Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06095908
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2023-10-06
Brief Title:
The Effect of Bilateral Rectus Sheath Block Versus Wound Infiltration in Gynecooncological Patients
Sponsor:
Dr Lutfi Kirdar Kartal Training and Research Hospital
Organization:
Dr Lutfi Kirdar Kartal Training and Research Hospital
Study Overview
Official Title:
The Effect of Ultrasound-Guided Bilateral Rectus Sheath Block Versus Wound Infiltration on Postoperative Pain in Gynecooncological Patients Undergoing Laparotomy With Midline Incision Randomized Controlled Triple Blinding Study
Status:
COMPLETED
Status Verified Date:
2024-05
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:
Postoperative pain is a serious problem in gynecological oncology patients who underwent median vertical incision The aim of our study is to compare ultrasound guided bilateral rectus sheath block and local anesthetic wound infiltration application in postoperative pain control
Detailed Description:
This single-center prospectiveobservational study was approved by Institutional Ethics Committee Decision number 202351425731 Date 29052023 and was performed in accordance with the Declaration of Helsinki Between June and September 2023 ultrasound guided bilateral rectus sheath block or local anesthesia administered to the patients in the gynecological oncology operating room of the University of Health Sciences Kartal Dr Lutfi Kırdar City Hospital at the end of the surgery In the postoperative period the pain level of the patients was recorded with the numerical rating scale at 2 6 12 and 24 hours by an anesthesiologist who was unaware of the application The data were entered into the table by an anesthesiologist who did not know which application was performed Thus data were recorded using a randomized triple blinding method in which the patient the researcher and the recording staff were blinded
All patients underwent preoperative evaluation one day before surgery and written informed consent was obtained for participation for the study The procedure to be performed on the patients was planned in accordance with the randomization made by the statistician The anesthesiologist who would perform the intervention participated in the study blindly to the drugs and groups Patients in Group I underwent postoperative ultrasound-guided bilateral rectus sheath block at the T9-10 level with 20 ml of 025 bupivacaine 40 ml in total For the patients in Group II control group 20 ml of 025 bupivacaine was applied subcutaneously to each wound lip 40 ml in total At the end of the surgery 100 mg tramadol iv and paracetamol 1mgkg iv were administered to both groups as analgesics
Pain ranging from 0 no pain to 10 worst imaginable was queried by another anesthesiologist who was blind to the procedure 21 non-steroidal anti-inflammatory was routinely administered as an analgesic in the ward but the first application time was planned by questioning the patients pain Rescue analgesia with tramadol was administered if the patient ranged the pain 4 Pain was measured at the 2nd 6th 12th and 24th hours postoperatively and tramadol consumption was recorded
All patients underwent preoperative evaluation one day before surgery and written informed consent was obtained for participation for the study The procedure to be performed on the patients was planned in accordance with the randomization made by the statistician The anesthesiologist who would perform the intervention participated in the study blindly to the drugs and groups Patients in Group I underwent postoperative ultrasound-guided bilateral rectus sheath block at the T9-10 level with 20 ml of 025 bupivacaine 40 ml in total For the patients in Group II control group 20 ml of 025 bupivacaine was applied subcutaneously to each wound lip 40 ml in total At the end of the surgery 100 mg tramadol iv and paracetamol 1mgkg iv were administered to both groups as analgesics
Pain ranging from 0 no pain to 10 worst imaginable was queried by another anesthesiologist who was blind to the procedure 21 non-steroidal anti-inflammatory was routinely administered as an analgesic in the ward but the first application time was planned by questioning the patients pain Rescue analgesia with tramadol was administered if the patient ranged the pain 4 Pain was measured at the 2nd 6th 12th and 24th hours postoperatively and tramadol consumption was recorded
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