Comparison of Analgesic Effects of TAP Block and RSB in RALPs

Comparison of Analgesic Effects of Subcostal Transversus Abdominis Plane Block and Rectus Sheath Block in Robotic-Assisted Laparoscopic Prostatectomies

In this research, we aim to compare the postoperative analgesic efficacy of these two peripheral blocks in patients undergoing RALP who have received preoperative TAP block and RSB block.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Other: TAP Block; Other: RSB

Detailed Description

"Robotic-assisted laparoscopic prostatectomy (RALP) is a minimally invasive and superior technique that provides better visualization and maneuverability compared to open and laparoscopic surgical techniques. Previous studies have shown that RALP offers better postoperative oncological and physiological outcomes compared to open and laparoscopic techniques. However, RALP patients still experience pain lasting for several days postoperatively, which requires the use of analgesics such as opioids. This pain is associated with port site incisions, dissection of the prostate and surrounding tissues, bladder spasms, and transurethral catheter irritation. For this purpose, previous studies have utilized central and peripheral methods to reduce postoperative pain. Previous studies have demonstrated the analgesic benefits of TAP block and rectus sheath block in robotic-assisted radical prostatectomies. However, the number of studies in this area is limited. In this research, we aim to compare the postoperative analgesic efficacy of these two peripheral blocks in patients undergoing RALP who have received preoperative TAP block and RSB block.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Zeynep Koc; Phone Number: +905345958843; Email: zeynepyilmazkoc@hotmail.com

Study Locations

• Turkey
  • Ankara
    • Yenimahalle, Ankara, Turkey
      • Zeynep Koç

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18-79 who underwent robotic radical prostatectomy and have ASA (American Society of Anesthesiologists) physical status score of 1-3.

Description

Inclusion Criteria:

• Patients aged 18-79 who underwent robotic radical prostatectomy
• Patients have ASA (American Society of Anesthesiologists) physical status score of 1-3.

Exclusion Criteria:

• Patients with an allergy to local anesthetic agents
• a platelet count below 100,000
• INR value above 2

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TAP Group; TAP block will be performed immediately after the induction of anesthesia, under ultrasond guidence.	Other: TAP Block; TAP block will be performed immediately after the induction of anesthesia, under ultrasond guidence.
RSB Group; RSB block will be performed immediately after the induction of anesthesia, under ultrasond guidence.	Other: RSB; Rectus Sheath block will be performed immediately after the induction of anesthesia, under Ultrasond guidence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operatif analgesia consumption	postoperative iv-PCA tramadole dose for the first 24 hours from iv-PCA devices.	postoperative 24 hous

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
numerical rating scale (NRS) at rest	Recording the patient's pain at rest on the Numerical Rating Scale (NRS) by asking the patient	popstoperative 1. hour
numerical rating scale (NRS) at rest	Recording the patient's pain at rest on the Numerical Rating Scale (NRS) by asking the patient	postoperative 6. hour
numerical rating scale (NRS) at rest	Recording the patient's pain at rest on the Numerical Rating Scale (NRS) by asking the patient	postoperative 16. hour
numerical rating scale (NRS) at rest	Recording the patient's pain at rest on the Numerical Rating Scale (NRS) by asking the patient	postoperative 24. hour
NRS during coughing	The NRS for pain during coughing will be recorded by asking the patient	postoperative1. hour
NRS during coughing	The NRS for pain during coughing will be recorded by asking the patient	postoperative 6. hour
NRS during coughing	The NRS for pain during coughing will be recorded by asking the patient	postoperative 16. hour
NRS during coughing	The NRS for pain during coughing will be recorded by asking the patient	postoperative24. hour
postoperative nosia and vomiting (PONV)	Recording the presence or absence of nausea and vomiting in the patient within the first 24 hours postoperatively	postoperative 24 hours

Collaborators and Investigators

• Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital

Publications and helpful links

General Publications

• Taninishi H, Matsusaki T, Morimatsu H. Transversus Abdominis Plane Block Reduced Early Postoperative Pain after Robot-assisted Prostatectomy: a Randomized Controlled Trial. Sci Rep. 2020 Feb 28;10(1):3761. doi: 10.1038/s41598-020-60687-y.
• Beilstein CM, Huber M, Furrer MA, Loffel LM, Wuethrich PY, Engel D. Impact of analgesic techniques on early quality of recovery after prostatectomy: A 3-arm, randomized trial. Eur J Pain. 2022 Oct;26(9):1990-2002. doi: 10.1002/ejp.2020. Epub 2022 Aug 21.
• Cosarcan SK, Gurkan Y, Manici M, Ozdemir I, Kilic M, Esen T, Ercelen O. The effect of ultrasound-guided rectus sheath block on postoperative analgesia in robot assisted prostatectomy: A randomized controlled trial. Medicine (Baltimore). 2024 Apr 26;103(17):e37975. doi: 10.1097/MD.0000000000037975.

Study record dates

Study Major Dates

• Study Start (Estimated): November 20, 2024
• Primary Completion (Estimated): January 20, 2025
• Study Completion (Estimated): January 30, 2025

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: November 7, 2024
• First Posted (Estimated): November 8, 2024

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: transversus abdominis plane block; Rectus sheath block; Robot-assisted laparoscopic prostatectomy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative
• Other Study ID Numbers: ZeynepKoc002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No