Erector Spinae Plan Block for Postoperative Analgesia

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: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Erector Spinae Plan Block; Procedure: Oblique subcostal TAP

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Morphine consumption	It was calculated as equivalent morphine dose to the opioid analgesia consumed	24 hours postoperatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of analgesia	comparing visual analog scores (VAS) every two hours after surgery	Every 2 hours for 24 hours postoperatively
The intraoperative fentanyl	(µg) required during surgery	2 hours
equivalent morphine dose in the recovery unit (PACU)	equivalent morphine dose in the recovery unit (PACU)	one hour
Erector spinae plan block complications	local anesthetic systemic toxicity, vascular injury, and intravascular injection of local anesthetic	24 hours postoperative

Collaborators and Investigators

• Sponsor: Al Jedaani Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2018
• Primary Completion (ACTUAL): November 30, 2018
• Study Completion (ACTUAL): November 30, 2018

Study Registration Dates

• First Submitted: December 29, 2017
• First Submitted That Met QC Criteria: January 6, 2018
• First Posted (ACTUAL): January 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 26, 2018
• Last Update Submitted That Met QC Criteria: December 21, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: postoperative pain; Laparoscopic cholecystectomy; Erecror Spinae Plan Block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID 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