An interventional study of ultrasound guided erector spinae plane block with bupivacaine 0.25% And ultrasound guided Paraveretebral block with bupivacaine 0.25 % in Comparison Between Ultrasound Guided Erector Spinae Plane Block and Para-vertebral Block on Acute and Chronic Post Mastectomy Pain, sponsored by South Egypt Cancer Institute. Recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-31.
Sponsored by South Egypt Cancer Institute · Not applicable, Interventional, and Diagnostic
Among 299 studies in Pain with a site in Egypt — 64 open to participants now, 79 under way, 5 of them phase 3. Pain · Egypt.
Among the 299 studies in Pain with a site in Egypt, this one is the 69th largest by planned enrollment of the 285 interventional ones that give a count, is one of 19 that started in 2020, is one of 189 with no phase, reaches primary completion later than 8 of the 78 other live ones, and was the 91st registered.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
Browse Pain studies →64 of the 299 studies in Pain with a site in Egypt are open now. Recruiting first, the newest first:
Tanta University · Sites in Egypt
Tanta University · Sites in Egypt
Tanta University · Sites in Egypt
Menoufia University · Sites in Egypt
Cairo University · Sites in Egypt
A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →
Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.
This study: 20 Years to 70 Years · female · healthy volunteers too.
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299 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 20 · Phase 2 41 · Phase 3 29 · Phase 4 25
First in 2007; this study’s year is marked. 19 started in 2020.
This study's planned enrollment of 108 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Median enrollment 62 across the 285 interventional studies, 40 across the 13 observational. Of the 182 that completed or were terminated, 2 (1%) have results posted.
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2 of 299 have an industry lead sponsor. The 10 most frequent:
South Egypt Cancer Institute is the lead sponsor of 35 studies on the registry; 7 are open to participants now.
South Egypt Cancer Institute has 3 studies filed under Pain — fewer than ten, so there is no comparison to draw.
15 of the studies in Pain with a site in Egypt that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07631416Sohag UniversityLumbar Erector Spinae Plane Block Versus Fascia Iliaca Plane Block in Hip Surgeries as Postoperative Analgesia | 2026-11-28 |
| NCT07773376Reem MohamedWarm Versus Room Temperature Saline as a Uterine Distension Medium for Pain Reduction in Women Undergoing Outpatient Hysteroscopy: Protocol for a Randomized Controlled Trial | 2026-12 |
| NCT07485517Menoufia UniversityDeep Versus Moderate Neuromuscular Blocking | 2026-12-01 |
| NCT07593300Misr University for Science and TechnologyRISS Versus Lower Thoracic ESP Block for Analgesia After Laparoscopic Abdominal Surgery: A Randomized Trial | 2026-12-31 |
| NCT07835191British University In EgyptEfficacy of Pre-cooling and Sweet-tasting Solution on Pain Related to Local Anesthesia Injection in Children | 2027-01 |
Among the 299 studies in Pain with a site in Egypt, from their registry updates:
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compare between ultrasound guided erector spinae plane block and ultrasound guided paravertebral block on acute and chronic post mastectomy pain
Management of postoperative analgesia following breast surgery extending beyond a simple lumpectomy can sometimes be a challenge, especially when such surgery is being performed as a day-case procedure. Patients undergoing mastectomy have a very high possibility of developing postsurgical pain syndrome, as high as 20% to 50%.There has been some evidence to suggest regional analgesia techniques reduce the incidence of postsurgical pain in patients undergoing mastectomy. This underlines the importance of performing regional anaesthetic and analgesic techniques for postoperative analgesia following breast surgery.There are many techniques of regional analgesia as thorasic epidural block , paravertebral block , PECS1 block ,PECS2 block , and recently erector spinae plan block.Paravertebral blocks have superseded thoracic epidurals when it comes to choice of a regional anaesthesia technique to provide analgesia for breast surgery.The injection of local anaesthetic solution in the paravertebral space results in a unilateral block, which is sensory, motor, and sympathetic. The uptake of the local anaesthetic solution is enhanced due to the absence of fascial sheaths binding the spinal nerves.TPVB produces ipsilateral somatic and sympathetic nerve blockade due to a direct effect of the local anesthetic on the somatic and sympathetic nerves in the TPVS, extension into the intercostal space laterally, and the epidural space medially. Ultrasound-guided erector spinae plane (US-ESP) block is a novel analgesic technique, in which local anaesthetic is injected into fascial plane deep to erector spinae muscle. It is possible to block the dorsal and ventral rami of the spinal nerve depending on the level of injection and amount of local anaesthetic injected. Erector spinae block (ESP) leads to effective post-operative analgesia where it is performed at T4-5 level for breast cancer and thoracic surgery , when performed bilaterally it has been reported to be as effective as thoracic epidural analgesia.The drug spreads in craniocaudal fashion over several levels as the erector spinae fascia extends from nuchal fascia cranially to the sacrum caudally. Forero et al. recently described US-ESP block for thoracic neuropathic pain. This block could be effective in both acute post-operative thoracic and abdominal surgeries and also neuropathic pain in these regions.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1-ASA > III 2 -age> 70 years old. 3-patients refusal to the procedure. 4-Infection of the skin at or near site of needle puncture. 5- Coagulopathy . 6- Drug or allergy to the studied drugs. 7- Central or peripheral neuropthy . 8-Pre-operative opoid consumption ( within 24 hours preoperative ) 9- Anomalies of the vertebral column .
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive standard regimen of anesthesia .
Procedure: ultrasound guided erector spinae plane block with bupivacaine 0.25% And ultrasound guided Paraveretebral block with bupivacaine 0.25 %
Patients will receive 0.25% bupivacaine (20 ml ) into interfascial plane below erector spinae muscle at level of T4.
Procedure: ultrasound guided erector spinae plane block with bupivacaine 0.25% And ultrasound guided Paraveretebral block with bupivacaine 0.25 %
Patients will receive (0.3 ml /kg ) 0.25% bubivicaine divided equially at each level of T2 , T4 and T6 at thoracic paravertebral space .
Procedure: ultrasound guided erector spinae plane block with bupivacaine 0.25% And ultrasound guided Paraveretebral block with bupivacaine 0.25 %
One groupvwill receive 0.25% bupivacaine (20 ml ) into interfascial plane below erector spinae muscle at level of T4 and the other group willreceive (0.3 ml /kg ) 0.25% bubivicaine divided equially at each level of T2 , T4 and T6 at thoracic paravertebral space .
analgesic requirement
Total morphine consumption during first 24 hours post operatively.
Time frame: 24 hours
stress response
Effect on stress response: serum level of cortisol and noradrenaline (immediately preoperative, after intubation, immediately postoperative, and after 24 hours postoperative)
Time frame: 24 hours
Chronic post mastectomy pain
Chronic post mastectomy will be assessed at pain clinic at 1st, 3rd, 6 th month postoperatively using (LANSS ) score .
Time frame: 6 month
Started May 2020 (actual). Primary completion is estimated for Dec 2023, 43 months after the start.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 43 months is above that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
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South Egypt Cancer Institute