Ventral HerniaNCT04438369
Evaluation of Ultrasound-guided Erector Spinae Block for Postoperative Analgesia in Laprascopic Ventral Hernia Repair.
A study testing Erector Spinae Plane Block in people with Ventral Hernia and Postoperative Pain, run by Ostfold Hospital Trust at 1 site in Norway.
Trial summary
Ventral hernia repair is associated with significant postoperative pain, and regional anesthetic techniques are of potential benefit. The postoperative mobility and training is of utmost importance in this patient group, and could be increased using local anesthetics instead of opioids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia, Postoperative Pain, Regional Anesthesia
- What is being tested?
- Erector Spinae Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2020to 15 Dec 2023
- Phase
- Interventional
- 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
The inclusion criteria:
- Age >18
- BMI (body mass index) 18,5 - 40 and weight >65 kg
- ASA (American Association of Anesthesiologists Classification system for physical status) I-III .
- Scheduled for elective ventral hernia operation
- Planned hospital stay >24 hrs
The exclusion criteria;
- Allergy to latex, local anesthesia, Non-Steroidal Anti-Inflammatory Drugs or opioids
- Diabetes
- Chronic pain with daily opiate use
- Patients with severe renal and/or hepatic disease
- Local infection at the site of injection
- Systemic infection
- AV block 2-3
- Inability to understand written or spoken Norwegian
- Inability to cooperate
- Dementia
- Known abuse of alcohol or medication
- Pregnancy
- Weight under 65 kg
Trial locations and contacts
1 site in 1 country.
About this study
Ventral hernia repair is associated with significant postoperative pain, and regional anesthetic techniques are of potential benefit.
The postoperative mobility and training is of utmost importance in this patient group, and could be increased using local anesthetics instead of opioids.
Read more
Inadequate post-operative pain control can lead to adverse consequences for patients, such as the development of chronic pain, immunosuppression, poorer healing of surgical wounds, as well as adrenergic activation and its consequences in the form of coronary incidents or gastrointestinal obstruction and postoperative nausea and vomiting (PONV). Moreover, lack of mobility can result in thrombosis and embolism. These complications affect hospital functioning, which leads to decreased patient satisfaction, a worse reputation for the hospital, longer stays in the recovery room, prolonged hospitalizations, higher incidence of re-surgeries and re-admissions, and higher costs for care and treatment.
Erector spinae plane block (ESPB) is the latest of the truncal blocks and was first described in 2016. The efficacy of bilateral ESPB at the T7 level has been described in a study of 4 cases, moreover effective analgesia with ESPB after bariatric surgery has been described in a study of 3 cases. When performed at the level of the T7 transverse process, studies show the potential to block both supra-umbilical and infra-umbilical dermatomes. So far there are mostly case studies done in this field of study, and internationally there is a call for research into the effect of this technique and randomized controlled trials.
The objective of this study is to compare ESPB to multimodal analgesia in patients undergoing ventral hernia repair.
Read the detailed description
Hypothesis, aims and objectives
The postulated nullhypothesis and alternativ hypothesis is:
H0= there is no difference in opioid consumption postoperatively between multimodal analgesia and ESPB. HA= there is a reduction in opioid consumption postoperatively between standard multimodal analgesia and ESPB.
Sample size calculation
Sample size estimation was calculated from our series of 20 pilot-patients on ventral hernia surgery without block, who needed on average 24.6 mg oral morphine equivalents (OME) iv oxycodone rescue analgesia during the first hour, SD=17.35 mg. Assuming a one sided study and in order to show a 50% reduction in rescue opioid consumption after a successful block with 80% power and 0.05 as level of significance, at least 2 x 26 patients should be studied, total of 52 patients. In order to adjust for missing data and protocol violations we decided to include 2 x 30 patients in our study.
