NephrectomyPhase 2/3DEX/FentanylNCT06799442
Dexmedetomidine Versus Fentanyl as Adjuvants to Erector Spinae Plane Block for Postoperative Analgesia Following Simple Nephrectomy: A Randomized Clinical Trial
A Phase 2/3 study testing Erector Spinae Plane Block, Dexmedetomidine and fentanyl in people with Nephrectomy, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this clinical trial is to compare the time to first analgesic request between dexmedetomidine and fentanyl as adjuvants in erector spinae plane block in patients undergoing simple nephrectomy . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrectomy
- What is being tested?
- Erector Spinae Plane Block, Dexmedetomidine and fentanyl
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 1 Mar 2026
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years old Both sex patients who are American society of Anesthesiologists class I or
Who cannot join
- Patient's refusal.
- body mass index (BMI) ≥40 kg/m2.
- Local infection at site of block.
- Spine deformities
- History of hypersensitivity to the drugs being evaluated
- Inability to comprehend postoperatively the pain assessment scale/neuropsychiatric disorders.
- Chronic use of opioids and opioid addiction
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this clinical trial is to compare the time to first analgesic request between dexmedetomidine and fentanyl as adjuvants in erector spinae plane block in patients undergoing simple nephrectomy .
- Secondary outcome Pain scores; Numerical Rating Scale (NRS) at rest and when coughing [at 1, 2, 4, 8, 16 and 24 hours postoperatively.] The total opiod dose in the first 24 hours postoperatively. Duration of analgesia is defined as duration between block administration and time of first analgesic request.
Read more
Any adverse effects related to anesthesia or the technique. Incidence of Postoperative nausea \& vomiting . Block related complication during and after block procedure till 24hours postoperatively (local anesthetic systemic toxicity, pneumothorax and vascular puncture during block procedure).
Intraoperative haemodynamics parameters MAP ,HR , co2 and SP O2 . Postoperative haemodynamics parameters MAP , HR and SP O2 [at 1, 2, 4, 8, 16 and 24 hours postoperatively. ]
Read the detailed description
An independent anesthesiologist randomly divided the patients into 2 groups of 23 patients each using computer-generated random numbers dexmedetomidine group and fentanyl group (Group D and Group F). We discreetly placed the randomization results in envelopes until the end of the study. Both dexmedetomidine and fentanyl are colourless liquids, and they were digitally encoded after being diluted to 2 ml so that the researchers who are responsible for postoperative follow-up and data processing are blinded to the group allocation during the whole study period. All patients are also blinded to the group allocation.
A)Anaesthesia induction:
Standard monitoring procedures will include pulse oximetry, electrocardiography, and noninvasive arterial pressure prior to anesthetic induction. All patients will be premedicated with intravenous (i.v.) midazolam 1-2 mg and antibiotic prophylaxis, according to the hospital's protocol. Anesthesia will be induced with intravenously (IV)-administered propofol 2 mg/kg, fentanyle 1 mic kg following which endotracheal intubation will be facilitated by atracurium 0.5 mg / kg. Anesthesia will be maintained with oxygen, air, and isoflurane using controlled ventilation with closed circuit in order to ensure normocarbia. Regular doses of atracurium 0.25 mg / kg will be given every 20 minutes to ensure proper muscle relaxation. After positioning the patient of the surgery, patients will receive their intervention according to group allocation under sterile conditions.
B)Intervention:
Erector Spinae Plane Block:
Patients will be placed in lateral position with the surgical site upward. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. An echogenic needle needle will be inserted using an in-plane approach and craniocaudally direction. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging.
Group D patients: A total of 30 ml Bupivacaine 0. 25%+ 50 mic dexmedetomidine which is diluted to 2ml.
Group F patients : A total of 30 ml Bupivacaine 0.25% + 100 mic fentanyl which is also diluted to 2 ml.
Intraoperativeely
The following parameters will be monitored intraoperatively :
HR and MAP and SpO2 and CO2 will be documented at induction, intubation, surgical incision and every 15 min. till the end of surgery.
- Perflgan 1gm and Ondansetron 0.1 mg/kg will be given at the end of the procedure to all patients.
- Neuromuscular blockade will be reversed with neostigmine and atropine at the end of the procedure.
Post operative
- Postoperative pain will be assessed using an 11-point (0=no pain and 10=worst pain) numeric rating scale (NRS). NRS for pain at rest and when coughing will be assessed serially at 1, 2, 4, 8, 16 and 24 h after surgery. The assessor and the patients will be unaware of the type of intervention received.
