Abdominal HysterectomyNCT04724564
Correlation of Different Time Measurements of the Surgical PLETH Index With Postoperative Pain
An observational study of Abdominal Hysterectomy, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
Despite the major progress in anesthetic techniques, postoperative pain is still considered a major problem during practice. (1-3). Leading to many co-morbidities, one to two-thirds of patients will suffer postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Abdominal Hysterectomy
- What is being tested?
- THE SURGICAL PLETH INDEX
- How many people
- 99 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 1 Dec 2021
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients admitted in Fayoum uniersity hospital who are candidates for elective abdominal hysterectomy under general anesthesia and their age range from 18-65
Who may be able to join
- elective abdominal hysterectomy under general anesthesia and their age range from 18-65
Who cannot join
- an age <18 years
- significant dysrhythmia like AF or atrioventricular block more than1st degree
- patient with a pacemaker
- treatment with vasoactive medications, and any intraoperative treatment with clonidine, beta-receptor agonists or antagonists, or any other drug that can affect the sympathovagal balance.
- Patients receiving neuraxial anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation of Different Time Measurements of the Surgical PLETH Index With Postoperative Pain; a Prospective Observational Study
Despite the major progress in anesthetic techniques, postoperative pain is still considered a major problem during practice. (1-3). Leading to many co-morbidities, one to two-thirds of patients will suffer postoperative pain. These co-morbidities can include; pulmonary complications, cardiac complications, and delirium(4). Numerous risk factors are associated with the emergence of postoperative pain, including; younger age, female sex, preoperative pain, and extensive surgical procedure. The severity of postoperative pain may vary among patients undergoing the same operation (5-10).
Many techniques have been evolved to monitor nociception and predict postoperative pain intensity; one of the most recent techniques is the surgical pleth index (SPI)(11).SPI is a noninvasive dimensionless score; its value is obtained from heartbeat interval and pulse wave amplitude monitored by pulse oximetry probe.SPI reflects the sympathetic response of the patient to the surgical stimuli(12-13). It was reported that SPI is better than other parameters like heart rate and blood pressure for detecting the balance between nociceptor activation and analgesia(14-15), and its value is correlated with the severity of postoperative pain. SPI values range from 0 to 100, and higher values indicate strong surgical stimulus (16). SPI can be used as a guide for intraoperative analgesia; hence, it can be a valuable tool to assess the analgesic requirement and limit opioid consumption, both preoperative and postoperative(17).
Read more
Several studies have been performed to predict the severity of postoperative pain using SPI in adults and children (16,18). It was also used successfully to expect a hemodynamic response to tracheal intubation and skin incision (19) and monitor nerve block success. (20).
However, since SPI has emerged, the most sensitive cut-off value that correlates well with postoperative pain severity remained debatable. Recent studies reported a value of 30 as a cut-off value of SPI. (21). On the other hand, the time of measurement to rely on was debatable. Most studies recommended that a measure of SPI before recovery can be used. However, a more recent study suggested that SPI response to surgical incision is highly correlated with postoperative pain and opioid consumption (18). Based on these data, we hypothesized that both measurements are correlated with postoperative pain and aimed to test which measure is more correlated.
Read the detailed description
The current study's objective is to determine the optimum time to measure intraoperative SPI, which correlates better with postoperative pain.
Methods:
The study will be performed at Fayoum university hospital after the local institutional ethics committee and local institutional review board's approval. The study design will be a prospective observational study.A total of 99 patients scheduled for elective abdominal hysterectomy under general anesthesia and their age range from 18-65 will be included in this trial.
Exclusion criteria included; an age <18 years, significant dysrhythmia like AF or atrioventricular block more than1st degree, patient with a pacemaker,treatment with vasoactive medications, and any intraoperative t reatment with clonidine, beta-receptor agonists or antagonists, or anyother drug that can affect the sympathovagal balance.patients receiving neuraxial anesthesia will also be excluded.
