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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2024-01-31

Brief Summary

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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.

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Detailed Description

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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

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Block group

Patients after laparotomic gastrectomy and musculus rectus sheath block and continuous analgesia with 0,125% bupivacaine solution for 72h

Group Type ACTIVE_COMPARATOR

Bilateral retromuscular rectus sheath block catheters usage for early postoperative analgesia after laparotomic gastrectomy.

Intervention Type PROCEDURE

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 t

Intervention Type DEVICE

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,

Intervention Type PROCEDURE

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 control

Intervention Type DIAGNOSTIC_TEST

By using Visual Analog scale of pains, the pain score is fixed

Control group

Patients after laparotomic gastrectomy, musculus rectus sheath block and induction of 0,9% NaCl Solution by using "easy pump" system for 72 h

Group Type PLACEBO_COMPARATOR

Bilateral retromuscular rectus sheath block catheters usage for early postoperative analgesia after laparotomic gastrectomy.

Intervention Type PROCEDURE

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 t

Intervention Type DEVICE

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,

Intervention Type PROCEDURE

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 control

Intervention Type DIAGNOSTIC_TEST

By using Visual Analog scale of pains, the pain score is fixed

Interventions

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