AnesthesiaNCT07114237
The Effect of Opioid Free Anesthesia Using Ultrasound-Guided Bilateral Transversus Abdominus Plane Block and Dexmedetomidine Infusion
A study testing Opioid Free Anesthesia in people with Anesthesia and Opioid, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to determine the effects of Opioid-free anesthesia using dexmedetomidine and bilateral Transversus abdominis plane block on the quality of recovery, incidence of Opioid-free anesthesia, and post-operative pain and delirium in morbid obese patients undergoing gynecological surgeries. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Anesthesia, Opioid, Gynecological Surgery
- What is being tested?
- Opioid Free Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2025to 30 Dec 2026
- 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 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 female patients aged 21-65 years.
- Patients with a Body mass index≥ 35 kg/m2
- American society of Anesthesiology class II-III.
- Undergoing elective gynecological surgeries.
Who cannot join
- Patient refusal.
- History of allergy to local anesthetic.
- Liver or renal pathology affecting drug elimination.
- Mental dysfunction or cognitive disorders.
- Patients on chronic pain medications.
- Hypotension, bradycardia, atrioventricular block, intraventricular or sinoatrial block.
- Coagulopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Tanta University
Tanta
Merihan Ahmed, Resident, +20 11 11246871, mere4444.ma@gmail.com
About this study
Official title: The Effect of Opioid Free Anesthesia in Morbid Obese Patient Undergoing Gynecological Surgeries Using Ultrasound-Guided Bilateral Transversus Abdominus Plane Block and Dexmedetomidine Infusion: A Randomized Controlled
This study aimed to determine the effects of Opioid-free anesthesia using dexmedetomidine and bilateral Transversus abdominis plane block on the quality of recovery, incidence of Opioid-free anesthesia, and post-operative pain and delirium in morbid obese patients undergoing gynecological surgeries.
Read the detailed description
Opioid analgesic drugs have been the most commonly used perioperative pain-relieving medications for a very long time. While they are effective at relieving somatic pain they, unfortunately, do not eliminate neuropathic pain and have a profound potential for developing addiction.
The most significant opioid side effect is respiratory depression. This is especially important in patients with obesity, sleep apnea, chronic obstructive pulmonary disease and operations that are associated with a high incidence of post-operative respiratory failure.
Opioid may also induce post-operative nausea and vomiting , pruritus, urine retention, postoperative delirium. Furthermore, opioids depress cell mediated immunity and, in some studies, opioids have been found to be associated with an increased tumor recurrence rate after cancer surgery.
Opioid-free anesthesia has become more and more popular among anesthesiologists around the world. It is an emerging technique and a recent research perspective based on the idea that avoiding intraoperative opioids would be associated with better postoperative outcomes. It allows opioid-sparing and better outcomes than morphine administered as a sole analgesic agent after surgery. Opioid-free anesthesia is based on the same concept, as one drug will not replace opioids. It is the association of drugs and/or techniques that allows a good quality general anesthesia with no need for opioids. Dexmedetomidine is an alpha-2 agonist with analgesic action. Unlike opioids it is not associated with significant respiratory depression, post-operative nausea and vomiting, pruritus, constipation, ileus or delirium.
In laparoscopic surgeries, it has been found to provide adequate analgesia when used as the only analgesic. It provides enhanced recovery and patient satisfaction after laparotomy and should be considered as part of any enhanced recovery after surgery program.
Transversus abdominis plane block is a regional anesthesia technique that involves injecting a local anesthetic into the transversus abdominis plane. It is a triangular fascial plane located between the internal oblique (IO) and the transversus abdominis muscles.
This study aimed to determine the effects of Opioid-free anesthesia using dexmedetomidine and bilateral Transversus abdominis plane block on the quality of recovery, incidence of Opioid-free anesthesia, and post-operative pain and delirium in morbid obese patients undergoing gynecological surgeries.
- Conditions
- Anesthesia, Opioid, Gynecological Surgery
- Being tested
- Opioid Free Anesthesia, Control group (general anesthesia)
- Keywords
- Gynecological Surgeries, Opioid Free Anesthesia, Morbid Obese, Dexmedetomidine Infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Free AnesthesiaProcedure or surgery
patients will receive opioid free anesthesia and bilateral ultrasound guided transversus abdominus plane block.
Control group (general anesthesia)Procedure or surgery
patients will receive conventional general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group I: Opioid Free Anesthesia group | Experimental | patients will receive opioid free anesthesia and bilateral ultrasound guided transversus abdominus plane block Receives: Procedure: Opioid Free Anesthesia |
| Group II: Control group | Placebo comparator | patients will receive conventional general anesthesia Receives: Procedure: Control group (general anesthesia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of recovery on postoperative day
The Quality of Recovery-40 questionnaire scores. The Quality of Recovery-40 questionnaire includes five dimensions of recovery: physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items).
Measured: one day
Secondary outcomes (1)
Postoperative pain severity
Postoperative pain severity will be assessed by the numerical rating scale ( 0 no pain while 10 is the maximum pain).
