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Clinical Trials/NCT05350696
NCT05350696
Not Yet Recruiting
N/A

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

Sohag University1 site in 1 country60 target enrollmentNovember 20, 2023

Overview

Phase
N/A
Intervention
Erector Spinae plane block (plain pubivicaine)
Conditions
Discectomy
Sponsor
Sohag University
Enrollment
60
Locations
1
Primary Endpoint
Postoperative analgesia .
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 20, 2023
End Date
January 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed Aboelhamed Abdelrahman

resident doctor at Anasthesia department sohag university hospital

Sohag University

Eligibility Criteria

Inclusion Criteria

  • Lumbar Disc Prolapse.
  • Fracture Lumbar Vertebrae

Exclusion Criteria

  • 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.

Arms & Interventions

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 ).

Intervention: Erector Spinae plane block (plain pubivicaine)

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.

Intervention: Intravenous morphine group

Outcomes

Primary Outcomes

Postoperative analgesia .

Time Frame: 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 Outcomes

  • Avoid side effects of using systemic morphine.(24 hours after surgery)

Study Sites (1)

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