This is a study where all parties are blinded for the allocation. A study nurse draws up the allocated study medication in an unmarked syringe so that the anesthesiologist is blinded. The study nurse responsible for the medication is not the same nurse that does the postoperative scoring. The study nurse responsible for the medication puts masked containers of the allocated medication into opaque envelopes and delivers the envelope to the ward. The ward personnel will then be masked for the allocation. The study nurse responsible for the follow up calls are not the same study nurse responsible for the medications and as such is also blinded for the allocation.
The primary outcome measure is the opiate consumption measured in oral morphine equivalents after 1 hour.
Secondary outcome measures are;
- Opiate consummation after 4 hours, 24 hours, 48 hours and 7 days. As patients receive different types of opiates, opiate consumption will be measured as oral morphine equivalents for ease of comparison. Oksykodon iv is converted by a factor of 1:1,5 to oral morphine.
- Time to first mobilization
- Time to first analgesic requirement
- Pain measuring tool used in this project is the validated numerical rating scale (NRS), which is a 11- point scale from 0-10, where no pain is NRS=0, mild pain is NRS 1-3, moderate pain NRS 4-6 and severe pain 7-10. NRS will be measured at rest and with activity at the time points 1, 2 and 3 hours.
- Sedation is measured by the validated Pasero opioid-induced sedation scale (POSS). The POSS measures normal sleep as S and then the degree of sedation on a numerical scale from 1-4. Will be measured at 1, 2 and 3 hours.
- Nausea and vomiting is measured by the validated PONV impact scale. This is a tool that entails two questions about nausea and vomiting, and each question gets rated on a numeric scale from 0-4. Will be measured at 1, 2 and 3 hours.
After the operation the patients will be asked to answer the QoR-15, which consist of 15 questions distributed on two dimensions: "physical" and "mental" well-being, where the patients report their experiences on a scale from 0 (=not at all) to 10 (=all the time). As a complementing measure to the QoR-15 the patients will also be asked the EQ-5D questionnaire. The EQ-5D questionnaire is an outcome measure of patient health after operation. The EQ-5D-5L is comprised of two different measures; the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). Both QoR-15 and EQ-5D will be measured at 48 hours and 7 days.
The objective is to gain knowledge to support anesthesiologists when deciding analgesic approach, as well as in shared decision-making with patients (including the patient perspective). All results are expected to be presented during the project period.
- Conditions
- Ventral Hernia, Postoperative Pain, Regional Anesthesia
- Being tested
- Erector Spinae Plane Block
- Keywords
- Erector Spinae Plane Block, Postoperative pain, Ventral hernia repair
- Medical subject headings
- Hernia, Ventral, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
Cathether based Erector Spinae Plane Block for postoperative pain management.
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae block | Active comparator | Group ESPB: Multimodal analgesia comprising of preoperative paracetamol adjusted for weight (2000 milligrams (mg) >70 kilograms (kg) <70 years, 1500 mg <70 kg >70 years, 1000 mg <50 kg) and diclofenac adjusted for weight (100 mg >70 kg <70 years, 50 mg <70 kg >70 years). After the operation they receive paracetamol 1000 mg x4 and diclofenac 50 mg x3 a day, as well as PCA with iv oxycodon 1 mg/ml.
Preoperatively positioned bilateral catheters at level T7 injected with ropivacaine 2,5 mg/ml, 30 ml on each side. Postoperative maintenance treatment with injection of 2 mg/ml ropivacaine 30 ml on each side every 6 hours postoperatively. Maximum allowed bolus preoperative ropivacaine dose is 3 mg/kg body weight (BW), while the maximum 24 hour dose postoperatively is 11 mg/kg to avoid local anesthesia systemic toxicity (LAST). The catheter will be discontinued 24 hours after the original procedure. The container with ropivacaine will be masked for blinding of the personnel on the ward. Receives: Procedure: Erector Spinae Plane Block |
| Control | Placebo comparator | Control group with standard multimodal analgesia: Preoperative paracetamol adjusted for weight (2000 milligrams (mg) >70 kilograms (kg) <70 years, 1500 mg <70 kg >70 years, 1000 mg <50 kg) and diclofenac adjusted for weight (100 mg >70 kg <70 years, 50 mg <70 kg >70 years). After the operation they receive paracetamol 1000 mg x4 and diclofenac 50 mg x3 a day, as well as PCA with iv oxycodone 1 mg/ml.