- Rescue analgesics will be administered when NRS ≥4 or when the patient complains of pain. In the firm of the nalbuphine 0.1 mg /kg
- Time for first analgesic request will be recorded. The duration of analgesia will be evaluated as the time from block administration to the time of first analgesic. Total doses of rescue analgesics required in the first 24 h will be recorded.
- The presence of postoperative nausea and vomiting during the first 24 h will be recorded. Postoperative nausea or vomiting will be treated with 0.1 mg/kg of ondansetron. If the patient did not respond to ondansetron, then dexamethasone 8 mg or metoclopramide 10 mg will be given IV. Occurrence of any complications such as haematoma, bleeding, local anesthetic systemic toxicity, pneumothorax and allergic reactions will also be observed.
- Conditions
- Nephrectomy
- Being tested
- Erector Spinae Plane Block, Dexmedetomidine, fentanyl
- Keywords
- Postoperative pain relief
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
Patients will be placed in lateral position with the surgical site upward. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. An echogenic needle needle will be inserted using an in-plane approach and craniocaudally direction. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging.
DexmedetomidineDrug
50 mic dexmedetomidine which is diluted to 2ml.
fentanylDrug
100 mic fentanylwhich is also diluted to 2 ml.
| Study group | Role | What they receive |
|---|---|---|
| Group dexmedetomidine | Active comparator | Patients will be placed in lateral position with the surgical site upward. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. An echogenic needle needle will be inserted using an in-plane approach and craniocaudally direction. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. Group D patients: A total of 30 ml Bupivacaine 0. 25%+ 50 mic dexmedetomidine which is diluted to 2ml. |
| Group fentanyl | Active comparator | Patients will be placed in lateral position with the surgical site upward. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. An echogenic needle needle will be inserted using an in-plane approach and craniocaudally direction. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. Group F patients : A total of 30 ml Bupivacaine 0.25% + 100 mic fentanyl which is also diluted to 2 ml. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time to first analgesic request
To compare the time to first analgesic request between dexmedetomidine and fentanyl as adjuvants in erector spinae plane block in patients undergoing simple nephrectomy .
Measured: 24 hours
Secondary outcomes (4)
Pain scores
Numerical Rating Scale (NRS) when coughing
Measured: 24 hours
The total opiod dose
The total opiod dose postoperatively
Measured: 24 hours
Duration of analgesia
Duration of analgesia is defined as duration between block administration and time of first analgesic request.
Measured: 24 hours
Postoperative nausea & vomiting
Incidence of Postoperative nausea \& vomiting
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 posted29 Jan 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for NephrectomyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be placed in lateral position with the surgical site upward. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. An echogenic needle needle will be inserted using an in-plane approach and craniocaudally direction. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. Group D patients: A total of 30 ml Bupivacaine 0. 25%+ 50 mic dexmedetomidine which is diluted to 2ml. Group F patients : A total of 30 ml Bupivacaine 0.25% + 100 mic fentanyl which is also diluted to 2 ml.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Bahgat Haleem Zaki, Assiut University
- Investigators
- Moamen Mostafa Makkey, Doctor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799442
- Sponsor's protocol ID
- DEX/Fentanyl ESPB Nephrectomy
- Acronym
- DEX/Fentanyl
- Status last verified
- Sep 2024
- First submitted
- 23 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Waloejo CS, Musalim DAP, Budi DS, Pratama NR, Sulistiawan SS, Wungu CDK. Dexmedetomidine as an Adjuvant to Nerve Block for Cancer Surgery: A Systematic Review and Meta-Analysis. J Clin Med. 2024 May 28;13(11):3166. doi: 10.3390/jcm13113166.
PubMed 38892876Ivanusic J, Konishi Y, Barrington MJ. A Cadaveric Study Investigating the Mechanism of Action of Erector Spinae Blockade. Reg Anesth Pain Med. 2018 Aug;43(6):567-571. doi: 10.1097/AAP.0000000000000789.
PubMed 29746445Adhikary SD, Bernard S, Lopez H, Chin KJ. Erector Spinae Plane Block Versus Retrolaminar Block: A Magnetic Resonance Imaging and Anatomical Study. Reg Anesth Pain Med. 2018 Oct;43(7):756-762. doi: 10.1097/AAP.0000000000000798.
