Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06131593
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2023-11-09
Brief Title:
TAP Block With Methyl-prednisolone as a Pain Treatment Modality After Total Abdominal Hysterectomy Procedures
Sponsor:
Kasr El Aini Hospital
Organization:
Kasr El Aini Hospital
Study Overview
Official Title:
TAP Block With Dexamethasone Versus TAP Block With Methyl-prednisolone as a Pain Treatment Modality After Total Abdominal Hysterectomy Procedures Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this work to compare between the efficacy of ultrasound guided TAP block with dexamethasone as an adjuvant versus ultrasound guided TAPB with methyl prednisolone as an adjuvant to local anesthetic for postoperative pain management in lower abdominal hysterectomy procedures
Detailed Description:
Patients will be divided in to two groups TAPB with dexamethasone as an adjuvant to local anesthetic Gr An25 and TAPB with methyl prednisolone as an adjuvant to local anesthetic Gr Bn25
By the end of surgery and with the patient in supine position and after covering of surgery site preparing the skin with povidone iodine a high frequency 5-10 MHZ ultrasound probe S-NerveTM SonoSite Inc Bothell WA USA will be placed transversally on abdominal wall between lower costal margin and iliac crest near midline After identifying the rectus abdominis muscle we will gradually move the ultrasound probe laterally to identify the transversus abdominis muscle lying posterior to the rectus muscle A 22 G echogenic needle using the in plane technique will be inserted medially aiming towards the iliac crest then 30ml total volume of 025 plain bupivacaine 15mgkg with lidocaine 1 3mgkg with 8mg dexamethasone in group A patients and 30ml total volume of 025 plain bupivacaine 15mgkg with lidocaine 1 3mgkg with 50 mg methylprednisolone in group B patients
Vital signs HR and non invasive blood pressure will be recorded at the onset of the block then every 20 min for an hour then every 4hrs for 12 hrs post operative
Postoperative
Paracetamol every 8 hours and ketorolac every 12 hours should be given as a part of multimodal analgesia and nalbuphine given as rescue analgesia and included in secondary outcomes
Post-operative assessment and analgesic regimen
Post operative pain assessment using VAS will be assessed 0-10 11 as zero refer to no pain and 10 refer to the worst pain after 1h of the block then every 4hrs for 12 hrs then every 8hrs for 48 hrs then after 72hrs The patient will be given Paracetamol every 8 hours and ketorolac every 12 hours The time to the first request of rescue post operative analgesic will be recorded when the patient complain of pain VAS 3 intravenous nalbuphine 5mg will be given total dose of nalbuphine will be recorded 24hrs
By the end of surgery and with the patient in supine position and after covering of surgery site preparing the skin with povidone iodine a high frequency 5-10 MHZ ultrasound probe S-NerveTM SonoSite Inc Bothell WA USA will be placed transversally on abdominal wall between lower costal margin and iliac crest near midline After identifying the rectus abdominis muscle we will gradually move the ultrasound probe laterally to identify the transversus abdominis muscle lying posterior to the rectus muscle A 22 G echogenic needle using the in plane technique will be inserted medially aiming towards the iliac crest then 30ml total volume of 025 plain bupivacaine 15mgkg with lidocaine 1 3mgkg with 8mg dexamethasone in group A patients and 30ml total volume of 025 plain bupivacaine 15mgkg with lidocaine 1 3mgkg with 50 mg methylprednisolone in group B patients
Vital signs HR and non invasive blood pressure will be recorded at the onset of the block then every 20 min for an hour then every 4hrs for 12 hrs post operative
Postoperative
Paracetamol every 8 hours and ketorolac every 12 hours should be given as a part of multimodal analgesia and nalbuphine given as rescue analgesia and included in secondary outcomes
Post-operative assessment and analgesic regimen
Post operative pain assessment using VAS will be assessed 0-10 11 as zero refer to no pain and 10 refer to the worst pain after 1h of the block then every 4hrs for 12 hrs then every 8hrs for 48 hrs then after 72hrs The patient will be given Paracetamol every 8 hours and ketorolac every 12 hours The time to the first request of rescue post operative analgesic will be recorded when the patient complain of pain VAS 3 intravenous nalbuphine 5mg will be given total dose of nalbuphine will be recorded 24hrs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None