Bilateral Retromuscular Rectus Sheath Block Catheters Usage for Early Postoperative Analgesia After Laparotomic Gastrectomy.
Primary Purpose
Postoperative Pain
Status
Active
Phase
Not Applicable
Locations
Latvia
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- Open Laparotomy and gastrectomy
Exclusion Criteria:
- acute surgery
Sites / Locations
- Igors Ivanovs
- Riga East Clinical University hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Block group
Control group
Arm Description
Patients after laparotomic gastrectomy and musculus rectus sheath block and continuous analgesia with 0,125% bupivacaine solution for 72h
Patients after laparotomic gastrectomy, musculus rectus sheath block and induction of 0,9% NaCl Solution by using "easy pump" system for 72 h
Outcomes
Primary Outcome Measures
Pain scores
Patients will be asked to score their pain in recovery and on days 0,1,2,3 post surgery
Opioid usage after surgery
If the VAS of pains is more than 30mm, after receiving NSAIDs, opioid solution will be performed
Secondary Outcome Measures
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.
TIme to diet and mobilisation
Time to first defecation
Time to discharge
how many days after Surgery
Postoperative complications
all postoperative complications (Clavien Dindo classification)
Full Information
NCT ID
NCT05592496
First Posted
October 6, 2022
Last Updated
October 20, 2022
Sponsor
Riga East Clinical University Hospital
Collaborators
University of Latvia
1. Study Identification
Unique Protocol Identification Number
NCT05592496
Brief Title
Bilateral Retromuscular Rectus Sheath Block Catheters Usage for Early Postoperative Analgesia After Laparotomic Gastrectomy.
Official Title
Bilateral Retromuscular Rectus Sheath Block Catheters Usage for Early Postoperative Analgesia After Laparotomic Gastrectomy.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riga East Clinical University Hospital
Collaborators
University of Latvia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Block group
Arm Type
Active Comparator
Arm Description
Patients after laparotomic gastrectomy and musculus rectus sheath block and continuous analgesia with 0,125% bupivacaine solution for 72h
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients after laparotomic gastrectomy, musculus rectus sheath block and induction of 0,9% NaCl Solution by using "easy pump" system for 72 h
Intervention Type
Procedure
Intervention Name(s)
Bilateral retromuscular rectus sheath block catheters usage for early postoperative analgesia after laparotomic gastrectomy.
Other Intervention Name(s)
Catheter insertion technique by using special tube to positionate it in retromuscular space
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Catheter insertion technique by using special tube t
Intervention Description
By using special tube, it is possible to locate the catheters in retromuscular space, where they are close to cutaneous nervs
Intervention Type
Procedure
Intervention Name(s)
Connection of catheters bilateraly to "easy pump" system,
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
VAS scale for pain control
Intervention Description
By using Visual Analog scale of pains, the pain score is fixed
Primary Outcome Measure Information:
Title
Pain scores
Description
Patients will be asked to score their pain in recovery and on days 0,1,2,3 post surgery
Time Frame
3 days
Title
Opioid usage after surgery
Description
If the VAS of pains is more than 30mm, after receiving NSAIDs, opioid solution will be performed
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Peri-operative analgesic use
Description
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.
Time Frame
4 days
Title
TIme to diet and mobilisation
Description
Time to first defecation
Time Frame
likely 5 days
Title
Time to discharge
Description
how many days after Surgery
Time Frame
approximately 7 days
Title
Postoperative complications
Description
all postoperative complications (Clavien Dindo classification)
Time Frame
approximately 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Open Laparotomy and gastrectomy
Exclusion Criteria:
acute surgery
Facility Information:
Facility Name
Igors Ivanovs
City
Riga
ZIP/Postal Code
LV1038
Country
Latvia
Facility Name
Riga East Clinical University hospital
City
Riga
ZIP/Postal Code
LV1038
Country
Latvia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Bilateral Retromuscular Rectus Sheath Block Catheters Usage for Early Postoperative Analgesia After Laparotomic Gastrectomy.
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