Serratus Intercostal Plane Block,New Analgesia in Supraumbilical Surgery

Postoperative Pain Clinical Trial

— SIPB  

Official title:

Serratus Intercostal Plane Block in Supraumbilical Surgery: A Prospective Randomized Comparison

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04282291
• Other study ID #: PI 16-354
• Status: Completed
• Start date: February 18, 2016
• Est. completion date: August 30, 2019

Study information

• Verified date: February 2020
• Source: Hospital Medina del Campo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: August 30, 2019
• Est. primary completion date: August 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Injuries
• Abdominal Injury
• Analgesia
• Local Anaesthetic
• Postoperative Pain

Intervention

Procedure:
• fascial block as postoperative analgesia
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.

Drug:
• Morphine
The continuous (basal) dose

Device:
• PCA CADD Smith Medical pumps
perfusion

Locations

Country	Name	City	State
Spain	María Teresa Fernandez	Valladolid	Castilla Y León

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Medina del Campo

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Fernández Martín MT, López Álvarez 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. — View Citation

Fernández Martín MT, López Álvarez S, Pérez Herrero MA. Serratus-intercostal interfascial block as an opioid-saving strategy in supra-umbilical open surgery. Rev Esp Anestesiol Reanim. 2018 Oct;65(8):456-460. doi: 10.1016/j.redar.2018.03.007. Epub 2018 Ma — View Citation

Fernández Martín MT, López Álvarez S, Sanllorente Sebastián 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. — View 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. pii: rapm-2019-100384. doi: 10.1136/rapm-2019-100384. [Epub ahead of print] — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	analgesic rescue needed	intraoperative fentanyl and postoperative morphine	48 hours
Secondary	quality of recovery: QoR-15 questionnaire	using the scale of surgical recovery modified Postoperative Quality of Recovery Score; (The QoR-15:15 answers) that the patients filled in at 24 hours postoperatively. The QoR-15 questionnaire collected 9 parameters that valued the physical well-being (pain 2 items, Physical Comfort 4 Physical Independence 2) and 6 that valued the mental well-being (Psychological support 2, Emotional state 4). Each scored on an 11 point numerical rating (0-10)	24 hours