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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vertebral Fractures; Discectomy
• Intervention / Treatment: Drug: Erector Spinae plane block (plain pubivicaine); Drug: Intravenous morphine group

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed A Abdelrahman, resident; Phone Number: 01092997390; Email: mohamed_aboelhamd_post@med.sohag.edu.eg
• Study Contact Backup: Name: Khaled M Hassan, assistant professor; Phone Number: 01144357827

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University Hospital
    • Contact: Osama R ElSherif, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Erector Spinae Plane block group; (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); 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.; Other Names: ESPB group
Active Comparator: Intravenous Morphine group; (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; patients will receive 0.1 mg /kg of intravenous morphine diluted to 10 ml volume using saline at the end of the operation.; Other Names: Morphine group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): November 20, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Spinal Injuries; Back Injuries; Spinal Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: Soh-Med-22-03-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No