Rectus Sheath Block May Relieve Urethral Catheter Pain

Prostatectomy Clinical Trial

Official title:

THE EFFECT OF ULTRASOUND GUIDED RECTUS SHEATH BLOCK ON POSTOPERATIVE ANALGESIA AND URETHRAL CATHETER PAIN IN ROBOTIC PROSTATECTOMY OPERATIONS: A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05242198
• Other study ID #: Cosarcan2
• Status: Completed
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: September 21, 2022

Study information

• Verified date: December 2022
• Source: V.K.V. American Hospital, Istanbul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to investigate the analgesic efficacy of rectus sheath block and its effect on urethral catheter discomfort in robotic prostatectomy operations.

Description:

Our study will be performed on patients who will undergo elective robotic prostatectomy at the American Hospital and Koc University Hospital.All patients will be sedated with midazolam (0.02 mg/kg), following appropriate ASA monitoring and administration of oxygen by mask. All patients will be operated on under general anesthesia. Propofol (Propofol-Lipuro 10mg/ml, Braun) (2 mg/kg), fentanyl (Talinat 0.5mg, Vem İlaç) (0.8µg/kg) and rocuronium (Esmeron 10mg/ml) for the induction of general anesthesia following appropriate monitoring. Following the administration of MSD) (0.6 mg/kg), endotracheal intubation will be performed. For the maintenance of anesthesia, desflurane (Suprane, Baxter) (1 MAC) and remifentanil (Rentanil 2mg, Vem İlaç) (0.05 - 0.2 µg/kg/min) will be administered. Invasive monitoring will be performed on all patients through the radial artery cannula. Depth of anesthesia will be monitored with BIS (Bispectral Index Monitor), and BIS values will be adjusted to be 40-60. In all patients, dexamethasone (Onadron 8mg/2ml, İbrahim Etem) (4mg), ibuprofen 800mg (Intrafen 400mg, Gen İlaç) immediately after intubation and intravenous Paracetamol 1000mg (Parol, Atabay Kimya Sanayi) and Tramadol before extubation to contribute to postoperative analgesia 100 mg (Contramal, Abdi İbrahim İlaç Sanayi) will be administered. In addition, ondansetron (Zofer 4mg, Adeka) (4mg) will be administered for postoperative nausea and vomiting (PONV) prophylaxis.

A rectus sheath block will be applied to one group by randomization in the computer environment, and a fascial plane block will be applied to the other group. At the end of the operation, the anesthesiologist was dressed sterile before the extubation. Surgical drapes and blocks were applied in the supine position without disturbing the sterile environment. Ultrasound and liner probe was covered with a sterile drape. Rectus block, wide bandwidth, high-frequency linear probe (4-12 Mhz) (GE, LOGIQ P9 R3, Seongnam-si, Republic of Korea) and 22 Gauge, 80 mm, insulated facet needle (Pajunk GmbH, Geisingen, Germany) ) was planned. For the rectus sheath block (RB), the ultrasound probe is placed transversely at the level of the umbilicus. The rectus abdominis muscle and fascia transversalis are displayed. The needle is placed on the ultrasound probe from the lateral to the medial by in-plane technique and placed between the posterior sheath of the rectus muscle and the fascia transversalis. 20 ml of 0.25% Bupivacaine plaine (MArcaine, Sanofi İlaç A.Ş, Turkey) is administered after the fascial spread is observed under the rectus abdominis muscle using the hydro dissection technique with saline. For RB, the same procedure is applied to the other parties.

After the patients are extubated, they will be taken to the recovery unit and followed up at 0,10,30, and 60 minutes in pain scores, nausea, vomiting, and other side effects. The pain scores (postoperative pain and urethral catheter-related pain) of the patients transferred from the recovery unit to the service floor will be recorded at the 3rd hour, 6th hour, 12th hour, and 24th hour. To contribute to multimodal analgesia in service follow-ups, intravenous Paracetamol 1000 mg (Parol, Atabay Kimya Sanayi) 3*1 and ibuprofen (Intrafen 400mg, Gene İlaç) 2x400mg will be administered.

