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Clinical Trials/NCT03398564
NCT03398564
Completed
Not Applicable

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

Al Jedaani Hospital1 site in 1 country70 target enrollmentJanuary 10, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Al Jedaani Hospital
Enrollment
70
Locations
1
Primary Endpoint
Morphine consumption
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 10, 2018
End Date
November 30, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Al Jedaani Hospital
Responsible Party
Sponsor

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
  • 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

Outcomes

Primary Outcomes

Morphine consumption

Time Frame: 24 hours postoperatively.

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

Secondary Outcomes

  • Quality of analgesia(Every 2 hours for 24 hours postoperatively)
  • Erector spinae plan block complications(24 hours postoperative)
  • The intraoperative fentanyl(2 hours)
  • equivalent morphine dose in the recovery unit (PACU)(one hour)

Study Sites (1)

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