Serratus Intercostal Plane Block,New Analgesia in Supraumbilical Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Pain, Analgesia, Local Anaesthetic, Abdominal Injury

Intervention / Treatment
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* Procedure: fascial block as postoperative analgesia
* Drug: Morphine
* Device: PCA CADD Smith Medical pumps


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SIPB (block)<br>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<br>* 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.<br>Device: PCA CADD Smith Medical pumps<br>* perfusion<br>|
| control (morphine)<br>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<br>* The continuous (basal) dose<br>Device: PCA CADD Smith Medical pumps<br>* perfusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic rescue needed | intraoperative fentanyl and postoperative morphine | 48 hours | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia, Abdominal surgery