PubMed 29794943De la Cuadra-Fontaine JC, Concha M, Vuletin F, Arancibia H. Continuous Erector Spinae Plane block for thoracic surgery in a pediatric patient. Paediatr Anaesth. 2018 Jan;28(1):74-75. doi: 10.1111/pan.13277. No abstract available.
PubMed 29226529Finneran JJ 4th, Gabriel RA, Khatibi B. Erector Spinae Plane Blocks Provide Analgesia for Breast and Axillary Surgery: A Series of 3 Cases. Reg Anesth Pain Med. 2018 Jan;43(1):101-102. doi: 10.1097/AAP.0000000000000695. No abstract available.
PubMed 29261601Bonvicini D, Giacomazzi A, Pizzirani E. Use of the ultrasound-guided erector spinae plane block in breast surgery. Minerva Anestesiol. 2017 Oct;83(10):1111-1112. doi: 10.23736/S0375-9393.17.12015-8. Epub 2017 May 11. No abstract available.
PubMed 28492298Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581.
PubMed 28272292Capdevila X, Moulard S, Plasse C, Peshaud JL, Molinari N, Dadure C, Bringuier S. Effectiveness of Epidural Analgesia, Continuous Surgical Site Analgesia, and Patient-Controlled Analgesic Morphine for Postoperative Pain Management and Hyperalgesia, Rehabilitation, and Health-Related Quality of Life After Open Nephrectomy: A Prospective, Randomized, Controlled Study. Anesth Analg. 2017 Jan;124(1):336-345. doi: 10.1213/ANE.0000000000001688.
PubMed 27918333Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016Misiolek H, Cettler M, Woron J, Wordliczek J, Dobrogowski J, Mayzner-Zawadzka E. The 2014 guidelines for post-operative pain management. Anaesthesiol Intensive Ther. 2014 Sep-Oct;46(4):221-44. doi: 10.5603/AIT.2014.0041. No abstract available.
PubMed 25293474Sharma V, Margreiter M. Partial nephrectomy: is there still a need for open surgery? Curr Urol Rep. 2013 Feb;14(1):1-4. doi: 10.1007/s11934-012-0297-2.
PubMed 23233109Sahin A, Baran O. Effect of ultrasound-guided erector spinae plane block on post-surgical pain in patients undergoing nephrectomy: a single-center, randomized, double-blind, controlled trial. J Int Med Res. 2022 Mar;50(3):3000605221086737. doi: 10.1177/03000605221086737.
PubMed 35301896
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Fentanyl as Adjuvants to Erector Spinae Plane Block for Postoperative Analgesia Following Simple Nephrectomy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06799442
- Acronym / sponsor ID
- DEX/Fentanyl / DEX/Fentanyl ESPB Nephrectomy
- Conditions
- Nephrectomy
- Keywords
- Postoperative pain relief
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 29 Jan 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.
The aim of this clinical trial is to compare the time to first analgesic request between dexmedetomidine and fentanyl as adjuvants in erector spinae plane block in patients undergoing simple nephrectomy .
- Secondary outcome Pain scores; Numerical Rating Scale (NRS) at rest and when coughing [at 1, 2, 4, 8, 16 and 24 hours postoperatively.] The total opiod dose in the first 24 hours postoperatively. Duration of analgesia is defined as duration between block administration and time of first analgesic request.
Any adverse effects related to anesthesia or the technique. Incidence of Postoperative nausea \& vomiting . Block related complication during and after block procedure till 24hours postoperatively (local anesthetic systemic toxicity, pneumothorax and vascular puncture during block procedure).
Intraoperative haemodynamics parameters MAP ,HR , co2 and SP O2 . Postoperative haemodynamics parameters MAP , HR and SP O2 [at 1, 2, 4, 8, 16 and 24 hours postoperatively. ]
Detailed description
An independent anesthesiologist randomly divided the patients into 2 groups of 23 patients each using computer-generated random numbers dexmedetomidine group and fentanyl group (Group D and Group F). We discreetly placed the randomization results in envelopes until the end of the study. Both dexmedetomidine and fentanyl are colourless liquids, and they were digitally encoded after being diluted to 2 ml so that the researchers who are responsible for postoperative follow-up and data processing are blinded to the group allocation during the whole study period. All patients are also blinded to the group allocation.
