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Serratus Intercostal Plane Block,New Analgesia in Supraumbilical Surgery (SIPB)

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ClinicalTrials.gov Identifier: NCT04282291
Recruitment Status : Completed
First Posted : February 24, 2020
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
María Teresa Fernandez, Hospital Medina del Campo

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.


Condition or disease Intervention/treatment
Postoperative Pain Analgesia Local Anaesthetic Abdominal Injury Procedure: fascial block as postoperative analgesia Drug: Morphine Device: PCA CADD Smith Medical pumps

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 105 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 102 Years
Official Title: Serratus Intercostal Plane Block in Supraumbilical Surgery: A Prospective Randomized Comparison
Actual Study Start Date : February 18, 2016
Actual Primary Completion Date : August 1, 2016
Actual Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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.

Device: PCA CADD Smith Medical pumps
perfusion

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
The continuous (basal) dose

Device: PCA CADD Smith Medical pumps
perfusion




Primary Outcome Measures :
  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 Outcome Measures :
  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)




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282291


Locations
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Spain
María Teresa Fernandez
Valladolid, Castilla Y León, Spain, 47008
Sponsors and Collaborators
Hospital Medina del Campo
Publications of Results:
Other Publications:
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Responsible Party: María Teresa Fernandez, Principal Investigator, Hospital Medina del Campo
ClinicalTrials.gov Identifier: NCT04282291    
Other Study ID Numbers: PI 16-354
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by María Teresa Fernandez, Hospital Medina del Campo:
Analgesia
Abdominal surgery
Additional relevant MeSH terms:
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Abdominal Injuries
Wounds and Injuries
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents