Postoperative PainNCT05592496
Bilateral Retromuscular Rectus Sheath Block Catheters Usage for Early Postoperative Analgesia After Laparotomic Gastrectomy.
A study testing Bilateral retromuscular rectus sheath block catheters usage for early postoperative analgesia after laparotomic gastrectomy., Catheter insertion technique by using special tube t and Connection of catheters bilateraly to "easy pump" system, in people with Postoperative Pain, run by Riga East Clinical University Hospital at 2 sites in Latvia.
Trial summary
In early postoperative period, the occurrence of severe pain after open major upper GI surgery is a significant issue. The study is aimed to access the efficiency of rectus sheet block with continuous bupivacaine infusion catheters into retromuscular space in providing an effective pain relief, decreasing opioid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bilateral retromuscular rectus sheath block catheters usage for early postoperative analgesia after laparotomic gastrectomy., Catheter insertion technique by using special tube t and Connection of catheters bilateraly to "easy pump" system,
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesLatvia
- Study dates
- 1 Jan 2021to 31 Jan 2024
- 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
Who may be able to join
- Open Laparotomy and gastrectomy
Who cannot join
- acute surgery
Trial locations and contacts
2 sites in 1 country.
Latvia2 sites
Igors Ivanovs
Riga, LV1038
Riga East Clinical University hospital
Riga, LV1038
About this study
In early postoperative period, the occurrence of severe pain after open major upper GI surgery is a significant issue. The study is aimed to access the efficiency of rectus sheet block with continuous bupivacaine infusion catheters into retromuscular space in providing an effective pain relief, decreasing opioid consumption and enhancing postoperative recovery.
Read the detailed description
This prospective randomised case-control experimental study is being conducted in Riga East University Hospital (Latvia). Patients with total or subtotal open gastrectomy were divided into two groups - half patients in the Block group and half patients in the Control group. In the Block group and control group, retromuscular catheters in the m. rectus abdominis sheath is going to be placed before fascia closure. Catheters will be placed under the direct supervision of a surgeon throughout the operation wound on both sides of the incision.
After surgery patients in the Block group will receive continuous 0.125% (10-12 mg/h) bupivacaine infusion through rectus sheath catheters for 72 h. Additionaly ketorolac or trimeperidine infusion will be performed if VAS of pains more than 30mm. If pains continue, additional opioids will be performed.
Patients in the Control group received 0,9% NaCl solution 72 hours by using the same "easy pump" system, and ketorolac or trimeperidine injection if necessery Pain intensity will be assessed in both groups using 0-100 mm Visual Analog Scale (VAS) at 24, 48 and 72 hour intervals after surgery at rest and during movement (by asking the patient to bend legs). Postoperative complications, hospital stay, comorbidities, the time taken to start walking after the surgery, bowel movements (time until first stool) were all examined.
- Conditions
- Postoperative Pain
- Being tested
- Bilateral retromuscular rectus sheath block catheters usage for early postoperative analgesia after laparotomic gastrectomy., Catheter insertion technique by using special tube t, Connection of catheters bilateraly to "easy pump" system,, VAS scale for pain control
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral retromuscular rectus sheath block catheters usage for early postoperative analgesia after laparotomic gastrectomy.Procedure or surgery
Also called Catheter insertion technique by using special tube to positionate it in retromuscular space
After surgery patients in the Block group receives continuous 0.125% (10-12 mg/h) bupivacaine infusion through rectus sheath catheters for 72 h in addition to fentanyl i/v infusion on postoperative day 0, and ketorolac or trimeperidine injection on postoperative day 1-2 if necessery. Patients in the Control group receives NaCl 0,9% infusion and fentanyl i/v infusion on postoperative day 0 and ketorolac or trimeperidine injection on postoperative day 1-2 if necessery Pain intensity is going to be assessed in both groups using 0-100 mm Visual Analog Scale (VAS) at 24, 48 and 72 hour intervals after surgery at rest and during movement (by asking the patient to bend legs). Postoperative complications, hospital stay, comorbidities, the time taken to start walking after the surgery, bowel movements (time until first stool) were all examined.
