Clinical trial NCT03398564: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Erecror Spinae Plan Block
postoperative pain
Laparoscopic cholecystectomy
Lead sponsor: Al Jedaani Hospital
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Morphine consumption
timeFrame: 24 hours postoperatively.
Secondary outcomes:
measure: Quality of analgesia
timeFrame: Every 2 hours for 24 hours postoperatively
measure: The intraoperative fentanyl
timeFrame: 2 hours
measure: equivalent morphine dose in the recovery unit (PACU)
timeFrame: one hour
measure: Erector spinae plan block complications
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: Al Jedaani group of hospitals
state: Meccah
Study officials:
References:
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.