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Completed

NCT Number: NCT04282291

Serratus Intercostal Plane Block,New Analgesia in Supraumbilical Surgery

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.

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Key information

Conditions

Postoperative Pain Abdominal Injuries Abdominal Injury Agnosia Analgesia Local Anaesthetic Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

María Teresa Fernandez

Valladolid, Castille and León, 47008, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Morphine

Drug

The continuous (basal) dose

PCA CADD Smith Medical pumps

Device

perfusion

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

    Time frame: 24 postoperative hours

    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.

Secondary outcomes

  1. analgesic rescue needed

    Time frame: 48 hours

    intraoperative fentanyl and postoperative morphine

  2. quality of recovery: QoR-15 questionnaire

    Time frame: 24 hours

    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)

Sponsors and collaborators

Lead sponsor

Hospital Medina del Campo

Other

Registry information

Official study title

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

Acronym: SIPB

Important dates

Study start
2016
Primary completion
2016
Study completion
2019
First posted
Feb 24, 2020
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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