Catheter insertion technique by using special tube tDevice
By using special tube, it is possible to locate the catheters in retromuscular space, where they are close to cutaneous nervs
Connection of catheters bilateraly to "easy pump" system,Procedure or surgery
Connection of catheters, which are inserted in to retromuscular space, to ensure continuous receiving of Bupivacaine fluid for analgesia. "Easy pump" system provides continous receiving of bupivacaine fluid infusion speed - 5ml per hour
VAS scale for pain controlDiagnostic test
By using Visual Analog scale of pains, the pain score is fixed
| Study group | Role | What they receive |
|---|---|---|
| Block group | Active comparator | Patients after laparotomic gastrectomy and musculus rectus sheath block and continuous analgesia with 0,125% bupivacaine solution for 72h Receives: Procedure: Bilateral retromuscular rectus sheath block catheters usage for early postoperative analgesia after laparotomic gastrectomy.; Device: Catheter insertion technique by using special tube t; Procedure: Connection of catheters bilateraly to "easy pump" system,; Diagnostic Test: VAS scale for pain control |
| Control group | Placebo comparator | Patients after laparotomic gastrectomy, musculus rectus sheath block and induction of 0,9% NaCl Solution by using "easy pump" system for 72 h Receives: Procedure: Bilateral retromuscular rectus sheath block catheters usage for early postoperative analgesia after laparotomic gastrectomy.; Device: Catheter insertion technique by using special tube t; Procedure: Connection of catheters bilateraly to "easy pump" system,; Diagnostic Test: VAS scale for pain control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Patients will be asked to score their pain in recovery and on days 0,1,2,3 post surgery
Measured: 3 days
Opioid usage after surgery
If the VAS of pains is more than 30mm, after receiving NSAIDs, opioid solution will be performed
Measured: 3 days
Secondary outcomes (4)
Peri-operative analgesic use
Analgesic use intra-operatively and post-operatively for 3 days. This will include strong opioids, paracetamol, NSAIDs, codeine, ketamine, IV lignocaine, tramadol, clonidine and PCA usage post-operatively.
Measured: 4 days
TIme to diet and mobilisation
Time to first defecation
Measured: likely 5 days
Time to discharge
how many days after Surgery
Measured: approximately 7 days
Postoperative complications
all postoperative complications (Clavien Dindo classification)
Measured: approximately 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start1 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riga East Clinical University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Latvia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592496
- Sponsor's protocol ID
- 001
- Status last verified
- Oct 2022
- First submitted
- 6 Oct 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Retromuscular Rectus Sheath Block Catheters Usage for Early Postoperative Analgesia After Laparotomic Gastrectomy.
- ClinicalTrials.gov ID
- NCT05592496
- Acronym / sponsor ID
- 001
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Riga East Clinical University HospitalOther government
- Collaborators
- University of Latvia
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 24 Oct 2022 (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.
In early postoperative period, the occurrence of severe pain after open major upper GI surgery is a significant issue. The study is aimed to access the efficiency of rectus sheet block with continuous bupivacaine infusion catheters into retromuscular space in providing an effective pain relief, decreasing opioid consumption and enhancing postoperative recovery.
Detailed description
This prospective randomised case-control experimental study is being conducted in Riga East University Hospital (Latvia). Patients with total or subtotal open gastrectomy were divided into two groups - half patients in the Block group and half patients in the Control group. In the Block group and control group, retromuscular catheters in the m. rectus abdominis sheath is going to be placed before fascia closure. Catheters will be placed under the direct supervision of a surgeon throughout the operation wound on both sides of the incision.
After surgery patients in the Block group will receive continuous 0.125% (10-12 mg/h) bupivacaine infusion through rectus sheath catheters for 72 h. Additionaly ketorolac or trimeperidine infusion will be performed if VAS of pains more than 30mm. If pains continue, additional opioids will be performed.
