ESP Block Versus Wound Infiltration for Laminectomy
Primary Purpose
Pain, Postoperative, Opioid Use, Anesthesia, Local
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ESP block with saline
Wound infiltration with saline
ESP block with local anesthetic
Wound infiltration with local anesthetic
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring ESP block, Laminectomy, Wound infiltration
Eligibility Criteria
Inclusion Criteria:
-Planned 1 or 2 level surgical laminectomy
Exclusion Criteria:
- Allergy to local anesthetics
- Refusal of consent
- Uncompensated cardiopathies, nephropathies, liver disease or peripheral neuropathies
- Hemopathies that predispose to bleeding
- Gastrointestinal ulcer or bleeding
- Local infection
- Psychiatric or neurological disorders (except those attributed to primary disease for which intervention is planned) History of abuse (or use in the 24 hours prior to surgery) Alcohol addiction ASA > 3
Sites / Locations
- University Hospital of PadovaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ESP block
Wound infiltration
Arm Description
Patient will receive ESP block one level above surgery with ropivacaine 0.35% 20 ml per side Patient will receive preoperative wound infiltration with Saline 40 ml
Patient will receive ESP block one level above surgery with Saline 20 ml per side Patient will receive preoperative wound infiltration with ropivacaine 0.35% 40 ml
Outcomes
Primary Outcome Measures
Tramadol consumption
Postoperative tramadol consumption
Secondary Outcome Measures
Pain 0 hours
Pain measured with Numeric Rating Scale (0-10)
Pain 6 hours
Pain measured with Numeric Rating Scale (0-10)
Pain 12 hours
Pain measured with Numeric Rating Scale (0-10)
Pain 24 hours
Pain measured with Numeric Rating Scale (0-10)
Time to first analgesic requirement
Time in minutes to first analgesic requirement
Incidence of post operative nausea-vomiting
Incidence of post operative nausea-vomiting
Incidence of post operative respiratory depression
Incidence of post operative respiratory depression
Incidence of post operative pruritus
Incidence of post operative pruritus
Incidence of post operative motor block
Incidence of post operative motor block
Intraoperative opioid consumption
Intraoperative difference in consumption of fentanyl.
Evaluation of patient satisfaction
Evaluation of patient satisfaction of analgesia on a numeric rating score from 0-10.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05271331
Brief Title
ESP Block Versus Wound Infiltration for Laminectomy
Official Title
ESP Block Versus Wound Infiltration for Laminectomy: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
May 20, 2023 (Anticipated)
Study Completion Date
May 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Padova
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
Spinal surgery is often burdened by perioperative pain and its treatment presently represents a challenge for anesthetists. An inadequate intra and postoperative analgesic therapy leads to a delay in the mobilization of the patients, prolonged hospital stay and thromboembolic complications, as well as the onset of chronic pain syndromes . Effective pain treatment can help improve surgical outcome for patients undergoing spinal surgery. From the pathophysiological point of view pain in vertebral surgery can originate from different anatomical structures: vertebrae, discs, ligaments, dura mater, facet joints, muscles and skin-subcutis. The terminal innervation of these tissues originate from the dorsal branches of the spinal nerves, and this represents a target a multimodal approach to perioperative analgesia in vertebral surgery. Systemically administered drugs such as NSAIDs, opioids, ketamine, intravenous lidocaine could benefit from the addition of locoregional therapies such as neuraxial blocks (anesthesia peridural or subarachnoid) or as shown more recently by other anesthesia techniques locoregional ultrasound-guided In recent years the anesthesiological interest has focused on the Erector Spinae Plane Block (ESPB). First described by Forero et al, it is a paraspinal interfascial block targeting the dorsal and ventral branches of the spinal nerves just after their emergence from the spinal cord. In the ultrasound-guided technique the local anesthetic is injected between the deep fascia of the muscle itself and the transverse processes of the vertebrae at the level interested. The aim of this study is to evaluate the efficacy of ESPB when compared to wound infiltration in patients undergoing laminectomy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Opioid Use, Anesthesia, Local, Surgery
Keywords
