Comparative Study Between ESPB Versus IV Morphine as Postoperative Analgesia After Spine Surgeries .

Vertebral Fractures Clinical Trial

Official title:

Comparative Study Between Erector Spinae Plane Block Versus Intravenous Morphine as Postoperative Analgesia After Spine Surgeries .

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05350696
• Other study ID #: Soh-Med-22-03-10
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: November 2023
• Source: Sohag University
• Contact: Mohamed A Abdelrahman, resident
• Phone: 01092997390
• Email: mohamed_aboelhamd_post[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

Inclusion Criteria:

• Lumbar Disc Prolapse.
• Fracture Lumbar Vertebrae

Exclusion Criteria:

1. Patient refusal.

2. Drug abuse.

3. Patient with significant neurological, psychiatric or neuromuscular disease.

4. Chronic pain on medicine.

5. known allergy to the study medications.

6. Infection at the site of infiltration.

7. Patients with bleeding tendency.

Related Conditions & MeSH terms

• Spinal Fractures
• Vertebral Fractures

Intervention

Drug:
• Erector Spinae plane block (plain pubivicaine)
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.
• Intravenous morphine group
patients will receive 0.1 mg /kg of intravenous morphine diluted to 10 ml volume using saline at the end of the operation.

Locations

Country	Name	City	State
Egypt	Sohag University Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Forero 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. — View Citation

Hamilton DL, Manickam B. Erector spinae plane block for pain relief in rib fractures. Br J Anaesth. 2017 Mar 1;118(3):474-475. doi: 10.1093/bja/aex013. No abstract available. — View Citation

Melvin JP, Schrot RJ, Chu GM, Chin KJ. Low thoracic erector spinae plane block for perioperative analgesia in lumbosacral spine surgery: a case series. Can J Anaesth. 2018 Sep;65(9):1057-1065. doi: 10.1007/s12630-018-1145-8. Epub 2018 Apr 27. — View Citation

Tseng V, Xu JL. Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: Is There a Better Option? J Neurosurg Anesthesiol. 2021 Jan;33(1):92. doi: 10.1097/ANA.0000000000000631. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	24 hours after surgery
Secondary	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.	24 hours after surgery