Insertion of bilateral catheters preoperatively. Injection of 30 ml saline preoperatively and every 6 hours postoperatively. The catheter will be discontinued 24 hours after the original procedure. The container with saline will be masked for blinding of the personnel on the ward. Receives: Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opiat consumption
The opioid consumption measured in orale morphine equivalents after one hour postoperatively.
Measured: Postoperatively at one hour.
Secondary outcomes (4)
Postopertive nausea
We will measure postoperative nausea with the Postoperative nausea and vomiting (PONV) impact scale. This is a tool that entails two questions about nausea and vomiting, and each question gets rated on a numeric scale from 0-4.
Measured: Postoperatively at 0-4 hours, 4-24 hours, 24-48 hours and 48 hours-7 days.
Postoperative sedation
We will measure postoperative sedation with the Pasero opioid-induced sedation scale (POSS). The POSS measures normal sleep as S and then the degree of sedation on a numerical scale from 1-4. Will be measured at 1, 2 and 3 hours.
Measured: Postoperatively at 0-4 hours, 4-24 hours, 24-48 hours and 48 hours-7 days.
Postoperative pain
We will measure postoperative pain with postoperative Numeric Rating Scale (NRS). A scale from 0-10 where 0 is no pain and 10 is worst pain imaginable.
Measured: Postoperatively at 1-4 hours, 4-24 hours, 24-48 hours and 48 hours-7 days.
Quality of recovery 15
We will measure the patients quality of recovery with the validated QoR-15 questionaire. This will be done via telephone interviews.
Measured: 24 hours, 48 hours and 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start1 Sep 2020
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventral HerniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is planned as a randomized controlled trial (RCT) with two study arms. One arm is the intervention arm, who will receive the active treatment. The other arm is the control arm, who will receive a placebo treatment.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Soerenstua, MD, Principal investigator, Sykehuset Ostfold HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438369
- Sponsor's protocol ID
- 2018/2239
- Status last verified
- Apr 2023
- First submitted
- 16 Jun 2020
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available upon request.
Publications
Sorenstua M, Raeder J, Vamnes JS, Leonardsen AL. Evaluation of the Erector spinae plane block for postoperative analgesia in laparoscopic ventral hernia repair: a randomized placebo controlled trial. BMC Anesthesiol. 2024 May 29;24(1):192. doi: 10.1186/s12871-024-02566-x.
PubMed 38811911
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ultrasound-guided Erector Spinae Block for Postoperative Analgesia in Laprascopic Ventral Hernia Repair.
- ClinicalTrials.gov ID
- NCT04438369
- Acronym / sponsor ID
- 2018/2239
- Conditions
- Ventral Hernia, Postoperative Pain, Regional Anesthesia
- Keywords
- Erector Spinae Plane Block, Postoperative pain, Ventral hernia repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 18 Jun 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.
Ventral hernia repair is associated with significant postoperative pain, and regional anesthetic techniques are of potential benefit.
The postoperative mobility and training is of utmost importance in this patient group, and could be increased using local anesthetics instead of opioids.
Inadequate post-operative pain control can lead to adverse consequences for patients, such as the development of chronic pain, immunosuppression, poorer healing of surgical wounds, as well as adrenergic activation and its consequences in the form of coronary incidents or gastrointestinal obstruction and postoperative nausea and vomiting (PONV). Moreover, lack of mobility can result in thrombosis and embolism. These complications affect hospital functioning, which leads to decreased patient satisfaction, a worse reputation for the hospital, longer stays in the recovery room, prolonged hospitalizations, higher incidence of re-surgeries and re-admissions, and higher costs for care and treatment.
