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Trial registered on ANZCTR

Registration number

ACTRN12624001083583

Ethics application status

Approved

Date submitted

25/07/2024

Date registered

6/09/2024

Date last updated

6/09/2024

Date data sharing statement initially provided

6/09/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

Is the Rectus Sheath block effective as the sole anesthetic technique for inserting a peritoneal catheter in patients with renal failure?

Scientific title

Peritoneal catheter: The effectiveness of Rectus Abdominis Sheath block as the sole anesthetic technique in patients who will undergo open surgery for the placement of a peritoneal catheter

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

chronic kidney disease

end-stage renal disease

Condition category

Condition code

Anaesthesiology

Anaesthetics

Anaesthesiology

Pain management

Surgery

Surgical techniques

Renal and Urogenital

Kidney disease

Renal and Urogenital

Other renal and urogenital disorders

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

This is a prospective study. The study will include thirty consecutive patients or the available number of patients meeting the inclusion criteria within a period of 2 years. The subjects are patients with end-stage renal disease, according to The American Society of Anesthesiologists Physical Status Classification System (ASA) classified as II, III, or IV, who will undergo open surgery for the placement of a peritoneal catheter. The Bilateral Rectus Abdominis Sheath (RAS) block will be used as the sole anesthetic technique, administered under ultrasound guidance in a standardized manner. In our hospital, the Bilateral Rectus Abdominis Sheath (RAS) block technique is routinely employed for all patients undergoing peritoneal catheter insertion. Therefore, its use will not be exclusive to participants in this study. It will be performed by an experienced anesthesiologist (defined as having more than 10 years of clinical practice experience). To perform the RAS block, the patient is in the supine position and the ultrasound probe is positioned in a transverse orientation above the umbilicus, approximately 1 cm from the midline. The needle is inserted in-plane in a mediolateral direction through the subcutaneous tissue to penetrate the anterior sheath of the rectus abdominis muscle. The needle is then advanced through the muscle until its tip reaches the posterior sheath. After negative aspiration, the correct needle placement for the RAS block is confirmed by hydrodistension of the space between the flat abdominal muscle and the posterior sheath of the rectus under direct ultrasound guidance. The procedure will be performed bilaterally. For the RAS block, 2.0 mg/kg of 0.5% levobupivacaine will be used. 15 mL on each side, totaling 30 ml. .Before the surgery, the effectiveness of the block will be assessed with a cold sensation test and a pinprick pain test at the incision site. Immediately prior to the skin incision, patients will be sedated with remimidazolam to achieve a targeted Richmond Agitation Sedation Scale (RASS) score of -2 to -3, ensuring appropriate sedation for the regional anesthesia. Sufentanil (total of 10 mcg) will be administered to address anticipated discomfort from touching deep structures not covered by the block. Pain levels will be monitored using The Numeric Pain Rating Scale (NPRS) during the procedure, and if the NPRS score is 4 or higher, the patient will be converted to general anesthesia. A successful block will be indicated by not needing to switch to general anesthesia and no requirement for additional local anesthesia by the surgeon. Duration of the surgery is up to 1 hour. The recorded demographic data will include: age, sex, height, and weight. The recorded clinical data will include: ASA status, amount and dose of local anesthetic (LA), additional LA administered by the surgeon, conversion to general anesthesia, and NPRS scale immediately after the incision during the placement of the peritoneal catheter, and after the surgery at 1 and 6 hours after surgery, both at rest and during movement. Additionally, heart rate (HR), systolic blood pressure (SBP), and diastolic blood pressure (DBP) will be recorded every 5 minutes, along with the need and dose of additional opioid analgesia, sedation level according to the RASS, and the need and dose of postoperative analgesia based on the NPRS. Also, every strategy used to assess adherence to the intervention will be recorded by the anesthesiologist. Complications arising from the block will also be recorded, including vascular puncture, damage to abdominal structures, hypotension, intravascular injection of LA or signs of local anesthetic systemic toxicity (LAST), and the percentage of failed blocks that required conversion to other types of anesthesia. Also, surgical complications will be recorded. At least once every month in a period of one year after the placement of the catheter, catheter function will be recorded, and complications like: catheter infection, primary and secondary peritonitis and mechanical complications (bleeding, "leak," catheter migration) will be noted.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Success of the RAS block

Timepoint [1]

NPRS scale immediately after the incision and during the placement of the peritoneal catheter.

