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

R

Riga East Clinical University Hospital

Status

Active, not recruiting

Conditions

Postoperative Pain

Treatments

Diagnostic Test: VAS scale for pain control
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,

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Open Laparotomy and gastrectomy

Exclusion criteria

  • acute surgery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

100 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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