An interventional study of Erector Spinae plane block (plain pubivicaine) and Intravenous morphine group in Discectomy and Vertebral Fractures, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to participants aged 15 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by Sohag University · Not applicable, Interventional, and Prevention
Postoperative pain is often severe in patients undergoing lumbar surgery. Due to postoperative pain, patients are unwilling to get out of bed at an early stage, which affects their recovery.
Erector spinae plane block (ESPB) as a new trunk fascia block technique was proposed in 2016. ESPB has aroused the interest of many nerve block experts. The benefits of ESPB are not yet demonstrated. The specific mechanism is still controversial.
The erector spinae block is achieved by injecting the local anesthetic solution (with possible adjuvants) between the erector spinae muscles (iliocostalis, longissimus, spinalis/ from lateral to medial) and the transverse process .
The technique is performed under ultrasound guidance.
164 studies on the registry are indexed under Spinal Fractures; 29 are open to participants now.
This study's planned enrollment of 60 is below the median of 76 across 100 interventional studies indexed under Spinal Fractures.
Browse Spinal Fractures studies →Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.
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Exclusion Criteria:
(30 patients) will receive bilateral ultrasound guided erector spinae plane block using plain bupivacaine 100 mg diluted to volume using normal saline to achieve 50% concentration ( 50 mg plain pubivicaine in each side ).
Drug: Erector Spinae plane block (plain pubivicaine)
(30 patients) will receive 0.1 mg /kg of intravenous morphine diluted to 10 ml volume using saline at the end of the operation.
Drug: Intravenous morphine group
The erector spinae block is achieved by injecting the local anesthetic solution (with possible adjuvants) between the erector spinae muscles (iliocostalis, longissimus, spinalis/ from lateral to medial) and the transverse process . The technique is performed under ultrasound guidance.
Also known as: ESPB group
patients will receive 0.1 mg /kg of intravenous morphine diluted to 10 ml volume using saline at the end of the operation.
Also known as: Morphine group
Postoperative analgesia .
The study will include 60 adult patients undergoing uncomplicated spine surgery under general anesthesia. At the end of operation , Patients will be randomly divided using closed enveloped method into two equal groups. * Group 1, (30 patients) will receive bilateral ultrasound guided erector spinae plane block using plain bupivacaine 100 mg diluted to volume using normal saline to achieve 50% concentration ( 50 mg plain pubivicaine in each side ). * Group 2, (30 patients) will receive 0.1 mg /kg of intravenous morphine diluted to 10 ml volume using saline at the end of the operation. postoperative pain assessment according to visual analogue scale ( VAS ) within 24 hours after the surgery. 0 - 3 mild pain ( better outcome ) 4 - 6 moderate pain 7 - 10 severe pain \> 10 unbearable pain ( worst outcome)
Time frame: 24 hours after surgery
Avoid side effects of using systemic morphine.
use of intravenous morphine is mostly followed by undesirable side effects such as postoperative nausea and vomiting,urine retention and constipation. so the target of this study is to show that if ESPB is more preferrable to IV morphine as regard both : postoperative anagesia and avoidance of side effects of systemic morphine. patients of morphine group will be asked about having nausea or vomiting after surgery and over 24 hours after the operation.
Time frame: 24 hours after surgery
Plan to share: Undecided
This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Sohag University