Erector Spinae Plan Block for Postoperative Analgesia

NCT03398564 | Completed DMC

• 1 other identifier: 1/12
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Erecror Spinae Plan Block; postoperative pain; Laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Morphine consumption

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

  24 hours postoperatively.

Secondary Outcomes (4)

• Quality of analgesia

  Every 2 hours for 24 hours postoperatively

• The intraoperative fentanyl

  2 hours

• equivalent morphine dose in the recovery unit (PACU)

  one hour

• Erector spinae plan block complications

  24 hours postoperative

Study Arms (3)

Group I (Control)

PLACEBO COMPARATOR

ultrasound guided Bilateral Erector Spinae Plan Block using isotonic saline

Procedure: Erector Spinae Plan Block

Group II (ESP)

ACTIVE COMPARATOR

ultrasound guided Bilateral Erector Spinae Plan Block with bupivacaine 0.25%

Procedure: Erector Spinae Plan Block

Group III(OSTAP)

ACTIVE COMPARATOR

Ultrasound-guided bilateral oblique subcostal TAP block

Procedure: Oblique subcostal TAP

Interventions

Erector Spinae Plan Block PROCEDURE

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.

Group I (Control); Group II (ESP)

Oblique subcostal TAP PROCEDURE

ultrasound-guided bilateral oblique subcostal TAP block with bupivacaine 0.25% (20ml on each side)

Group III(OSTAP)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Al Jedaani Hospital: lead

Study Sites (1)

Al Jedaani group of hospitals

Jeddah, Meccah, 21462/7500, Saudi Arabia

Location

Related Publications (1)

• 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.

  PMID: 32843804 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2017
• First Posted: January 12, 2018
• Study Start: January 10, 2018
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: December 26, 2018

Record last verified: 2018-10

Locations

SA (1)