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

H

Hospital Medina del Campo

Status

Completed

Conditions

Postoperative Pain
Abdominal Injury
Analgesia
Local Anaesthetic

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT04282291
PI 16-354

Details and patient eligibility

About

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.

Full 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.

Enrollment

105 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

105 participants in 2 patient groups

SIPB (block)
Description:
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
Treatment:
Procedure: fascial block as postoperative analgesia
Device: PCA CADD Smith Medical pumps
control (morphine)
Description:
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.
Treatment:
Drug: Morphine
Device: PCA CADD Smith Medical pumps

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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