Measured: 24 HOURS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start30 Aug 2025 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merihan Alaa Eldin Ahmed, Tanta University
- Investigators
- Merihan Ahmed, Resident, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114237
- Sponsor's protocol ID
- 36264MS694/9/24
- Status last verified
- May 2025
- First submitted
- 4 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Opioid Free Anesthesia in Morbid Obese Patient Undergoing Gynecological Surgeries Using Ultrasound-Guided Bilateral Transversus Abdominus Plane Block and Dexmedetomidine Infusion: A Randomized Controlled
- ClinicalTrials.gov ID
- NCT07114237
- Acronym / sponsor ID
- 36264MS694/9/24
- Conditions
- Anesthesia, Opioid, Gynecological Surgery
- Keywords
- Gynecological Surgeries, Opioid Free Anesthesia, Morbid Obese, Dexmedetomidine Infusion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Aug 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 aimed to determine the effects of Opioid-free anesthesia using dexmedetomidine and bilateral Transversus abdominis plane block on the quality of recovery, incidence of Opioid-free anesthesia, and post-operative pain and delirium in morbid obese patients undergoing gynecological surgeries.
Detailed description
Opioid analgesic drugs have been the most commonly used perioperative pain-relieving medications for a very long time. While they are effective at relieving somatic pain they, unfortunately, do not eliminate neuropathic pain and have a profound potential for developing addiction.
The most significant opioid side effect is respiratory depression. This is especially important in patients with obesity, sleep apnea, chronic obstructive pulmonary disease and operations that are associated with a high incidence of post-operative respiratory failure.
Opioid may also induce post-operative nausea and vomiting , pruritus, urine retention, postoperative delirium. Furthermore, opioids depress cell mediated immunity and, in some studies, opioids have been found to be associated with an increased tumor recurrence rate after cancer surgery.
Opioid-free anesthesia has become more and more popular among anesthesiologists around the world. It is an emerging technique and a recent research perspective based on the idea that avoiding intraoperative opioids would be associated with better postoperative outcomes. It allows opioid-sparing and better outcomes than morphine administered as a sole analgesic agent after surgery. Opioid-free anesthesia is based on the same concept, as one drug will not replace opioids. It is the association of drugs and/or techniques that allows a good quality general anesthesia with no need for opioids. Dexmedetomidine is an alpha-2 agonist with analgesic action. Unlike opioids it is not associated with significant respiratory depression, post-operative nausea and vomiting, pruritus, constipation, ileus or delirium.
In laparoscopic surgeries, it has been found to provide adequate analgesia when used as the only analgesic. It provides enhanced recovery and patient satisfaction after laparotomy and should be considered as part of any enhanced recovery after surgery program.
Transversus abdominis plane block is a regional anesthesia technique that involves injecting a local anesthetic into the transversus abdominis plane. It is a triangular fascial plane located between the internal oblique (IO) and the transversus abdominis muscles.
This study aimed to determine the effects of Opioid-free anesthesia using dexmedetomidine and bilateral Transversus abdominis plane block on the quality of recovery, incidence of Opioid-free anesthesia, and post-operative pain and delirium in morbid obese patients undergoing gynecological surgeries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I: Opioid Free Anesthesia group | Experimental | Procedure: Opioid Free Anesthesiapatients will receive opioid free anesthesia and bilateral ultrasound guided transversus abdominus plane block |
| Group II: Control group | Placebo comparator | Procedure: Control group (general anesthesia)patients will receive conventional general anesthesia |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 50 female patients aged 21-65 years.
- Patients with a Body mass index≥ 35 kg/m2
- American society of Anesthesiology class II-III.
- Undergoing elective gynecological surgeries.
Key exclusion criteria (7 listed)
- Patient refusal.
- History of allergy to local anesthetic.
- Liver or renal pathology affecting drug elimination.
- Mental dysfunction or cognitive disorders.
- Patients on chronic pain medications.
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 |
|---|---|---|
| Opioid Free Anesthesiapatients will receive opioid free anesthesia and bilateral ultrasound guided transversus abdominus plane block. | Procedure or surgery | Group I: Opioid Free Anesthesia group |
| Control group (general anesthesia)patients will receive conventional general anesthesia | Procedure or surgery | Group II: Control group |
Primary outcome
quality of recovery on postoperative day
Time frame: one day
The Quality of Recovery-40 questionnaire scores. The Quality of Recovery-40 questionnaire includes five dimensions of recovery: physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items).
1 secondary outcome
Postoperative pain severity
Time frame: 24 HOURS
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 11 Aug 2025.
- Individual participant dataSharing planned: Yes
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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.
Merihan Ahmed, Resident principal investigator
Tanta 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 Opioid Free Anesthesia in people with Anesthesia and Opioid, run by Tanta 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 4 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: opening soon, as of the sponsor's last update on 11 Aug 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 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. Some participants in this study may receive a placebo. 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 Merihan Ahmed, Resident (+20 11 11246871, mere4444.ma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of recovery on postoperative day (time frame: one day). 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 11 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.