A)Anaesthesia induction:
Standard monitoring procedures will include pulse oximetry, electrocardiography, and noninvasive arterial pressure prior to anesthetic induction. All patients will be premedicated with intravenous (i.v.) midazolam 1-2 mg and antibiotic prophylaxis, according to the hospital's protocol. Anesthesia will be induced with intravenously (IV)-administered propofol 2 mg/kg, fentanyle 1 mic kg following which endotracheal intubation will be facilitated by atracurium 0.5 mg / kg. Anesthesia will be maintained with oxygen, air, and isoflurane using controlled ventilation with closed circuit in order to ensure normocarbia. Regular doses of atracurium 0.25 mg / kg will be given every 20 minutes to ensure proper muscle relaxation. After positioning the patient of the surgery, patients will receive their intervention according to group allocation under sterile conditions.
B)Intervention:
Erector Spinae Plane Block:
Patients will be placed in lateral position with the surgical site upward. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. An echogenic needle needle will be inserted using an in-plane approach and craniocaudally direction. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging.
Group D patients: A total of 30 ml Bupivacaine 0. 25%+ 50 mic dexmedetomidine which is diluted to 2ml.
Group F patients : A total of 30 ml Bupivacaine 0.25% + 100 mic fentanyl which is also diluted to 2 ml.
Intraoperativeely
The following parameters will be monitored intraoperatively :
HR and MAP and SpO2 and CO2 will be documented at induction, intubation, surgical incision and every 15 min. till the end of surgery.
- Perflgan 1gm and Ondansetron 0.1 mg/kg will be given at the end of the procedure to all patients.
- Neuromuscular blockade will be reversed with neostigmine and atropine at the end of the procedure.
Post operative
- Postoperative pain will be assessed using an 11-point (0=no pain and 10=worst pain) numeric rating scale (NRS). NRS for pain at rest and when coughing will be assessed serially at 1, 2, 4, 8, 16 and 24 h after surgery. The assessor and the patients will be unaware of the type of intervention received.
- Rescue analgesics will be administered when NRS ≥4 or when the patient complains of pain. In the firm of the nalbuphine 0.1 mg /kg
- Time for first analgesic request will be recorded. The duration of analgesia will be evaluated as the time from block administration to the time of first analgesic. Total doses of rescue analgesics required in the first 24 h will be recorded.
- The presence of postoperative nausea and vomiting during the first 24 h will be recorded. Postoperative nausea or vomiting will be treated with 0.1 mg/kg of ondansetron. If the patient did not respond to ondansetron, then dexamethasone 8 mg or metoclopramide 10 mg will be given IV. Occurrence of any complications such as haematoma, bleeding, local anesthetic systemic toxicity, pneumothorax and allergic reactions will also be observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be placed in lateral position with the surgical site upward. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. An echogenic needle needle will be inserted using an in-plane approach and craniocaudally direction. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. Group D patients: A total of 30 ml Bupivacaine 0. 25%+ 50 mic dexmedetomidine which is diluted to 2ml. Group F patients : A total of 30 ml Bupivacaine 0.25% + 100 mic fentanyl which is also diluted to 2 ml.
| Arm | Type | Receives |
|---|---|---|
| Group dexmedetomidine | Active comparator | –Patients will be placed in lateral position with the surgical site upward. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. An echogenic needle needle will be inserted using an in-plane approach and craniocaudally direction. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. Group D patients: A total of 30 ml Bupivacaine 0. 25%+ 50 mic dexmedetomidine which is diluted to 2ml. |
| Group fentanyl | Active comparator | –Patients will be placed in lateral position with the surgical site upward. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. An echogenic needle needle will be inserted using an in-plane approach and craniocaudally direction. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. Group F patients : A total of 30 ml Bupivacaine 0.25% + 100 mic fentanyl which is also diluted to 2 ml. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age >18 years old Both sex patients who are American society of Anesthesiologists class I or
Key exclusion criteria (7 listed)
- Patient's refusal.
- body mass index (BMI) ≥40 kg/m2.
- Local infection at site of block.
- Spine deformities
- History of hypersensitivity to the drugs being evaluated
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 |
|---|---|---|
| Erector Spinae Plane BlockPatients will be placed in lateral position with the surgical site upward. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. An echogenic needle needle will be inserted using an in-plane approach and craniocaudally direction. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. | Procedure or surgery | – |
| Dexmedetomidine50 mic dexmedetomidine which is diluted to 2ml. | Drug | – |
| fentanyl100 mic fentanylwhich is also diluted to 2 ml. | Drug | – |
Primary outcome
the time to first analgesic request
Time frame: 24 hours
To compare the time to first analgesic request between dexmedetomidine and fentanyl as adjuvants in erector spinae plane block in patients undergoing simple nephrectomy .