Erector spinae plane block (ESPB) is the latest of the truncal blocks and was first described in 2016. The efficacy of bilateral ESPB at the T7 level has been described in a study of 4 cases, moreover effective analgesia with ESPB after bariatric surgery has been described in a study of 3 cases. When performed at the level of the T7 transverse process, studies show the potential to block both supra-umbilical and infra-umbilical dermatomes. So far there are mostly case studies done in this field of study, and internationally there is a call for research into the effect of this technique and randomized controlled trials.
The objective of this study is to compare ESPB to multimodal analgesia in patients undergoing ventral hernia repair.
Detailed description
Hypothesis, aims and objectives
The postulated nullhypothesis and alternativ hypothesis is:
H0= there is no difference in opioid consumption postoperatively between multimodal analgesia and ESPB. HA= there is a reduction in opioid consumption postoperatively between standard multimodal analgesia and ESPB.
Sample size calculation
Sample size estimation was calculated from our series of 20 pilot-patients on ventral hernia surgery without block, who needed on average 24.6 mg oral morphine equivalents (OME) iv oxycodone rescue analgesia during the first hour, SD=17.35 mg. Assuming a one sided study and in order to show a 50% reduction in rescue opioid consumption after a successful block with 80% power and 0.05 as level of significance, at least 2 x 26 patients should be studied, total of 52 patients. In order to adjust for missing data and protocol violations we decided to include 2 x 30 patients in our study.
This is a study where all parties are blinded for the allocation. A study nurse draws up the allocated study medication in an unmarked syringe so that the anesthesiologist is blinded. The study nurse responsible for the medication is not the same nurse that does the postoperative scoring. The study nurse responsible for the medication puts masked containers of the allocated medication into opaque envelopes and delivers the envelope to the ward. The ward personnel will then be masked for the allocation. The study nurse responsible for the follow up calls are not the same study nurse responsible for the medications and as such is also blinded for the allocation.
The primary outcome measure is the opiate consumption measured in oral morphine equivalents after 1 hour.
Secondary outcome measures are;
- Opiate consummation after 4 hours, 24 hours, 48 hours and 7 days. As patients receive different types of opiates, opiate consumption will be measured as oral morphine equivalents for ease of comparison. Oksykodon iv is converted by a factor of 1:1,5 to oral morphine.
- Time to first mobilization
- Time to first analgesic requirement
- Pain measuring tool used in this project is the validated numerical rating scale (NRS), which is a 11- point scale from 0-10, where no pain is NRS=0, mild pain is NRS 1-3, moderate pain NRS 4-6 and severe pain 7-10. NRS will be measured at rest and with activity at the time points 1, 2 and 3 hours.
- Sedation is measured by the validated Pasero opioid-induced sedation scale (POSS). The POSS measures normal sleep as S and then the degree of sedation on a numerical scale from 1-4. Will be measured at 1, 2 and 3 hours.
- Nausea and vomiting is measured by the validated PONV impact scale. This is a tool that entails two questions about nausea and vomiting, and each question gets rated on a numeric scale from 0-4. Will be measured at 1, 2 and 3 hours.
After the operation the patients will be asked to answer the QoR-15, which consist of 15 questions distributed on two dimensions: "physical" and "mental" well-being, where the patients report their experiences on a scale from 0 (=not at all) to 10 (=all the time). As a complementing measure to the QoR-15 the patients will also be asked the EQ-5D questionnaire. The EQ-5D questionnaire is an outcome measure of patient health after operation. The EQ-5D-5L is comprised of two different measures; the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). Both QoR-15 and EQ-5D will be measured at 48 hours and 7 days.