Recovery unit (PACU) follow-up; Pain scores of all patients will be recorded at 0, 30, and 60 minutes by blind nurses for the study groups. Patients with NRS scores ≥ 4 will receive 25 µg of fentanyl. Patients with NRS scores ≥ 7 will receive 50 µg of fentanyl. Once NRS scores continue as indicated, fentanyl will be repeated at the same dose at relevant times. The total fentanyl dose requirement in the PACU will be recorded. The PACU unit will record side effects such as nausea, difficulty breathing, and tremors. Urethral catheter pain will also be questioned and recorded at the relevant specified times in the PACU unit. Intravenous morphine patient-controlled analgesia (PCA) will be started in all patients. PCA doses will be adjusted for all patients with only a bolus dose of 1 mg with a 7 min lock time. PCA bolus dose used during the PACU period will be recorded. Patients will be given pain score information for PCA use and instructed to press the bolus button if their pain is four or more.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 21, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• Age between 18 - 79, the patients who will undergo robotic prostatectomy surgeries

Exclusion Criteria:

• Presence of a condition preventing facial plane nerve block

• Coagulopathies

• Chronic opioid use

• Stroke

• Polyneuropathy

• Patients with cognitive dysfunction

• Communication difficulties

• Alzheimer's

• Dementia

• Patients who are allergic to the drugs to be used

Related Conditions & MeSH terms

• Prostatectomy

Intervention

Procedure:
• Robotic prostatectomy
patients who will undergo robotic prostatectomy

Locations

Country	Name	City	State
Turkey	Amerikan Hastanesi	Istanbul
Turkey	Koç Üniversitesi	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
V.K.V. American Hospital, Istanbul

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Chiancone F, Fabiano M, Ferraiuolo M, de Rosa L, Prisco E, Fedelini M, Meccariello C, Visciola G, Fedelini P. Clinical implications of transversus abdominis plane block (TAP-block) for robot assisted laparoscopic radical prostatectomy: A single-institute analysis. Urologia. 2021 Feb;88(1):25-29. doi: 10.1177/0391560320957226. Epub 2020 Sep 18. — View Citation

Desai N, El-Boghdadly K, Albrecht E. Epidural vs. transversus abdominis plane block for abdominal surgery - a systematic review, meta-analysis and trial sequential analysis. Anaesthesia. 2021 Jan;76(1):101-117. doi: 10.1111/anae.15068. Epub 2020 May 8. — View Citation

Schiffmann J, Larcher A, Sun M, Tian Z, Berdugo J, Leva I, Widmer H, Lattouf JB, Zorn K, Haese A, Shariat SF, Saad F, Montorsi F, Graefen M, Karakiewicz PI. Differences in Patient Characteristics among Men Choosing Open or Robot-Assisted Radical Prostatectomy in Contemporary Practice - Analysis of Surveillance, Epidemiology, and End Results Database. Urol Int. 2017;98(1):40-48. doi: 10.1159/000447495. Epub 2016 Aug 4. — View Citation

Tran DQ, Bravo D, Leurcharusmee P, Neal JM. Transversus Abdominis Plane Block: A Narrative Review. Anesthesiology. 2019 Nov;131(5):1166-1190. doi: 10.1097/ALN.0000000000002842. — View Citation

Woldu SL, Weinberg AC, Bergman A, Shapiro EY, Korets R, Motamedinia P, Badani KK. Pain and analgesic use after robot-assisted radical prostatectomy. J Endourol. 2014 May;28(5):544-8. doi: 10.1089/end.2013.0783. Epub 2014 Jan 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain and postoperative morphine consumption	The effect of rectus sheath block on postoperative pain scores and morphine consumption in patients undergoing robotic prostatectomy will be investigated.	postoperative 0 - 48 hours
Secondary	urethral catheter pain	The effect of rectus sheath block on urethral catheter pain in robotic prostatectomy operations will be investigated.	postoperative 0 - 48 hours