Anesthesia and pain management:
All patients will fast 6 hours for solid food and 2 hours for clear fluids before the operation. After arriving the operating room, standard monitoring (Pulse oximetry, Noninvasive blood pressure, and Electrocardiogram)will be applied and continued all over the operation. An 18G peripheral cannula will be inserted.All patients will be pre-oxygenated with 100% O2 and premedicated with 0.03 mg/kg IV midazolam and10 mg metoclopramide. Intravenous induction of anesthesia will be performed using2mg/kg propofol, l-2µgm/kg fentanyl and0.5mg/kg atracurium. All patients will receive 1gm paracetamol IV as intraoperative supplementary analgesia just after the induction. An endotracheal tube will be inserted for all patients. Mechanical ventilation will be adjusted as volume controlled ventilation with 5cmH2oaiming to maintain end-tidalCo2 pressure of 30 to 40 mmHg by a mixture of O2with fiO20.5and air. Anesthesia will be maintained with isoflurane. SPI will be recorded 5 min after skin incision and 10 min before recovery. Using anesthesia machine( carestatation 650 l GE.3.4.2019) After recovery,Upon ability of communication, all patients will be asked to quantify their level of pain on a 0 - 10 point numeric rating scale (NRS) with (0= no pain, 1-3 mild, 4-5 moderate and 6-10 severe) three scores will be obtained with 5 minutes intervals and the highest pain score of the three will be recorded for further analysis (without affection of the routine pain management).
All patients will be transferred to the obstetrics ward when they reach a modified Aldrete score ≥9. During the first 24 hours, all patients will receive IV paracetamol 1 g every 8 hours for postoperative analgesia according to the obstetric department protocol. In addition to intravenous tramadol through PCA
(concentration of 4 mg/ml) with 20 mg dose, 10 minutes lockout interval, and one hour limit of 50 mg.
Measured parameters:
SPI at 5 minutes after skin incision and 10 minutes before recovery, the highest pain score (NRS) in the PACU,total opioid consumption during the first 24 hours, Nausea and vomiting (will be assessed on a scale: 0 = no symptoms, 1 = only nausea, 2 = nausea and/vomiting), Respiratory depression (will be defined as respiratory rate lower than 10), Sedation (will be assessed using a sedation score where 0 = awake and alert, 1 = quietly awake, 2 = asleep but easily arousable, 3=deep sleep, responding to a painful stimulus) All these data will be collected by a separate anesthesiologist who will be blinded with the study.
The primary outcome is to determine which SPI measurement is more correlated with postoperative pain. The secondary outcomes is to evaluate the correlation between the SPI measurements and opioid consumption in the first postoperative 24 hours and to define the cut-off value of SPI measurements
- Conditions
- Abdominal Hysterectomy
- Being tested
- THE SURGICAL PLETH INDEX
- Keywords
- Hysterectomy, Analgesic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THE SURGICAL PLETH INDEXDiagnostic test
CORRELATION OF DIFFERENT TIME MEASUREMENTS OF THE SURGICAL PLETH INDEX WITH POSTOPERATIVE PAIN
What is being measured
The primary outcome is the main question the study is designed to answer.
which SPI measurement is more correlated with postoperative pain
The primary outcome is to determine which SPI measurement is more correlated with postoperative pain
Measured: SPI at 5 minutes after skin incision and 10 minutes before recovery
Secondary outcomes (2)
the correlation between the SPI measurements and opioid consumption
the correlation between the SPI measurements and opioid consumption
Measured: the first postoperative 24 hours
the cut-off value of SPI measurements
to define the cut-off value of SPI measurements
Measured: SPI at 5 minutes after skin incision and 10 minutes before recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Feb 2021
- Primary completion15 Nov 2021
- Study completion1 Dec 2021
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 Abdominal HysterectomyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Hamed, Fayoum University Hospital
- Investigators
- Mohamed A Hamed, MD, Principal investigator, Fayoum University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724564
- Sponsor's protocol ID
- M 703
- Status last verified
- Jan 2022
- First submitted
- 21 Jan 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plane to share IPD
Publications
Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
PubMed 23392233Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
PubMed 26509324Persson AK, Dyrehag LE, Akeson J. Prediction of Postoperative Pain From Electrical Pain Thresholds After Laparoscopic Cholecystectomy. Clin J Pain. 2017 Feb;33(2):126-131. doi: 10.1097/AJP.0000000000000394.
PubMed 27258997Persson AKM, Akeson J. Prediction of Acute Postoperative Pain from Assessment of Pain Associated With Venous Cannulation. Pain Pract. 2019 Feb;19(2):158-167. doi: 10.1111/papr.12729. Epub 2018 Nov 5.
