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Not yet recruiting NCT06681571

Comparison of Analgesic Effects of TAP Block and RSB in RALPs

Observational Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TAP Block, RSB.
Who it may be relevant to
Registry conditions: Postoperative Pain. Basic parameters: 18 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other TAP Block
    TAP 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.

Primary outcome measures

  • post operatif analgesia consumption [Time frame: postoperative 24 hous]
Secondary outcome measures (9)
  • numerical rating scale (NRS) at rest [Time frame: popstoperative 1. hour]
  • numerical rating scale (NRS) at rest [Time frame: postoperative 6. hour]
  • numerical rating scale (NRS) at rest [Time frame: postoperative 16. hour]
  • numerical rating scale (NRS) at rest [Time frame: postoperative 24. hour]
  • NRS during coughing [Time frame: postoperative1. hour]
  • NRS during coughing [Time frame: postoperative 6. hour]
  • NRS during coughing [Time frame: postoperative 16. hour]
  • NRS during coughing [Time frame: postoperative24. hour]
  • postoperative nosia and vomiting (PONV) [Time frame: postoperative 24 hours]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Turkey (Türkiye) · 1 center
  • Zeynep Koç — Yenimahalle

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. PMID 32111916
  • 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. PMID 35960649
  • 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. PMID 38669407

Identifiers

NCT: NCT06681571 · ZeynepKoc002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