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

NCT05592496 | Unknown

• 1 other identifier: 001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• Pain scores

  Patients will be asked to score their pain in recovery and on days 0,1,2,3 post surgery

  3 days

• Opioid usage after surgery

  If the VAS of pains is more than 30mm, after receiving NSAIDs, opioid solution will be performed

  3 days

Secondary Outcomes (4)

• Peri-operative analgesic use

  4 days

• TIme to diet and mobilisation

  likely 5 days

• Time to discharge

  approximately 7 days

• Postoperative complications

  approximately 14 days

Study Arms (2)

Block group

ACTIVE COMPARATOR

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

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

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

Interventions

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

Also known as: Catheter insertion technique by using special tube to positionate it in retromuscular space

Block group; Control group

Catheter insertion technique by using special tube t DEVICE

By using special tube, it is possible to locate the catheters in retromuscular space, where they are close to cutaneous nervs

Block group; Control group

Connection of catheters bilateraly to "easy pump" system, 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

Block group; Control group

VAS scale for pain control DIAGNOSTIC_TEST

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

Block group; Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Open Laparotomy and gastrectomy

You may not qualify if:

• acute surgery

Sponsors & Collaborators

• Riga East Clinical University Hospital: lead
• University of Latvia: collaborator

Study Sites (2)

Igors Ivanovs

Riga, LV1038, Latvia

Location

Riga East Clinical University hospital

Riga, LV1038, Latvia

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 24, 2022
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: October 24, 2022

Record last verified: 2022-10

Locations

LA (2)