Serratus Intercostal Plane Block,New Analgesia in Supraumbilical Surgery

NCT04282291 | Completed DMC FDA Drug FDA Device

• 1 other identifier: PI 16-354
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The surgeries with upper abdominal wall incisions cause a severe pain and providing an adequate analgesia is an important challenge for the anesthesiologist. The serratus intercostal plane block (SIPB) has been already described as analgesic technique in open cholecystectomy. The aim of this study is to evaluate its analgesic efficacy in pain control, opioids consumption and recovery quality in upper abdominal surgeries. Methods: This blind, randomized controlled study was conducted on 102 patients undergoing open upper abdominal wall surgery under general anesthesia. All patients who received serratus intercostal plane block at the eighth rib as analgesic technique were included in group 0 (SIPB) and in Group 1 (control) those who received continuous intravenous morphine analgesia. In each group was evaluated pain scores in numeric verbal scale (NVS) and opioids consumption at 0,6,12,24 y 48h postoperative time. The quality of the postoperative recovery was evaluated with the modified Postoperative Quality of Recovery Score ( QoR-15 questionnaire) at 24h.

Conditions

Postoperative Pain; Analgesia; Local Anaesthetic; Abdominal Injury

Keywords

Analgesia; Abdominal surgery

Outcome Measures

Primary Outcomes (1)

• the local anesthetic in the serratus intercostal space at the eighth rib (SIPB)is an opioids sparing method in the perioperative time

  In a questionnaire designed for the study the pain scores were registered as main outcome, using verbal numeric scale (VNS) from 0(no pain at all) to 10 (worst imaginable pain) both at rest and the dynamic component (cough, deep breath, movement, so on). They were scored at 0, 6,12, 24 and 48 hours postoperatively.

  24 postoperative hours

Secondary Outcomes (2)

• analgesic rescue needed

  48 hours

• quality of recovery: QoR-15 questionnaire

  24 hours

Study Arms (2)

SIPB (block)

patients who underwent a modified BRILMA (intercostal rami block, middle axilary line) ultrasound-guided block with portable device with lineal probe and needle 80 mm. With the patient lying supine, the probe was placed in the sagittal plane of the middle axillary line to identify the aim thoracic structures. Under aseptic conditions, the needle was inserted in plane, caudo-craneal, to reach the fascial plane between the serratus anterior muscle and the external intercostal muscle at the eighth rib. A bolus dose of levobupivacaine 0.25% was administered, 3 ml of local anesthetic for each segment we want to block

Procedure: fascial block as postoperative analgesia; Device: PCA CADD Smith Medical pumps

control (morphine)

PCA (patient controlled analgesia) morphine was initiated immediately postoperatively using CADD Smith Medical pumps. All patients received PCA-morphine with the initial dose being 0.5-1 mg. The bolus dose was 0.01mg/kg mg morphine, with lockout time interval of 15 - 30 min, limiting of 8mg/hour, as the default program. The continuous (basal) dose was increased after 12-24 hours if using frequent demand doses or if pain not controlled and decreasing if no bolus was taken.

Drug: Morphine; Device: PCA CADD Smith Medical pumps

Interventions

fascial block as postoperative analgesia PROCEDURE

The tissue damage induced by the surgery generates a nociceptive pain which is accompanied by inflammatory mechanism (somatic pain), visceral and neuropathic pain, and why the treatment must be adapted to each surgical procedure. As the innervation of the upper abdominal wall depends mainly on the last intercostal nerves, the block of these nerves should be considered a good analgesic strategy to avoid the somatic pain. The placement of the local anesthetic in the serratus intercostal plane at the eighth rib (serratus intercostal plane block, SIPB) in the middle axillary line, managed to block the lateral and anterior cutaneous branches of the last intercostal nerves (T7-11). The results were satisfactory in the postoperative pain control of the patients with open cholecystectomy.

SIPB (block)

Morphine DRUG

The continuous (basal) dose

control (morphine)

PCA CADD Smith Medical pumps DEVICE

perfusion

SIPB (block); control (morphine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

After the informed consent signature the patients were randomly allocated into two groups (1:1 allocation ratio) using a computerized random number generator (http://www.randomization.com). Before the surgery, and with inclusion criteria checked, patients' demographic data were collected (age, sex, ASA risk scale).

You may qualify if:

• informed consent signature
• patients \>18 years old,
• American Society of Anesthesiologist (ASA) risk scale \< IV,
• supraumbilical laparotomy (elective laparotomy or laparoscopy conversion)

You may not qualify if:

• neurologic impairment,
• inability to give informed consent,
• used drugs allergy,
• contraindications to nerve block (coagulopathy, local infection at the site of the block)
• chronic pain treatment.

Sponsors & Collaborators

• Hospital Medina del Campo: lead

Study Sites (1)

María Teresa Fernandez

Valladolid, Castille and León, 47008, Spain

Location

Related Publications (5)

• Hamilton DL, Manickam BP. Is a Thoracic Fascial Plane Block the Answer to Upper Abdominal Wall Analgesia? Reg Anesth Pain Med. 2018 Nov;43(8):891-892. doi: 10.1097/AAP.0000000000000838. No abstract available.

  PMID: 30339615 BACKGROUND

• Fernandez MT, Lopez S, Ortigosa E. Reply to Dr Wang et al: serratus-intercostal block as opioids-saving strategy in supraumbilical surgery. Reg Anesth Pain Med. 2019 Feb 16:rapm-2019-100384. doi: 10.1136/rapm-2019-100384. Online ahead of print. No abstract available.

  PMID: 30772819 BACKGROUND

• Fernandez Martin MT, Lopez Alvarez S, Sanllorente Sebastian R. Serratus anterior plane block for upper abdominal incisions has been previously reported. Anaesth Intensive Care. 2019 Sep;47(5):472-473. doi: 10.1177/0310057X19870546. Epub 2019 Aug 25. No abstract available.

  PMID: 31446767 BACKGROUND

• Fernandez Martin MT, Lopez Alvarez S, Mozo Herrera G, Platero Burgos JJ. [Ultrasound-guided cutaneous intercostal branches nerves block: A good analgesic alternative for gallbladder open surgery]. Rev Esp Anestesiol Reanim. 2015 Dec;62(10):580-4. doi: 10.1016/j.redar.2015.02.011. Epub 2015 Apr 17. Spanish.

  PMID: 25896736 RESULT

• Fernandez Martin MT, Lopez Alvarez S, Perez Herrero MA. Serratus-intercostal interfascial block as an opioid-saving strategy in supra-umbilical open surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Oct;65(8):456-460. doi: 10.1016/j.redar.2018.03.007. Epub 2018 May 20. English, Spanish.

  PMID: 29789137 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Agnosia; Abdominal Injuries

Interventions

Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 102 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 24, 2020
• Study Start: February 18, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 30, 2019
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)