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Erector Spinae Plan Block for Postoperative Analgesia

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Erector Spinae Plan Block
Oblique subcostal TAP
Sponsored by
Al Jedaani Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Erecror Spinae Plan Block, postoperative pain, Laparoscopic cholecystectomy

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 60 ASA I- II adult patients
  • 20-60 years old
  • elective laparoscopic cholecystectomy
  • Body mass index (BMI) less than 35
  • Port sites at or above thoracic T 10 dermatome

Exclusion Criteria:

  • Allergy to amino-amide local anesthetics
  • Presence of coagulopathy
  • Local skin infection at the needle puncture sites
  • Preoperative chronic dependence upon opioid and NSAID medications
  • Liver or renal insufficiency
  • History of psychiatric or neurological disease
  • Deafness
  • previous open surgery that need the conversion of laparoscopic to open surgery or manipulations more than expected with more tissue trauma
  • American Society of Anesthesiologists (ASA) above Class II

Sites / Locations

  • Al Jedaani group of hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Group I (Control)

Group II (ESP)

Group III(OSTAP)

Arm Description

ultrasound guided Bilateral Erector Spinae Plan Block using isotonic saline

ultrasound guided Bilateral Erector Spinae Plan Block with bupivacaine 0.25%

Ultrasound-guided bilateral oblique subcostal TAP block

Outcomes

Primary Outcome Measures

Morphine consumption
It was calculated as equivalent morphine dose to the opioid analgesia consumed

Secondary Outcome Measures

Quality of analgesia
comparing visual analog scores (VAS) every two hours after surgery
The intraoperative fentanyl
(µg) required during surgery
equivalent morphine dose in the recovery unit (PACU)
equivalent morphine dose in the recovery unit (PACU)
Erector spinae plan block complications
local anesthetic systemic toxicity, vascular injury, and intravascular injection of local anesthetic

Full Information

First Posted
December 29, 2017
Last Updated
December 21, 2018
Sponsor
Al Jedaani Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03398564
Brief Title
Erector Spinae Plan Block for Postoperative Analgesia
Official Title
Efficacy of Ultrasound-Guided Erector Spinae Plan Block on Postoperative Pain After Laparoscopic Cholecystectomy Under General Anesthesia. Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Al Jedaani Hospital

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
Laparoscopic cholecystectomy is a widely employed procedure in ambulatory surgery. Pain after laparoscopic cholecystectomy arises significantly from port site incisions in the anterior abdominal wall. Innervation of the anterior abdominal wall is segmentally supplied by pain afferents in the plane of fascia between transversus abdominis and the internal oblique muscles. Opioids analgesia is used to control postoperative pain, but it carries the risk of increased nausea and vomiting, ileus and sedation that may delay hospital discharge. Several techniques have been tried as.neuroaxial narcotics, intraperitoneal lavage of local anesthetic and transversus abdominis plan (TAP) block and successfully reduced opioid use and improve postoperative analgesia. The ultrasound-guided erector spinae plan(ESP) block is a recently described technique which produces reliable unilateral analgesia at thoraco-lumbar dermatomes. ESP block carries the advantages of being simple, safe, easily recognizable by ultrasound, and a catheter can be threaded to extend the duration of analgesia. Few case series reported the efficacy of (US)-guided ESP blocks in reducing postoperative pain and opioids consumption. Because of that, the investigators aimed to test the hypothesis that US-guided ESP blocks can decrease opioid consumption during the first 24 h after of laparoscopic cholecystectomy in comparison with the conventional systemic analgesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Erecror Spinae Plan Block, postoperative pain, Laparoscopic cholecystectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (Control)
Arm Type
Placebo Comparator
Arm Description
ultrasound guided Bilateral Erector Spinae Plan Block using isotonic saline
Arm Title
Group II (ESP)
Arm Type
Active Comparator
Arm Description
ultrasound guided Bilateral Erector Spinae Plan Block with bupivacaine 0.25%
Arm Title
Group III(OSTAP)
Arm Type
Active Comparator
Arm Description
Ultrasound-guided bilateral oblique subcostal TAP block
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plan Block
Intervention Description
The trocar site incision was done 15 minutes after the block in the three groups. The skin was disinfected with chlorhexidine solution, and the high-frequency transducer was isolated with a sterile disposable plastic cover and gel. The patient was placed in lateral position. A high-frequency linear ultrasound probe was placed longitudinally lateral to the T8 spinous process by 3 cm. After identification of the 3 muscles superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. The needle was introduced in a cephalo-caudal orientation. The needle tip was positioned fascial plane between rhomboid major and erector spinae muscles. Hydrodissection by 1-2 ml of normal saline to visualize the plan, then deposition of local anesthetic was done. A total of 20 mL of 0.25% bupivacaine was injected here. The same procedure was repeated on the other side.
Intervention Type
Procedure
Intervention Name(s)
Oblique subcostal TAP
Intervention Description
ultrasound-guided bilateral oblique subcostal TAP block with bupivacaine 0.25% (20ml on each side)
Primary Outcome Measure Information:
Title
Morphine consumption
Description
It was calculated as equivalent morphine dose to the opioid analgesia consumed
Time Frame
24 hours postoperatively.
Secondary Outcome Measure Information:
Title
Quality of analgesia
Description
comparing visual analog scores (VAS) every two hours after surgery
Time Frame
Every 2 hours for 24 hours postoperatively
Title
The intraoperative fentanyl
Description
(µg) required during surgery
Time Frame
2 hours
Title
equivalent morphine dose in the recovery unit (PACU)
Description
equivalent morphine dose in the recovery unit (PACU)
Time Frame
one hour
Title
Erector spinae plan block complications
Description
local anesthetic systemic toxicity, vascular injury, and intravascular injection of local anesthetic
Time Frame
24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 60 ASA I- II adult patients 20-60 years old elective laparoscopic cholecystectomy Body mass index (BMI) less than 35 Port sites at or above thoracic T 10 dermatome Exclusion Criteria: Allergy to amino-amide local anesthetics Presence of coagulopathy Local skin infection at the needle puncture sites Preoperative chronic dependence upon opioid and NSAID medications Liver or renal insufficiency History of psychiatric or neurological disease Deafness previous open surgery that need the conversion of laparoscopic to open surgery or manipulations more than expected with more tissue trauma American Society of Anesthesiologists (ASA) above Class II
Facility Information:
Facility Name
Al Jedaani group of hospitals
City
Jeddah
State/Province
Meccah
ZIP/Postal Code
21462/7500
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32843804
Citation
Ibrahim M. Erector Spinae Plane Block in Laparoscopic Cholecystectomy, Is There a Difference? A Randomized Controlled Trial. Anesth Essays Res. 2020 Jan-Mar;14(1):119-126. doi: 10.4103/aer.AER_144_19. Epub 2020 Feb 3.
Results Reference
derived

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Erector Spinae Plan Block for Postoperative Analgesia

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