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

Not Applicable

Not yet recruiting

• Conditions: Discectomy; Vertebral Fractures
• Interventions: Drug: Erector Spinae plane block (plain pubivicaine); Drug: Intravenous morphine group

• Registration Number: NCT05350696
• Lead Sponsor: Sohag University

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-28
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-07
• Study Start: 2023-11-20
• Primary Completion: 2023-12-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Lumbar Disc Prolapse.
• Fracture Lumbar Vertebrae

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector Spinae Plane block group	Erector Spinae plane block (plain pubivicaine)	(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 ).
Intravenous Morphine group	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.

Primary Outcome Measures

Name	Time	Method
Postoperative analgesia .	24 hours after surgery	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)

Secondary Outcome Measures

Name	Time	Method
Avoid side effects of using systemic morphine.	24 hours after surgery	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.

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt