search
Back to results

Erector Spinae Plane Block for Postoperative Pain Control in Hip Replacement Surgeries

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound-guided Erector spinae plane block
subarachonoid block
Sponsored by
Bassant M. Abdelhamid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged from 40 to 65 years old
  • Both sexes.
  • ASA I-II.
  • Undergo hip replacement surgery.
  • Body mass index (BMI) from 18 to 35 kg/m2.

Exclusion Criteria:

  • Patient refusal.
  • Contraindication to regional anesthesia (bleeding disorder, use of any anticoagulants, local infection, etc. )
  • BMI > 35.
  • Known allergy to local anesthetics.
  • ASA III-IV.
  • Patients with difficulty in evaluating their level of pain.

Sites / Locations

  • Anesthesia Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ESP group

Control group

Arm Description

patients will have ultrasound guided ESP block before spinal anesthesia.

patients will have spinal Anesthesia without ESP block

Outcomes

Primary Outcome Measures

Total morphine consumption
Total morphine consumption in rescue boluses during 1st 24 hrs postoperatively.

Secondary Outcome Measures

Visual analogue scale
Visual analogue scale at the following intervals:30 minutes,2,4, 6, 12, and 24 hours postoperative.
Duration of analgesia
defined as the time interval from completion of local anesthetic administration till first need of rescue analgesic in the form of iv morphine
Incidence of complications
Nerve injury, Hematoma formation, LA toxicity, Intravascular injection.

Full Information

First Posted
June 26, 2019
Last Updated
November 5, 2019
Sponsor
Bassant M. Abdelhamid
search

1. Study Identification

Unique Protocol Identification Number
NCT04003909
Brief Title
Erector Spinae Plane Block for Postoperative Pain Control in Hip Replacement Surgeries
Official Title
Effectiveness of Ultrasound-guided Erector Spinae Plane Block for Postoperative Pain Control in Hip Replacement Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 5, 2019 (Actual)
Primary Completion Date
October 5, 2019 (Actual)
Study Completion Date
November 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bassant M. Abdelhamid

4. Oversight

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

5. Study Description

Brief Summary
ESP block advantages include its simplicity, easy identifiable ultrasonographic landmarks and low risk for serious complications as injection is into tissue plane that is distant from pleura, major blood vessels and discrete nerves. Coupled with the fact that the erector spinae muscle and ESP extend down to the lumbar spine, ESP block was hypothesized to be performed at the level of L4. In a recent case report, ultrasound guided ESP block was successfully performed at L4 transverse process level for postoperative analgesia after total hip arthroplasty. However, confirmation of the efficacy of ESP block in hip replacement surgeries needed more investigation.
Detailed Description
This study will be performed in Cairo university hospital. Thirty adult patients of both sexes scheduled for hip replacement surgery under spinal anesthesia will be enrolled in the study. All patients meeting the inclusion criteria will be randomly assigned to one of 2 groups, 15 per group: Group E, ESP group (n=15): prior to surgical incision, patients will have ultrasound guided ESP block before spinal anesthesia. Group C, Control group (n=15): prior to surgical incision, patients will have spinal Anesthesia without ESP block . Patients will be randomly allocated by a computer-generated table into one of the study groups, the randomization sequence will be concealed in sealed opaque envelopes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESP group
Arm Type
Experimental
Arm Description
patients will have ultrasound guided ESP block before spinal anesthesia.
Arm Title
Control group
Arm Type
Experimental
Arm Description
patients will have spinal Anesthesia without ESP block
Intervention Type
Procedure
Intervention Name(s)
ultrasound-guided Erector spinae plane block
Intervention Description
The patients will be in lateral position. A curvilinear array ultrasound probe will be placed in a transverse orientation at L4 level to identify the tip of the L4 transverse process. Local anesthetic infiltration of the superficial tissues, an echogenic 22-G block needle will be inserted inplane to the ultrasound beam in a cranial-to-caudal direction until contact made with the L4 transverse process. Correct location of the needle tip in the fascial plane deep to erector spinae muscle will be confirmed by injecting 0.5-1ml saline and seeing the fluid lifting the erector spinae muscle off the transverse process while not distending the muscle. A total volume of 20ml bupivicaine 0.25% and 20 ml xylocaine 1% will be injected into the ESP on the affected side.
Intervention Type
Procedure
Intervention Name(s)
subarachonoid block
Intervention Description
Local anesthesia 2ml of lidocaine 2% will be applied intradermally to the needle entrance point. A 22-G block needle will be inserted, free cerebrospinal fluid flow will be observed and 20mg of hyperbaric bupivacaine 0.5% and 10μg of fentanyl will be injected for 30 seconds.
Primary Outcome Measure Information:
Title
Total morphine consumption
Description
Total morphine consumption in rescue boluses during 1st 24 hrs postoperatively.
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
Visual analogue scale
Description
Visual analogue scale at the following intervals:30 minutes,2,4, 6, 12, and 24 hours postoperative.
Time Frame
30 minutes,2,4, 6, 12, and 24 hours postoperative.
Title
Duration of analgesia
Description
defined as the time interval from completion of local anesthetic administration till first need of rescue analgesic in the form of iv morphine
Time Frame
24 hours postoperative
Title
Incidence of complications
Description
Nerve injury, Hematoma formation, LA toxicity, Intravascular injection.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged from 40 to 65 years old Both sexes. ASA I-II. Undergo hip replacement surgery. Body mass index (BMI) from 18 to 35 kg/m2. Exclusion Criteria: Patient refusal. Contraindication to regional anesthesia (bleeding disorder, use of any anticoagulants, local infection, etc. ) BMI > 35. Known allergy to local anesthetics. ASA III-IV. Patients with difficulty in evaluating their level of pain.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashraf Rady, M.D.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amr abdelnasser
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Anesthesia Department
City
Cairo
ZIP/Postal Code
1772
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29522966
Citation
Tulgar S, Selvi O, Senturk O, Ermis MN, Cubuk R, Ozer Z. Clinical experiences of ultrasound-guided lumbar erector spinae plane block for hip joint and proximal femur surgeries. J Clin Anesth. 2018 Jun;47:5-6. doi: 10.1016/j.jclinane.2018.02.014. Epub 2018 Mar 6. No abstract available.
Results Reference
background
PubMed Identifier
28372654
Citation
Ueshima H, Otake H. RETRACTED: Clinical experiences of ultrasound-guided erector spinae plane block for thoracic vertebra surgery. J Clin Anesth. 2017 May;38:137. doi: 10.1016/j.jclinane.2016.12.028. Epub 2017 Feb 17. No abstract available.
Results Reference
background
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
29913392
Citation
Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.
Results Reference
background

Learn more about this trial

Erector Spinae Plane Block for Postoperative Pain Control in Hip Replacement Surgeries

We'll reach out to this number within 24 hrs