Bilateral Retromuscular Rectus Sheath Block Catheters Usage for Early Postoperative Analgesia After Laparotomic Gastrectomy.

Not Applicable

Active, not recruiting

• Conditions: Postoperative Pain
• Interventions: 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

• Registration Number: NCT05592496
• Lead Sponsor: Riga East Clinical University Hospital

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.

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-10-20
• Last Update Submitted: 2022-10-20
• Study First Posted: 2022-10-24
• Last Update Posted: 2022-10-24
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Open Laparotomy and gastrectomy

Exclusion Criteria

• acute surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Block group	Catheter insertion technique by using special tube t	Patients after laparotomic gastrectomy and musculus rectus sheath block and continuous analgesia with 0,125% bupivacaine solution for 72h
Block group	Connection of catheters bilateraly to "easy pump" system,	Patients after laparotomic gastrectomy and musculus rectus sheath block and continuous analgesia with 0,125% bupivacaine solution for 72h
Block group	VAS scale for pain control	Patients after laparotomic gastrectomy and musculus rectus sheath block and continuous analgesia with 0,125% bupivacaine solution for 72h
Block group	Bilateral retromuscular rectus sheath block catheters usage for early postoperative analgesia after laparotomic gastrectomy.	Patients after laparotomic gastrectomy and musculus rectus sheath block and continuous analgesia with 0,125% bupivacaine solution for 72h
Control group	Bilateral retromuscular rectus sheath block catheters usage for early postoperative analgesia after laparotomic gastrectomy.	Patients after laparotomic gastrectomy, musculus rectus sheath block and induction of 0,9% NaCl Solution by using "easy pump" system for 72 h
Control group	Catheter insertion technique by using special tube t	Patients after laparotomic gastrectomy, musculus rectus sheath block and induction of 0,9% NaCl Solution by using "easy pump" system for 72 h
Control group	VAS scale for pain control	Patients after laparotomic gastrectomy, musculus rectus sheath block and induction of 0,9% NaCl Solution by using "easy pump" system for 72 h
Control group	Connection of catheters bilateraly to "easy pump" system,	Patients after laparotomic gastrectomy, musculus rectus sheath block and induction of 0,9% NaCl Solution by using "easy pump" system for 72 h

Primary Outcome Measures

Name	Time	Method
Pain scores	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	3 days	If the VAS of pains is more than 30mm, after receiving NSAIDs, opioid solution will be performed

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	approximately 14 days	all postoperative complications (Clavien Dindo classification)
Peri-operative analgesic use	4 days	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	likely 5 days	Time to first defecation
Time to discharge	approximately 7 days	how many days after Surgery

Trial Locations

Locations (2)

Igors Ivanovs; 🇱🇻 Riga, Latvia

Riga East Clinical University hospital; 🇱🇻 Riga, Latvia