Primary outcome [2]

Surgical complications

Timepoint [2]

Every month for the period of one year after the placement of the catheter or earlier in a case of emergency.

Secondary outcome [1]

Duration of block

Timepoint [1]

NPRS scale after the surgery at 1 and 6 hours, both at rest and during movement.

Secondary outcome [2]

Hemodynamics

Timepoint [2]

HR will be measured by standard ECG monitor every 5 minutes during the operation

Secondary outcome [3]

Sedation

Timepoint [3]

Every 5 minutes during the procedure

Secondary outcome [4]

Pain management: Need and dose of additional opioid analgesia during surgery and need and dose of postoperative analgesia based on the NPRS.

Timepoint [4]

NPRS scale during the surgery and after at 1 and 6 hours, both at rest and during movement.

Secondary outcome [5]

Side-effects

Timepoint [5]

The potential side effects mentioned will be noted immediately after performing the block and 1 and 6 hours after the surgery and recorded in patients medical records

Secondary outcome [6]

Hemodynamics

Timepoint [6]

SBP will be measured using an automated digital blood pressure monitor at 5-minute intervals throughout the duration of the surgery.

Secondary outcome [7]

Hemodynamics

Timepoint [7]

DBP will be measured using an automated digital blood pressure monitor at 5-minute intervals throughout the duration of the surgery.

Eligibility

Key inclusion criteria

The participants are patients who will undergo open surgery for the placement of a peritoneal catheter because of end-stage renal disease. ASA grade 2, 3 and 4. Age 18 years and over.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients refusal, age under 18 years, infection at the injection site, severe coagulopathy, and allergy to local anesthetic.

Study design

Purpose

Duration

Longitudinal

Selection

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

30/09/2024

Actual

Date of last participant enrolment

Anticipated

1/10/2026

Actual

Date of last data collection

Anticipated

1/10/2027

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Croatia

State/province [1]

Zagreb

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

University Hospital Center Sestre milosrdnice

Address [1]

Country [1]

Croatia

Primary sponsor type

Hospital

Name

University Hospital Center Sestre milosrdnice

Address

Country

Croatia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

ETICKO POVJERENSTVO KILINICKOG BOLNICKOG CENTRA SESTRE MILOSRDNICE

Ethics committee address [1]

UHC Sestre milosrdnice, Vinogradska c. 29, 10000 Zagreb, Croatia

Ethics committee country [1]

Croatia

Date submitted for ethics approval [1]

01/07/2024

Approval date [1]

09/07/2024

Ethics approval number [1]

Summary

Brief summary

The primary objective of our study is to determine whether the Rectus Abdominis Sheath (RAS) block can be used as a standalone anesthetic method for the placement of a peritoneal catheter using an open surgical technique. Open surgical technique is safe with minimal surgical or infectious complications. Research Hypothesis is that RAS block can be used as a standalone anesthetic method for the placement of a peritoneal catheter. Also, open surgical technique is safe method of choice for peritoneal catheter placement.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Tomislav Radocaj

Address

UHC Sestre milosrdnice, Vinogradska c. 29, 10000 Zagreb

Country

Croatia

Phone

+385911262586

Fax

[email protected]

Contact person for public queries

Name

Tomislav Radocaj

Address

UHC Sestre milosrdnice, Vinogradska c. 29, 10000 Zagreb

Country

Croatia

Phone

+385911262586

Fax

[email protected]

Contact person for scientific queries

Name

Tomislav Radocaj

Address

UHC Sestre milosrdnice, Vinogradska c. 29, 10000 Zagreb

Country

Croatia

Phone

+385911262586

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
24040	Ethical approval					388173-(Uploaded-23-07-2024-03-57-44)-Image_001.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically