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

NCT05350696 | Unknown

• 1 other identifier: Soh-Med-22-03-10
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Discectomy; Vertebral Fractures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Avoid side effects of using systemic morphine.

  24 hours after surgery

Study Arms (2)

Erector Spinae Plane block group

ACTIVE COMPARATOR

(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)

Intravenous Morphine group

ACTIVE COMPARATOR

(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

Interventions

Erector Spinae plane block (plain pubivicaine) DRUG

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

Erector Spinae Plane block group

Intravenous morphine group DRUG

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

Intravenous Morphine group

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Lumbar Disc Prolapse.
• Fracture Lumbar Vertebrae

You may not qualify if:

• Patient refusal.
• Drug abuse.
• Patient with significant neurological, psychiatric or neuromuscular disease.
• Chronic pain on medicine.
• known allergy to the study medications.
• Infection at the site of infiltration.
• Patients with bleeding tendency.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

• 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.

  PMID: 28203765 BACKGROUND

• 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.

  PMID: 27501016 BACKGROUND

• 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.

  PMID: 29704223 BACKGROUND

• 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.

  PMID: 31343504 BACKGROUND

MeSH Terms

Conditions

Spinal Fractures

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Central Study Contacts

Mohamed A Abdelrahman, resident

CONTACT

01092997390; mohamed_aboelhamd_post@med.sohag.edu.eg

Khaled M Hassan, assistant professor

CONTACT

01144357827

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at Anasthesia department sohag university hospital

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 28, 2022
• Study Start: November 20, 2023
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

EG (1)