Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321185
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-14
Brief Title:
Laparoscopic Cholecystectomy and Quality of Recovery
Sponsor:
Istanbul University
Organization:
Istanbul University
Study Overview
Official Title:
The Effects of Subcostal Transversus Abdominis Plane Block and Port-site Infiltration on the Quality of Recovery of Patients Undergoing Laparoscopic Cholecystectomy
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial aims to compare the Quality of Recovery-15 QoR-15 scale scores in three groups of patients undergoing laparoscopic cholecystectomy The first group will be applied subcostal transversus abdominis plane subcostal TAP block the second group will receive local anesthetic infiltration into port sites and the third group will receive only IV analgesics
Detailed Description:
There are current approaches that search patients perspectives to assess postoperative outcomes In this regard patient-centered outcomes are evaluated in clinical trials It is recommended that patient comfort be assessed for short-term recovery after surgery The Quality of Recovery-15 QoR-15 scale is a defined patient comfort endpoint This scale is a 15-item questionnaire that evaluates postoperative recovery as a patient-centered outcome Each item is rated between 1 and 10 and the total score changes between 0 and 150 Improved recovery is associated with higher scores
The subcostal transversus abdominis plane Subcostal TAP block is used for analgesia in abdominal surgeries including laparoscopic cholecystectomy Local anesthetics are injected between the rectus abdominis and transversus abdominis muscles along the oblique subcostal line Local anesthetic infiltration into the laparoscopic port sites is also used for analgesia in laparoscopic cholecystectomy
The primary outcome of this study is to evaluate the effects of subcostal TAP block and port-site infiltration on the quality of recovery of patients undergoing laparoscopic cholecystectomy Secondary outcomes are to evaluate Numerical Rating Scale NRS scores at time intervals postoperative rescue analgesic requirement total consumption of postoperative opioid analgesics and presence of nausea and vomiting for the postoperative 24 hours
This study will be conducted as a prospective randomized clinical trial The patients scheduled for elective laparoscopic cholecystectomy will be screened for enrollment in the study After assessment for eligibility the patients will be randomly allocated into three groups
For the first group a subcostal TAP block will be applied after intubation and before surgery A local anesthetic solution of 20 ml 025 bupivacaine for each side will be injected bilaterally between the rectus abdominis and transversus abdominis muscles along the oblique subcostal line For the second group after intubation and before port placements a solution of 20 ml 025 bupivacaine will be infiltrated into the laparoscopic port sites The third group will not have an intervention or local anesthetic administration and a multimodal routine IV analgesic regimen will be administered intraoperatively 1 gr paracetamol 8 mg lornoxicam and 1mgkg tramadol This IV analgesic regimen will be applied to all patients included in the study The patients will not know to which group they are allocated Standard anesthesia protocol will be applied to all patients
At the ward patients will receive a standard postoperative multimodal analgesia protocol comprising paracetamol and lornoxicam At the Numerical Rating Scale NRS pain is rated on a scale from 0 no pain to 10 worst pain and will be assessed at time intervals both at rest and during movement for postoperative 24 hours A rescue analgesic IV 50 mg tramadol will be applied if it is four or higher The healthcare provider will be blinded to which group the patient is in All NRS scores the requirement for rescue analgesics and total consumption and the presence of nausea and vomiting for the postoperative 24 hours will be recorded by blind outcome assessors
The Quality of Recovery-15 QoR-15 scale will be evaluated before the surgery in the waiting area and at the postoperative 24th hour in the ward The outcome assessor questioning QoR-15 will be blinded to which group the patient is allocated to
The subcostal transversus abdominis plane Subcostal TAP block is used for analgesia in abdominal surgeries including laparoscopic cholecystectomy Local anesthetics are injected between the rectus abdominis and transversus abdominis muscles along the oblique subcostal line Local anesthetic infiltration into the laparoscopic port sites is also used for analgesia in laparoscopic cholecystectomy
The primary outcome of this study is to evaluate the effects of subcostal TAP block and port-site infiltration on the quality of recovery of patients undergoing laparoscopic cholecystectomy Secondary outcomes are to evaluate Numerical Rating Scale NRS scores at time intervals postoperative rescue analgesic requirement total consumption of postoperative opioid analgesics and presence of nausea and vomiting for the postoperative 24 hours
This study will be conducted as a prospective randomized clinical trial The patients scheduled for elective laparoscopic cholecystectomy will be screened for enrollment in the study After assessment for eligibility the patients will be randomly allocated into three groups
For the first group a subcostal TAP block will be applied after intubation and before surgery A local anesthetic solution of 20 ml 025 bupivacaine for each side will be injected bilaterally between the rectus abdominis and transversus abdominis muscles along the oblique subcostal line For the second group after intubation and before port placements a solution of 20 ml 025 bupivacaine will be infiltrated into the laparoscopic port sites The third group will not have an intervention or local anesthetic administration and a multimodal routine IV analgesic regimen will be administered intraoperatively 1 gr paracetamol 8 mg lornoxicam and 1mgkg tramadol This IV analgesic regimen will be applied to all patients included in the study The patients will not know to which group they are allocated Standard anesthesia protocol will be applied to all patients
At the ward patients will receive a standard postoperative multimodal analgesia protocol comprising paracetamol and lornoxicam At the Numerical Rating Scale NRS pain is rated on a scale from 0 no pain to 10 worst pain and will be assessed at time intervals both at rest and during movement for postoperative 24 hours A rescue analgesic IV 50 mg tramadol will be applied if it is four or higher The healthcare provider will be blinded to which group the patient is in All NRS scores the requirement for rescue analgesics and total consumption and the presence of nausea and vomiting for the postoperative 24 hours will be recorded by blind outcome assessors
The Quality of Recovery-15 QoR-15 scale will be evaluated before the surgery in the waiting area and at the postoperative 24th hour in the ward The outcome assessor questioning QoR-15 will be blinded to which group the patient is allocated to
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None