PubMed 30269418Jung K, Park MH, Kim DK, Kim BJ. Prediction of Postoperative Pain and Opioid Consumption Using Intraoperative Surgical Pleth Index After Surgical Incision: An Observational Study. J Pain Res. 2020 Nov 6;13:2815-2824. doi: 10.2147/JPR.S264101. eCollection 2020.
PubMed 33192089
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Different Time Measurements of the Surgical PLETH Index With Postoperative Pain; a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04724564
- Acronym / sponsor ID
- M 703
- Conditions
- Abdominal Hysterectomy
- Keywords
- Hysterectomy, Analgesic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 26 Jan 2021 (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.
Despite the major progress in anesthetic techniques, postoperative pain is still considered a major problem during practice. (1-3). Leading to many co-morbidities, one to two-thirds of patients will suffer postoperative pain. These co-morbidities can include; pulmonary complications, cardiac complications, and delirium(4). Numerous risk factors are associated with the emergence of postoperative pain, including; younger age, female sex, preoperative pain, and extensive surgical procedure. The severity of postoperative pain may vary among patients undergoing the same operation (5-10).
Many techniques have been evolved to monitor nociception and predict postoperative pain intensity; one of the most recent techniques is the surgical pleth index (SPI)(11).SPI is a noninvasive dimensionless score; its value is obtained from heartbeat interval and pulse wave amplitude monitored by pulse oximetry probe.SPI reflects the sympathetic response of the patient to the surgical stimuli(12-13). It was reported that SPI is better than other parameters like heart rate and blood pressure for detecting the balance between nociceptor activation and analgesia(14-15), and its value is correlated with the severity of postoperative pain. SPI values range from 0 to 100, and higher values indicate strong surgical stimulus (16). SPI can be used as a guide for intraoperative analgesia; hence, it can be a valuable tool to assess the analgesic requirement and limit opioid consumption, both preoperative and postoperative(17).
Several studies have been performed to predict the severity of postoperative pain using SPI in adults and children (16,18). It was also used successfully to expect a hemodynamic response to tracheal intubation and skin incision (19) and monitor nerve block success. (20).
However, since SPI has emerged, the most sensitive cut-off value that correlates well with postoperative pain severity remained debatable. Recent studies reported a value of 30 as a cut-off value of SPI. (21). On the other hand, the time of measurement to rely on was debatable. Most studies recommended that a measure of SPI before recovery can be used. However, a more recent study suggested that SPI response to surgical incision is highly correlated with postoperative pain and opioid consumption (18). Based on these data, we hypothesized that both measurements are correlated with postoperative pain and aimed to test which measure is more correlated.
Detailed description
The current study's objective is to determine the optimum time to measure intraoperative SPI, which correlates better with postoperative pain.
Methods:
The study will be performed at Fayoum university hospital after the local institutional ethics committee and local institutional review board's approval. The study design will be a prospective observational study.A total of 99 patients scheduled for elective abdominal hysterectomy under general anesthesia and their age range from 18-65 will be included in this trial.
Exclusion criteria included; an age <18 years, significant dysrhythmia like AF or atrioventricular block more than1st degree, patient with a pacemaker,treatment with vasoactive medications, and any intraoperative t reatment with clonidine, beta-receptor agonists or antagonists, or anyother drug that can affect the sympathovagal balance.patients receiving neuraxial anesthesia will also be excluded.
Anesthesia and pain management:
All patients will fast 6 hours for solid food and 2 hours for clear fluids before the operation. After arriving the operating room, standard monitoring (Pulse oximetry, Noninvasive blood pressure, and Electrocardiogram)will be applied and continued all over the operation. An 18G peripheral cannula will be inserted.All patients will be pre-oxygenated with 100% O2 and premedicated with 0.03 mg/kg IV midazolam and10 mg metoclopramide. Intravenous induction of anesthesia will be performed using2mg/kg propofol, l-2µgm/kg fentanyl and0.5mg/kg atracurium. All patients will receive 1gm paracetamol IV as intraoperative supplementary analgesia just after the induction. An endotracheal tube will be inserted for all patients. Mechanical ventilation will be adjusted as volume controlled ventilation with 5cmH2oaiming to maintain end-tidalCo2 pressure of 30 to 40 mmHg by a mixture of O2with fiO20.5and air. Anesthesia will be maintained with isoflurane. SPI will be recorded 5 min after skin incision and 10 min before recovery. Using anesthesia machine( carestatation 650 l GE.3.4.2019) After recovery,Upon ability of communication, all patients will be asked to quantify their level of pain on a 0 - 10 point numeric rating scale (NRS) with (0= no pain, 1-3 mild, 4-5 moderate and 6-10 severe) three scores will be obtained with 5 minutes intervals and the highest pain score of the three will be recorded for further analysis (without affection of the routine pain management).