4 secondary outcomes
Pain scores
Time frame: 24 hours
The total opiod dose
Time frame: 24 hours
Duration of analgesia
Time frame: 24 hours
Postoperative nausea & vomiting
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Results publication: PubMed 38892876Waloejo CS, Musalim DAP, Budi DS, Pratama NR, Sulistiawan SS, Wungu CDK. Dexmedetomidine as an Adjuvant to Nerve Block for Cancer Surgery: A Systematic Review and Meta-Analysis. J Clin Med. 2024 May 28;13(11):3166. doi: 10.3390/jcm13113166.
- Results publication: PubMed 29746445Ivanusic J, Konishi Y, Barrington MJ. A Cadaveric Study Investigating the Mechanism of Action of Erector Spinae Blockade. Reg Anesth Pain Med. 2018 Aug;43(6):567-571. doi: 10.1097/AAP.0000000000000789.
- Results publication: PubMed 29794943Adhikary SD, Bernard S, Lopez H, Chin KJ. Erector Spinae Plane Block Versus Retrolaminar Block: A Magnetic Resonance Imaging and Anatomical Study. Reg Anesth Pain Med. 2018 Oct;43(7):756-762. doi: 10.1097/AAP.0000000000000798.
- Results publication: PubMed 29226529De la Cuadra-Fontaine JC, Concha M, Vuletin F, Arancibia H. Continuous Erector Spinae Plane block for thoracic surgery in a pediatric patient. Paediatr Anaesth. 2018 Jan;28(1):74-75. doi: 10.1111/pan.13277. No abstract available.
- Results publication: PubMed 29261601Finneran JJ 4th, Gabriel RA, Khatibi B. Erector Spinae Plane Blocks Provide Analgesia for Breast and Axillary Surgery: A Series of 3 Cases. Reg Anesth Pain Med. 2018 Jan;43(1):101-102. doi: 10.1097/AAP.0000000000000695. No abstract available.
- Results publication: PubMed 28492298Bonvicini D, Giacomazzi A, Pizzirani E. Use of the ultrasound-guided erector spinae plane block in breast surgery. Minerva Anestesiol. 2017 Oct;83(10):1111-1112. doi: 10.23736/S0375-9393.17.12015-8. Epub 2017 May 11. No abstract available.
- Results publication: PubMed 28272292Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581.
- Results publication: PubMed 27918333Capdevila X, Moulard S, Plasse C, Peshaud JL, Molinari N, Dadure C, Bringuier S. Effectiveness of Epidural Analgesia, Continuous Surgical Site Analgesia, and Patient-Controlled Analgesic Morphine for Postoperative Pain Management and Hyperalgesia, Rehabilitation, and Health-Related Quality of Life After Open Nephrectomy: A Prospective, Randomized, Controlled Study. Anesth Analg. 2017 Jan;124(1):336-345. doi: 10.1213/ANE.0000000000001688.
- Results publication: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Results publication: PubMed 25293474Misiolek H, Cettler M, Woron J, Wordliczek J, Dobrogowski J, Mayzner-Zawadzka E. The 2014 guidelines for post-operative pain management. Anaesthesiol Intensive Ther. 2014 Sep-Oct;46(4):221-44. doi: 10.5603/AIT.2014.0041. No abstract available.
- Results publication: PubMed 23233109Sharma V, Margreiter M. Partial nephrectomy: is there still a need for open surgery? Curr Urol Rep. 2013 Feb;14(1):1-4. doi: 10.1007/s11934-012-0297-2.
- Results publication: PubMed 35301896Sahin A, Baran O. Effect of ultrasound-guided erector spinae plane block on post-surgical pain in patients undergoing nephrectomy: a single-center, randomized, double-blind, controlled trial. J Int Med Res. 2022 Mar;50(3):3000605221086737. doi: 10.1177/03000605221086737.
- Individual participant dataSharing planned: Undecided
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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.
Moamen Mostafa Makkey, Doctor study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Erector Spinae Plane Block, Dexmedetomidine and fentanyl in people with Nephrectomy, run by Assiut 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 1 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: status not confirmed, as of the sponsor's last update on 29 Jan 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa Mohamed Atia, Professor (01099923117, alaaguhina@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time to first analgesic request (time frame: 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 NCT06799442, which also lists 12 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 29 Jan 2025.