Nowon Eulji University Hospital
Seoul, 01830, South Korea
Location status: Recruiting
NCT Number: NCT07440940
This prospective randomized controlled trial aims to evaluate whether the timing of ultrasound-guided subcostal transversus abdominis plane (TAP) block combined with rectus sheath block (RSB) affects postoperative pain in patients undergoing laparoscopic cholecystectomy.
Participants will be randomly assigned to receive the combined regional blocks either before surgical incision or after completion of surgery. The primary outcome is postoperative pain intensity measured using a numerical rating scale. Secondary outcomes include opioid consumption, incidence of postoperative nausea and vomiting, and other recovery parameters.
The results of this study may help optimize the timing of abdominal wall blocks to improve postoperative analgesia and recovery following laparoscopic cholecystectomy.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Seoul, 01830, South Korea
Location status: Recruiting
Postoperative pain after laparoscopic cholecystectomy remains a significant clinical concern despite the minimally invasive nature of the procedure. Ultrasound-guided abdominal wall blocks, including subcostal transversus abdominis plane (TAP) block and rectus sheath block (RSB), are widely used to reduce postoperative pain and opioid requirements. However, the optimal timing of block administration relative to surgical incision remains unclear.
This prospective, single-center, randomized controlled trial will compare the analgesic efficacy of pre-incisional versus post-operative administration of combined ultrasound-guided subcostal TAP block and RSB in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
Participants will be randomized in a 1:1 ratio using block randomization with randomly permuted block sizes. Standardized general anesthesia and postoperative analgesia protocols will be applied to all participants.
The primary outcome will be postoperative pain intensity measured using a numerical rating scale at predefined time points after surgery. Secondary outcomes will include cumulative opioid consumption, incidence of postoperative nausea and vomiting, rescue analgesic requirements, and recovery profiles.
The findings of this study are expected to provide evidence for optimizing the timing of abdominal wall block administration to improve postoperative analgesia and patient recovery after laparoscopic cholecystectomy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound-guided right subcostal transversus abdominis plane (TAP) block combined with bilateral rectus sheath block (RSB) is performed under sterile conditions using local anesthetic for postoperative analgesia.
Time frame: Within 24 hours after surgery
The highest postoperative pain intensity measured using an 11-point numeric rating scale (NRS; 0 = no pain, 10 = worst pain imaginable) during the first 24 hours after surgery, assessed at 1, 6, 12, and 24 hours postoperatively.
Time frame: During the post-anesthesia care unit stay
The highest postoperative pain intensity measured using an 11-point numeric rating scale (NRS; 0 = no pain, 10 = worst pain imaginable) during the recovery period.
Time frame: Within 24 hours after surgery
Total amount of rescue opioid administered between 1 and 24 hours after surgery.
Time frame: Within 24 hours after surgery
Occurrence of nausea or vomiting during the postoperative period.
Contact information is provided by the study sponsor or research team.
Hye-Yeon Cho, MD
CONTACT
Soojeong Kang, MD
CONTACT
Eulji University Hospital
Other
Effect of Timing of Ultrasound-Guided Subcostal Transversus Abdominis Plane Block Combined With Rectus Sheath Block on Postoperative Pain in Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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