All patients will be transferred to the obstetrics ward when they reach a modified Aldrete score ≥9. During the first 24 hours, all patients will receive IV paracetamol 1 g every 8 hours for postoperative analgesia according to the obstetric department protocol. In addition to intravenous tramadol through PCA
(concentration of 4 mg/ml) with 20 mg dose, 10 minutes lockout interval, and one hour limit of 50 mg.
Measured parameters:
SPI at 5 minutes after skin incision and 10 minutes before recovery, the highest pain score (NRS) in the PACU,total opioid consumption during the first 24 hours, Nausea and vomiting (will be assessed on a scale: 0 = no symptoms, 1 = only nausea, 2 = nausea and/vomiting), Respiratory depression (will be defined as respiratory rate lower than 10), Sedation (will be assessed using a sedation score where 0 = awake and alert, 1 = quietly awake, 2 = asleep but easily arousable, 3=deep sleep, responding to a painful stimulus) All these data will be collected by a separate anesthesiologist who will be blinded with the study.
The primary outcome is to determine which SPI measurement is more correlated with postoperative pain. The secondary outcomes is to evaluate the correlation between the SPI measurements and opioid consumption in the first postoperative 24 hours and to define the cut-off value of SPI measurements
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted in Fayoum uniersity hospital who are candidates for elective abdominal hysterectomy under general anesthesia and their age range from 18-65
Key inclusion criteria (1 listed)
- elective abdominal hysterectomy under general anesthesia and their age range from 18-65
Key exclusion criteria (5 listed)
- an age <18 years
- significant dysrhythmia like AF or atrioventricular block more than1st degree
- patient with a pacemaker
- treatment with vasoactive medications, and any intraoperative treatment with clonidine, beta-receptor agonists or antagonists, or any other drug that can affect the sympathovagal balance.
- Patients receiving neuraxial anesthesia
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 |
|---|---|---|
| THE SURGICAL PLETH INDEXCORRELATION OF DIFFERENT TIME MEASUREMENTS OF THE SURGICAL PLETH INDEX WITH POSTOPERATIVE PAIN | Diagnostic test | – |
Primary outcome
which SPI measurement is more correlated with postoperative pain
Time frame: SPI at 5 minutes after skin incision and 10 minutes before recovery
The primary outcome is to determine which SPI measurement is more correlated with postoperative pain
2 secondary outcomes
the correlation between the SPI measurements and opioid consumption
Time frame: the first postoperative 24 hours
the cut-off value of SPI measurements
Time frame: SPI at 5 minutes after skin incision and 10 minutes before recovery
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 19 Jan 2022.
- Background: PubMed 23392233Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
- Background: PubMed 26509324Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
- Background: PubMed 27258997Persson AK, Dyrehag LE, Akeson J. Prediction of Postoperative Pain From Electrical Pain Thresholds After Laparoscopic Cholecystectomy. Clin J Pain. 2017 Feb;33(2):126-131. doi: 10.1097/AJP.0000000000000394.
- Background: PubMed 30269418Persson AKM, Akeson J. Prediction of Acute Postoperative Pain from Assessment of Pain Associated With Venous Cannulation. Pain Pract. 2019 Feb;19(2):158-167. doi: 10.1111/papr.12729. Epub 2018 Nov 5.
- Background: PubMed 33192089Jung K, Park MH, Kim DK, Kim BJ. Prediction of Postoperative Pain and Opioid Consumption Using Intraoperative Surgical Pleth Index After Surgical Incision: An Observational Study. J Pain Res. 2020 Nov 6;13:2815-2824. doi: 10.2147/JPR.S264101. eCollection 2020.
- Individual participant dataSharing planned: No. No plane to share IPD
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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.
Mohamed A Hamed, MD principal investigator
Fayoum University Hospital
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 Abdominal Hysterectomy, run by Fayoum University Hospital at 1 site in Egypt.
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 1 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 19 Jan 2022. 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 Egypt. 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?
which SPI measurement is more correlated with postoperative pain (time frame: SPI at 5 minutes after skin incision and 10 minutes before recovery). 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 NCT04724564, 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 19 Jan 2022.