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NCT05769881
Effects of Subcostal TAP Block and Local Anesthetic Infiltration After Laparoscopic Cholecystectomy
NA trial testing Ultrasound guided subcostal transversus abdominis plane block in Postoperative Pain in 70 participants. Completed in 13 December 2023.
4 December 2023
Quick facts
| Lead sponsor | Sisli Hamidiye Etfal Training and Research Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 25 July 2023 |
| Primary completion | 4 December 2023 |
| Estimated completion | 13 December 2023 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Ultrasound guided subcostal transversus abdominis plane block
- Wound site local anesthetic infiltration
Conditions studied
- Postoperative Pain — all drugs for Postoperative Pain →
- Subcostal Transversus Abdominis Plane Block — all drugs for Subcostal Transversus Abdominis Plane Block →
- Gall Bladder Disease — all drugs for Gall Bladder Disease →
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
Who can join
Adults 18 to 65, any sex, with Postoperative Pain or Subcostal Transversus Abdominis Plane Block. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Laparoscopic cholecystectomy surgery is an intra-abdominal surgery that is frequently used in the treatment of gallbladder-related pathologies. Compared to open surgery, the cost, the risk of bleeding, the risk of surgical site infection are lower, the need for hospitalization is shorter, and the recovery is rapid. Adequate pain relief is very important after laparoscopic cholecystectomy. Inadequate analgesia in post-operative period has been associated with pain-related cognitive dysfunction, atelectasis, thromboembolic events, increased surgery-related stress response, prolonged hospital stay, and chronic pain in patients. Acetaminophen, non-steroidal anti-inflammatory drugs, opioid analgesics, intraperitoneal washing, local anesthesia infiltration and various regional anesthesia techniques can be used for appropriate analgesia. Studies have shown that subcostal transversus abdominis block has good analgesic efficacy in laparoscopic cholecystectomy surgeries. In the perioperative and postoperative period, afferent nerve signals in the surgical incision area stimulate the hypothalamus, causing the release of CRH, arginine vasopressin, and cortisol depending on the size of the surgical procedure. Providing patients with appropriate postoperative analgesia reduces the release of the stress hormones cortisol and prolactin. In this study, the investigators are aiming to compare the post-operative analgesic affects and stress hormone responses of subcostal transversus abdominis plane block and local anesthetic infiltration in patients undergoing laparoscopic surgery. The study is planned to be prospective, randomized and single-blind.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05769881
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05769881 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sisli Hamidiye Etfal Training and Research Hospital
- Last refreshed: 19 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05769881.
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