Skip to content

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 .

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05350696
Enrollment
60
Registered
2022-04-28
Start date
2023-11-20
Completion date
2024-01-01
Last updated
2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Discectomy, Vertebral Fractures

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.

Interventions

DRUGErector 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.

DRUGIntravenous 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.

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative analgesia .24 hours after surgeryThe 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)

Secondary

MeasureTime frameDescription
Avoid side effects of using systemic morphine.24 hours after surgeryuse 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.

Countries

Egypt

Contacts

Primary ContactMohamed A Abdelrahman, resident
mohamed_aboelhamd_post@med.sohag.edu.eg01092997390
Backup ContactKhaled M Hassan, assistant professor
01144357827

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026