Clinical trial NCT04282291: Serratus Intercostal Plane Block,New Analgesia in Supraumbilical Surgery
Official title: Serratus Intercostal Plane Block in Supraumbilical Surgery: A Prospective Randomized Comparison
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Analgesia
Local Anaesthetic
Abdominal Injury
Keywords: Analgesia
Abdominal surgery
Lead sponsor: Hospital Medina del Campo
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.

Detailed description: The scientific evidence always supports the employment of a multimodal analgesic strategy, especially in procedures that generate a severe postoperative pain2, as media laparotomy or subcostal incision. The purpose is to not retard the patients' recovery and to avoid complications. The thoracic epidural analgesia is still the reference analgesic technique in open abdominal surgery7, although it is not exempt of limitations and complications. That is why, since the introduction of thoracic and abdominal fascial blocks, they have been part of the analgesic strategy, being an alternative to considerer instead the epidural.

Eligibility criteria: Inclusion Criteria:

* informed consent signature
* patients \>18 years old,

  . American Society of Anesthesiologist (ASA) risk scale \< IV,
* supraumbilical laparotomy (elective laparotomy or laparoscopy conversion)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: the local anesthetic in the serratus intercostal space at the eighth rib (SIPB)is an opioids sparing method in the perioperative time
timeFrame: 24 postoperative hours
Secondary outcomes:
measure: analgesic rescue needed
timeFrame: 48 hours
measure: quality of recovery: QoR-15 questionnaire
timeFrame: 24 hours
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: María Teresa Fernandez
state: Castilla Y León
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.