Patients in the Control group received 0,9% NaCl solution 72 hours by using the same "easy pump" system, and ketorolac or trimeperidine injection if necessery Pain intensity will be assessed in both groups using 0-100 mm Visual Analog Scale (VAS) at 24, 48 and 72 hour intervals after surgery at rest and during movement (by asking the patient to bend legs). Postoperative complications, hospital stay, comorbidities, the time taken to start walking after the surgery, bowel movements (time until first stool) were all examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Block group | Active comparator | Procedure: Bilateral retromuscular rectus sheath block catheters usage for early postoperative analgesia after laparotomic gastrectomy., Device: Catheter insertion technique by using special tube t, Procedure: Connection of catheters bilateraly to "easy pump" system,, Diagnostic Test: VAS scale for pain controlPatients after laparotomic gastrectomy and musculus rectus sheath block and continuous analgesia with 0,125% bupivacaine solution for 72h |
| Control group | Placebo comparator | Procedure: Bilateral retromuscular rectus sheath block catheters usage for early postoperative analgesia after laparotomic gastrectomy., Device: Catheter insertion technique by using special tube t, Procedure: Connection of catheters bilateraly to "easy pump" system,, Diagnostic Test: VAS scale for pain controlPatients after laparotomic gastrectomy, musculus rectus sheath block and induction of 0,9% NaCl Solution by using "easy pump" system for 72 h |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Open Laparotomy and gastrectomy
Key exclusion criteria (1 listed)
- acute surgery
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 |
|---|---|---|
| Bilateral retromuscular rectus sheath block catheters usage for early postoperative analgesia after laparotomic gastrectomy.Also: Catheter insertion technique by using special tube to positionate it in retromuscular spaceAfter surgery patients in the Block group receives continuous 0.125% (10-12 mg/h) bupivacaine infusion through rectus sheath catheters for 72 h in addition to fentanyl i/v infusion on postoperative day 0, and ketorolac or trimeperidine injection on postoperative day 1-2 if necessery. Patients in the Control group receives NaCl 0,9% infusion and fentanyl i/v infusion on postoperative day 0 and ketorolac or trimeperidine injection on postoperative day 1-2 if necessery Pain intensity is going to be assessed in both groups using 0-100 mm Visual Analog Scale (VAS) at 24, 48 and 72 hour intervals after surgery at rest and during movement (by asking the patient to bend legs). Postoperative complications, hospital stay, comorbidities, the time taken to start walking after the surgery, bowel movements (time until first stool) were all examined. | Procedure or surgery | Block group, Control group |
| Catheter insertion technique by using special tube tBy using special tube, it is possible to locate the catheters in retromuscular space, where they are close to cutaneous nervs | Device | Block group, Control group |
| Connection of catheters bilateraly to "easy pump" system,Connection of catheters, which are inserted in to retromuscular space, to ensure continuous receiving of Bupivacaine fluid for analgesia. "Easy pump" system provides continous receiving of bupivacaine fluid infusion speed - 5ml per hour | Procedure or surgery | Block group, Control group |
| VAS scale for pain controlBy using Visual Analog scale of pains, the pain score is fixed | Diagnostic test | Block group, Control group |
Primary outcome
Pain scores
Time frame: 3 days
Patients will be asked to score their pain in recovery and on days 0,1,2,3 post surgery
Opioid usage after surgery
Time frame: 3 days
If the VAS of pains is more than 30mm, after receiving NSAIDs, opioid solution will be performed
4 secondary outcomes
Peri-operative analgesic use
Time frame: 4 days
TIme to diet and mobilisation
Time frame: likely 5 days
Time to discharge
Time frame: approximately 7 days
Postoperative complications
Time frame: approximately 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral retromuscular rectus sheath block catheters usage for early postoperative analgesia after laparotomic gastrectomy., Catheter insertion technique by using special tube t and Connection of catheters bilateraly to "easy pump" system, in people with Postoperative Pain, run by Riga East Clinical University Hospital at 2 sites in Latvia.
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 1 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: status not confirmed, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Latvia. 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?
Results are not available in the source record.
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?
Pain scores (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2022.