Erector Spinae Plan Block for Postoperative Analgesia

December 21, 2018 updated by: Al Jedaani Hospital

Efficacy of Ultrasound-Guided Erector Spinae Plan Block on Postoperative Pain After Laparoscopic Cholecystectomy Under General Anesthesia. Randomized, Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Meccah
      • Jeddah, Meccah, Saudi Arabia, 21462/7500
        • Al Jedaani group of hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Group I (Control)
ultrasound guided Bilateral Erector Spinae Plan Block using isotonic saline
Procedure: Erector Spinae Plan Block
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.
ACTIVE_COMPARATOR: Group II (ESP)
ultrasound guided Bilateral Erector Spinae Plan Block with bupivacaine 0.25%
Procedure: Erector Spinae Plan Block
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.
ACTIVE_COMPARATOR: Group III(OSTAP)
Ultrasound-guided bilateral oblique subcostal TAP block
Procedure: Oblique subcostal TAP
ultrasound-guided bilateral oblique subcostal TAP block with bupivacaine 0.25% (20ml on each side)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Morphine consumption
Time Frame: 24 hours postoperatively.
It was calculated as equivalent morphine dose to the opioid analgesia consumed
24 hours postoperatively.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of analgesia
Time Frame: Every 2 hours for 24 hours postoperatively
comparing visual analog scores (VAS) every two hours after surgery
Every 2 hours for 24 hours postoperatively
The intraoperative fentanyl
Time Frame: 2 hours
(µg) required during surgery
2 hours
equivalent morphine dose in the recovery unit (PACU)
Time Frame: one hour
equivalent morphine dose in the recovery unit (PACU)
one hour
Erector spinae plan block complications
Time Frame: 24 hours postoperative
local anesthetic systemic toxicity, vascular injury, and intravascular injection of local anesthetic
24 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Al Jedaani Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1/12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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