will be obtained from all participants. Patients retain the right to withdraw from the study at any time without affecting their medical care. The study will comply with Good Clinical Practice guidelines and the Declaration of Helsinki.
Study Duration and Timeline:
The total study duration is anticipated to be 6 months, including patient recruitment, intervention, follow-up, and data analysis. Results will be disseminated through academic publication and presentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid-free Anesthesia | Experimental | Combination Product: Dexmedetomidine and Ketamine-based Opioid-free AnesthesiaOpioid-free anesthesia protocol using dexmedetomidine (loading 1 µg/kg, then 0.2-0.7 µg/kg/hr) and ketamine (0.25-0.5 mg/kg, then 0.1-0.3 mg/kg/hr) infusions alongside propofol for maintenance. |
| Opioid-based Anesthesia | Active comparator | Drug: Fentanyl-based Opioid AnesthesiaStandard opioid-based anesthesia using fentanyl (2 µg/kg bolus then 1 µg/kg/hr infusion) with propofol maintenance (4-12 mg/kg/hr). This is the traditional anesthetic technique against which the opioid-free approach is compared. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients' acceptance.
- Age : adult patients aged 21-64 years.
- Sex : both male and female.
- Physical state : Patients classified as American Society of Anesthesiologists (ASA) physical status I-II
- BMI : < 35 kg/ m2
Key exclusion criteria (5 listed)
- Known allergy or contraindication to any study medications (e.g., dexmedetomidine, ketamine, lidocaine, opioids).
- History of chronic opioid use or opioid dependence.
- Psychiatric or neurological disorders interfering with pain assessment (e.g., cognitive impairment).
- Pregnancy or breastfeeding.
- Patients on medications that interact significantly with OBA agents (e.g., MAO inhibitors).
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 |
|---|---|---|
| Dexmedetomidine and Ketamine-based Opioid-free AnesthesiaAlso: OFAPatients will receive: 1) Dexmedetomidine loading dose 1 µg/kg over 10 min, then infusion 0.2-0.7 µg/kg/hr; 2) Ketamine 0.25-0.5 mg/kg IV at induction, then infusion 0.1-0.3 mg/kg/hr; 3) Propofol infusion (4-12 mg/kg/hr) for anesthesia maintenance. | Combination product | Opioid-free Anesthesia |
| Fentanyl-based Opioid AnesthesiaAlso: OBAPatients will receive: 1) Fentanyl 2 µg/kg IV at induction, followed by continuous infusion of 1 µg/kg/hr; 2) Propofol infusion (4-12 mg/kg/hr) for anesthesia maintenance. | Drug | Opioid-based Anesthesia |
Primary outcome
Postoperative pain intensity
Time frame: 24 hours postoperatively (at baseline, 2, 6, 24 hours)
Pain assessed using the Visual Analog Scale (VAS, 0-10)
7 secondary outcomes
Intraoperative Mean arterial pressure (MAP)
Time frame: Intraoperative period
Intraoperative Heart Rate (HR)
Time frame: Intraoperative period
Total postoperative analgesic consumption
Time frame: First 24 hours postoperatively
Recovery time
Time frame: Perioperative period
Modified Ramsay Sedation Score
Time frame: From immediately postoperatively through 24 hours postoperatively
Time to Discharge from Post-Anesthesia Care Unit (PACU)
Time frame: From PACU admission until discharge from PACU
Overall Patient Satisfaction Score
Time frame: 24 hours postoperatively
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 26 Aug 2026.
- Background: PubMed 40019119Swamy AHM, Sneka G, Kumararadhya GB, Chennabasappa A, Shivakumar KG, Umesh S. Effects of Opioid-based and Opioid-free Anesthesia in Patients Undergoing Elective Laparoscopic Surgeries. Ann Afr Med. 2025 Apr 1;24(2):317-323. doi: 10.4103/aam.aam_137_24. Epub 2025 Feb 27.
- Background: PubMed 38553433Segebarth PB, Schallmo M, Odum S, Hietpas K, Michalek C, Chapman TM Jr, Leas D, Milam RA, Hamid N; CORE Research Group. Opioid-Free Analgesia is Safe and Effective in Anterior Cervical Spine Surgery: A Randomized Controlled Trial. Clin Spine Surg. 2024 May 1;37(4):138-148. doi: 10.1097/BSD.0000000000001608. Epub 2024 Mar 28.
- Background: PubMed 38654849Rani US, Panda NB, Chauhan R, Mahajan S, Kaloria N, Tripathi M. Comparison of the effects of opioid-free anesthesia (OFA) and opioid-based anesthesia (OBA) on postoperative analgesia and intraoperative hemodynamics in patients undergoing spine surgery: A prospective randomized double-blind controlled trial. Saudi J Anaesth. 2024 Apr-Jun;18(2):173-180. doi: 10.4103/sja.sja_341_23. Epub 2024 Mar 14.
- Background: PubMed 4835444Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.
- Background: PubMed 37300532Mathew DM, Fusco PJ, Varghese KS, Awad AK, Vega E, Mathew SM, Polizzi M, George J, Mathew CS, Thomas JJ, Calixte R, Ahmed A. Opioid-free anesthesia versus opioid-based anesthesia in patients undergoing cardiovascular and thoracic surgery: a meta-analysis and systematic review. Semin Cardiothorac Vasc Anesth. 2023 Sep;27(3):162-170. doi: 10.1177/10892532231180227. Epub 2023 Jun 10.
- BackgroundMahdy, E. W., Mohammed, E. A., & Abdelwahab, Z. M. (2024). Comparative Study between Opioid-Free Anesthesia and Opioid-Based Anesthesia in Obese Patients Undergoing Abdominal Laparoscopic Surgery? Effective and Safe Analgesia Challenge: A Randomized Double Blinded Study. Egyptian Journal of Hospital Medicine, 97(1): 4261-7.
- Background: PubMed 40161920Kalagara R, Bhoi D, Subramaniam R, Baidya DK, Maitra S, Talawar P. Comparison between opioid-based anaesthesia technique and opioid-free anaesthesia technique in patients undergoing laparotomy for gynaecological malignancy: A randomised controlled trial. Indian J Anaesth. 2025 Mar;69(3):261-267. doi: 10.4103/ija.ija_151_24. Epub 2025 Feb 17.
- Background: PubMed 3785962Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.
- BackgroundElahwal, L., Elmazny, M., & Elrahwan, S. M. (2023). The perioperative analgesic effect of opioid free anesthesia using combination of dexmedetomidine, ketamine and lidocaine in adolescent patients undergoing Scoliosis Surgery; A randomized Controlled Trial. Egyptian Journal of Anaesthesia, 39(1): 650-6.
- Individual participant dataSharing planned: Yes. Individual participant data will be available upon request after publication of the master's thesis. Researchers may contact the corresponding author for data access, subject to ethical approval and data sharing agreement.
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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.
Dr Asmaa Mohamed Galal Eldin, Assist Prof principal investigator
faculty of medicine zagazig university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Ketamine-based Opioid-free Anesthesia and Fentanyl-based Opioid Anesthesia in people with Postoperative Pain Intensity, run by Zagazig University at 1 site in Egypt.
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 5 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 26 Aug 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 Egypt. 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: 24 hours postoperatively (at baseline, 2, 6, 24 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07787858, which also lists 9 linked publications.
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 26 Aug 2026.