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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-incisional Block Group | Experimental | Participants receive ultrasound-guided subcostal transversus abdominis plane (TAP) block combined with rectus sheath block (RSB) after induction of general anesthesia and before surgical incision. |
|
| Postoperative Block Group | Experimental | Participants receive ultrasound-guided subcostal transversus abdominis plane (TAP) block combined with rectus sheath block (RSB) after completion of surgery and before emergence from anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-guided subcostal TAP block combined with rectus sheath block | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum postoperative pain intensity within 24 hours | 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. | Within 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum postoperative pain intensity during 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. | During the post-anesthesia care unit stay |
| Cumulative rescue opioid consumption within 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hye-Yeon Cho, MD | Contact | +82-2-970-8705 | anesthesia_chy@eulji.ac.kr | |
| Soojeong Kang, MD | Contact | +82-2-970-8705 | 20260034@eulji.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Hye-yeon Cho | Nowon Eulji University Hospital, Eulji University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nowon Eulji University Hospital | Recruiting | Seoul | 01830 | South Korea |
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Participants will be randomly assigned in a 1:1 ratio to receive the combined ultrasound-guided subcostal TAP block and rectus sheath block either before surgical incision or after completion of surgery.
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Participants and outcome assessors will be blinded to group allocation. The anesthesiologist performing the block will not be blinded due to the nature of the intervention.
|
Total amount of rescue opioid administered between 1 and 24 hours after surgery. |
| Within 24 hours after surgery |
| Incidence of postoperative nausea and vomiting | Occurrence of nausea or vomiting during the postoperative period. | Within 24 hours after surgery |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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