Clinical trial NCT06681571: Comparison of Analgesic Effects of TAP Block and RSB in RALPs
Official title: Comparison of Analgesic Effects of Subcostal Transversus Abdominis Plane Block and Rectus Sheath Block in Robotic-Assisted Laparoscopic Prostatectomies
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Postoperative Pain
Keywords: transversus abdominis plane block
Rectus sheath block
Robot-assisted laparoscopic prostatectomy
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-11-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: post operatif analgesia consumption
timeFrame: postoperative 24 hous
Secondary outcomes:
measure: numerical rating scale (NRS) at rest
timeFrame: popstoperative 1. hour
measure: numerical rating scale (NRS) at rest
timeFrame: postoperative 6. hour
measure: numerical rating scale (NRS) at rest
timeFrame: postoperative 16. hour
measure: numerical rating scale (NRS) at rest
timeFrame: postoperative 24. hour
measure: NRS during coughing
timeFrame: postoperative1. hour
measure: NRS during coughing
timeFrame: postoperative 6. hour
measure: NRS during coughing
timeFrame: postoperative 16. hour
measure: NRS during coughing
timeFrame: postoperative24. hour
measure: postoperative nosia and vomiting (PONV)
timeFrame: postoperative 24 hours
Other outcomes:
Locations:
city: Yenimahalle
country: Turkey
facility: Zeynep Koç
state: Ankara
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.