search
Back to results

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

Primary Purpose

Discectomy, Vertebral Fractures

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Erector Spinae plane block (plain pubivicaine)
Intravenous morphine group
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Discectomy

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sohag University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Erector Spinae Plane block group

Intravenous Morphine group

Arm Description

(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 ).

(30 patients) will receive 0.1 mg /kg of intravenous morphine diluted to 10 ml volume using saline at the end of the operation.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

Full Information

First Posted
March 15, 2022
Last Updated
October 25, 2022
Sponsor
Sohag University
search

1. Study Identification

Unique Protocol Identification Number
NCT05350696
Brief Title
Comparative Study Between ESPB Versus IV Morphine as Postoperative Analgesia After Spine Surgeries .
Official Title
Comparative Study Between Erector Spinae Plane Block Versus Intravenous Morphine as Postoperative Analgesia After Spine Surgeries .
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 16, 2022 (Anticipated)
Primary Completion Date
January 16, 2023 (Anticipated)
Study Completion Date
February 16, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Discectomy, Vertebral Fractures

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Erector Spinae Plane block group
Arm Type
Active Comparator
Arm Description
(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 ).
Arm Title
Intravenous Morphine group
Arm Type
Active Comparator
Arm Description
(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 Type
Drug
Intervention Name(s)
Erector Spinae plane block (plain pubivicaine)
Other Intervention Name(s)
ESPB group
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Intravenous morphine group
Other Intervention Name(s)
Morphine group
Intervention Description
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 Measure Information:
Title
Postoperative analgesia .
Description
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)
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Avoid side effects of using systemic morphine.
Description
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.
Time Frame
24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed A Abdelrahman, resident
Phone
01092997390
Email
mohamed_aboelhamd_post@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Khaled M Hassan, assistant professor
Phone
01144357827
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama R ElSherif, professor

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28203765
Citation
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.
Results Reference
background
PubMed Identifier
27501016
Citation
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.
Results Reference
background
PubMed Identifier
29704223
Citation
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.
Results Reference
background
PubMed Identifier
31343504
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs