Postoperative PainSIPBNCT04282291
Serratus Intercostal Plane Block,New Analgesia in Supraumbilical Surgery
An observational study of Postoperative Pain and Analgesia, run by Hospital Medina del Campo at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Analgesia, Local Anaesthetic
- What is being tested?
- fascial block as postoperative analgesia, Morphine and PCA CADD Smith Medical pumps
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 105 participants
- Where
- 1 siteSpain
- Study dates
- 18 Feb 2016to 30 Aug 2019
- How long will I take part?
- 102 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- informed consent signature
- patients >18 years old,
- . American Society of Anesthesiologist (ASA) risk scale < IV,
- supraumbilical laparotomy (elective laparotomy or laparoscopy conversion)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Serratus Intercostal Plane Block in Supraumbilical Surgery: A Prospective Randomized Comparison
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.
Read the 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.
- Conditions
- Postoperative Pain, Analgesia, Local Anaesthetic, Abdominal Injury
- Being tested
- fascial block as postoperative analgesia, Morphine, PCA CADD Smith Medical pumps
- Keywords
- Analgesia, Abdominal surgery
- Medical subject headings
- Pain, Postoperative, Agnosia, Abdominal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fascial block as postoperative analgesiaProcedure or surgery
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.
MorphineDrug
The continuous (basal) dose
PCA CADD Smith Medical pumpsDevice
perfusion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: fascial block as postoperative analgesia; Device: PCA CADD Smith Medical pumps | |
| 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. Receives: Drug: Morphine; Device: PCA CADD Smith Medical pumps |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 postoperative hours
Secondary outcomes (2)
analgesic rescue needed
intraoperative fentanyl and postoperative morphine
Measured: 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)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start18 Feb 2016
- Primary completion1 Aug 2016
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
- Target duration
- 102 Years
Sponsor and investigators
- Lead sponsor
- Hospital Medina del Campo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Teresa Fernandez, Hospital Medina del Campo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282291
- Sponsor's protocol ID
- PI 16-354
- Acronym
- SIPB
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2020
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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. No abstract available.
PubMed 30339615Fernandez 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:rapm-2019-100384. doi: 10.1136/rapm-2019-100384. Online ahead of print. No abstract available.
PubMed 30772819Fernandez Martin MT, Lopez Alvarez S, Sanllorente Sebastian 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. No abstract available.
PubMed 31446767Fernandez Martin MT, Lopez Alvarez 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: 10.1016/j.redar.2015.02.011. Epub 2015 Apr 17. Spanish.
PubMed 25896736Fernandez Martin MT, Lopez Alvarez S, Perez Herrero MA. Serratus-intercostal interfascial block as an opioid-saving strategy in supra-umbilical open surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Oct;65(8):456-460. doi: 10.1016/j.redar.2018.03.007. Epub 2018 May 20. English, Spanish.
PubMed 29789137
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serratus Intercostal Plane Block in Supraumbilical Surgery: A Prospective Randomized Comparison
- ClinicalTrials.gov ID
- NCT04282291
- Acronym / sponsor ID
- SIPB / PI 16-354
- Conditions
- Postoperative Pain, Analgesia, Local Anaesthetic, Abdominal Injury
- Keywords
- Analgesia, Abdominal surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Hospital Medina del CampoUniversity, hospital or other
- Study start
- 18 Feb 2016 (actual)
- Primary completion
- 1 Aug 2016 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 102 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIPB (block) | – | Procedure: fascial block as postoperative analgesia, Device: PCA CADD Smith Medical pumpspatients 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 |
| control (morphine) | – | Drug: Morphine, Device: PCA CADD Smith Medical pumpsPCA (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- informed consent signature
- patients >18 years old,
- . American Society of Anesthesiologist (ASA) risk scale < IV,
- supraumbilical laparotomy (elective laparotomy or laparoscopy conversion)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fascial block as postoperative analgesiaThe 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. | Procedure or surgery | SIPB (block) |
| MorphineThe continuous (basal) dose | Drug | control (morphine) |
| PCA CADD Smith Medical pumpsperfusion | Device | SIPB (block), control (morphine) |
Primary outcome
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.
2 secondary outcomes
analgesic rescue needed
Time frame: 48 hours
quality of recovery: QoR-15 questionnaire
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Background: PubMed 30339615Hamilton 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. No abstract available.
- Background: PubMed 30772819Fernandez 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:rapm-2019-100384. doi: 10.1136/rapm-2019-100384. Online ahead of print. No abstract available.
- Background: PubMed 31446767Fernandez Martin MT, Lopez Alvarez S, Sanllorente Sebastian 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. No abstract available.
- Results publication: PubMed 25896736Fernandez Martin MT, Lopez Alvarez 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: 10.1016/j.redar.2015.02.011. Epub 2015 Apr 17. Spanish.
- Results publication: PubMed 29789137Fernandez Martin MT, Lopez Alvarez S, Perez Herrero MA. Serratus-intercostal interfascial block as an opioid-saving strategy in supra-umbilical open surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Oct;65(8):456-460. doi: 10.1016/j.redar.2018.03.007. Epub 2018 May 20. English, Spanish.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Analgesia, run by Hospital Medina del Campo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04282291, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.