The objective is to gain knowledge to support anesthesiologists when deciding analgesic approach, as well as in shared decision-making with patients (including the patient perspective). All results are expected to be presented during the project period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is planned as a randomized controlled trial (RCT) with two study arms. One arm is the intervention arm, who will receive the active treatment. The other arm is the control arm, who will receive a placebo treatment.
| Arm | Type | Receives |
|---|---|---|
| Erector spinae block | Active comparator | Procedure: Erector Spinae Plane BlockGroup ESPB: Multimodal analgesia comprising of preoperative paracetamol adjusted for weight (2000 milligrams (mg) >70 kilograms (kg) <70 years, 1500 mg <70 kg >70 years, 1000 mg <50 kg) and diclofenac adjusted for weight (100 mg >70 kg <70 years, 50 mg <70 kg >70 years). After the operation they receive paracetamol 1000 mg x4 and diclofenac 50 mg x3 a day, as well as PCA with iv oxycodon 1 mg/ml. Preoperatively positioned bilateral catheters at level T7 injected with ropivacaine 2,5 mg/ml, 30 ml on each side. Postoperative maintenance treatment with injection of 2 mg/ml ropivacaine 30 ml on each side every 6 hours postoperatively. Maximum allowed bolus preoperative ropivacaine dose is 3 mg/kg body weight (BW), while the maximum 24 hour dose postoperatively is 11 mg/kg to avoid local anesthesia systemic toxicity (LAST). The catheter will be discontinued 24 hours after the original procedure. The container with ropivacaine will be masked for blinding of the personnel on the ward. |
| Control | Placebo comparator | Procedure: Erector Spinae Plane BlockControl group with standard multimodal analgesia: Preoperative paracetamol adjusted for weight (2000 milligrams (mg) >70 kilograms (kg) <70 years, 1500 mg <70 kg >70 years, 1000 mg <50 kg) and diclofenac adjusted for weight (100 mg >70 kg <70 years, 50 mg <70 kg >70 years). After the operation they receive paracetamol 1000 mg x4 and diclofenac 50 mg x3 a day, as well as PCA with iv oxycodone 1 mg/ml. Insertion of bilateral catheters preoperatively. Injection of 30 ml saline preoperatively and every 6 hours postoperatively. The catheter will be discontinued 24 hours after the original procedure. The container with saline will be masked for blinding of the personnel on the ward. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Erector Spinae Plane BlockCathether based Erector Spinae Plane Block for postoperative pain management. | Procedure or surgery | Control, Erector spinae block |
Primary outcome
Opiat consumption
Time frame: Postoperatively at one hour.
The opioid consumption measured in orale morphine equivalents after one hour postoperatively.
4 secondary outcomes
Postopertive nausea
Time frame: Postoperatively at 0-4 hours, 4-24 hours, 24-48 hours and 48 hours-7 days.
Postoperative sedation
Time frame: Postoperatively at 0-4 hours, 4-24 hours, 24-48 hours and 48 hours-7 days.
Postoperative pain
Time frame: Postoperatively at 1-4 hours, 4-24 hours, 24-48 hours and 48 hours-7 days.
Quality of recovery 15
Time frame: 24 hours, 48 hours and 7 days.
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 31 Jan 2024.
- Derived from this study: PubMed 38811911Sorenstua M, Raeder J, Vamnes JS, Leonardsen AL. Evaluation of the Erector spinae plane block for postoperative analgesia in laparoscopic ventral hernia repair: a randomized placebo controlled trial. BMC Anesthesiol. 2024 May 29;24(1):192. doi: 10.1186/s12871-024-02566-x.
- Individual participant dataSharing planned: Yes. IPD will be available upon request.
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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.
Marie Soerenstua, MD principal investigator
Sykehuset Ostfold HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block in people with Ventral Hernia and Postoperative Pain, run by Ostfold Hospital Trust at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 31 Jan 2024. 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 Norway. 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. Some participants in this study may receive a placebo. 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?
Opiat consumption (time frame: Postoperatively at one hour.). 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 NCT04438369, which also lists 1 linked publication.
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 31 Jan 2024.