ESP block, Laminectomy, Wound infiltration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Both arms will receive the same treatment (Wound infiltration and ESP block) after general anesthesia induction (Participant masked to intervention) Drugs will be prepared after randomization by a physician not involved in the care of the patients and not involved in the study, and labelled as WOUND INFILTRATION and ESP block. One syringe will contain local anesthetic, the other normal saline (Care Provider masked to intervention, Investigator masked to intervention) Outcome assessor will be not involved in other part of the study and will be not aware of the intervention (Outcome assessor masked to intervention)
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ESP block
Arm Type
Experimental
Arm Description
Patient will receive ESP block one level above surgery with ropivacaine 0.35% 20 ml per side Patient will receive preoperative wound infiltration with Saline 40 ml
Arm Title
Wound infiltration
Arm Type
Active Comparator
Arm Description
Patient will receive ESP block one level above surgery with Saline 20 ml per side Patient will receive preoperative wound infiltration with ropivacaine 0.35% 40 ml
Intervention Type
Drug
Intervention Name(s)
ESP block with saline
Other Intervention Name(s)
Erector spinae plane block
Intervention Description
Bilateral ultrasound guided injection of saline in the erector spinae plane (below erector spinae plane muscle group and above the transverse process of the vertebra)
Intervention Type
Drug
Intervention Name(s)
Wound infiltration with saline
Intervention Description
Blinded injection of saline in the skin, subcutaneous tissue and muscles at the site of surgical incision
Intervention Type
Drug
Intervention Name(s)
ESP block with local anesthetic
Other Intervention Name(s)
Erector spinae plane block
Intervention Description
Bilateral ultrasound guided injection of local anesthetic (ropivacaine 0.35%, 40ml) in the erector spinae plane (below erector spinae plane muscle group and above the tranverse process of the vertebra)
Intervention Type
Drug
Intervention Name(s)
Wound infiltration with local anesthetic
Intervention Description
Blinded injection of local anestetic (ropivacaine 0.35%, 40ml) in the skin, subcutaneous tissue and muscles at the site of surgical incision.
Primary Outcome Measure Information:
Title
Tramadol consumption
Description
Postoperative tramadol consumption
Time Frame
Evaluated from extubation for the first post-operative 24 hours
Secondary Outcome Measure Information:
Title
Pain 0 hours
Description
Pain measured with Numeric Rating Scale (0-10)
Time Frame
At extubation
Title
Pain 6 hours
Description
Pain measured with Numeric Rating Scale (0-10)
Time Frame
6 hours after end of surgery
Title
Pain 12 hours
Description
Pain measured with Numeric Rating Scale (0-10)
Time Frame
12 hours after end of surgery
Title
Pain 24 hours
Description
Pain measured with Numeric Rating Scale (0-10)
Time Frame
24 hours after end of surgery
Title
Time to first analgesic requirement
Description
Time in minutes to first analgesic requirement
Time Frame
24 hours after end of surgery
Title
Incidence of post operative nausea-vomiting
Description
Incidence of post operative nausea-vomiting
Time Frame
24 hours after end of surgery
Title
Incidence of post operative respiratory depression
Description
Incidence of post operative respiratory depression
Time Frame
24 hours after end of surgery
Title
Incidence of post operative pruritus
Description
Incidence of post operative pruritus
Time Frame
24 hours after end of surgery
Title
Incidence of post operative motor block
Description
Incidence of post operative motor block
Time Frame
24 hours after end of surgery
Title
Intraoperative opioid consumption
Description
Intraoperative difference in consumption of fentanyl.
Time Frame
At extubation
Title
Evaluation of patient satisfaction
Description
Evaluation of patient satisfaction of analgesia on a numeric rating score from 0-10.
Time Frame
24 hours after end of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-Planned 1 or 2 level surgical laminectomy
Exclusion Criteria:
Allergy to local anesthetics
Refusal of consent
Uncompensated cardiopathies, nephropathies, liver disease or peripheral neuropathies
Hemopathies that predispose to bleeding
Gastrointestinal ulcer or bleeding
Local infection
Psychiatric or neurological disorders (except those attributed to primary disease for which intervention is planned) History of abuse (or use in the 24 hours prior to surgery) Alcohol addiction ASA > 3
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro De Cassai
Phone
+390498213090
Email
alessandro.decassai@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Federico Geraldini, MD
Organizational Affiliation
University Hospital of Padova
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Padova
City
Padova
State/Province
Veneto
ZIP/Postal Code
35127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro De Cassai, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD will be shared on reasonable request after ethical committee request examination
Learn more about this trial
ESP Block Versus Wound Infiltration for Laminectomy
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