The Effect of Bilateral Rectus Sheath Block Versus Wound Infiltration in Gynecooncological Patients

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06095908
• Other study ID #: DrLutfiKirdarANESTESIA
• Status: Completed
• Start date: June 15, 2023
• Est. completion date: November 25, 2023

Study information

• Verified date: May 2024
• Source: Dr. Lutfi Kirdar Kartal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

This single-center prospective,observational study was approved by Institutional Ethics Committee (Decision number: 2023/514/257/31, Date: 29/05/2023) 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 0.25% bupivacaine (40 ml in total). For the patients in Group II (control group), 20 ml of 0.25% bupivacaine was applied subcutaneously to each wound lip (40 ml in total). At the end of the surgery, 100 mg tramadol iv and paracetamol 1mg/kg 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. 2*1 non-steroidal anti-inflammatory was routinely administered as an analgesic in the ward, but the first application time was planned by questioning the patient's 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 25, 2023
• Est. primary completion date: November 25, 2023
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• electively gynecooncological surgery patients with median incision

• ASA II-III,

• between 18-65 years

Exclusion Criteria:

• ASA IV and above

• over 65 - under 18 years of age

• previous laparotomy

• allergy to local anesthetics

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Bupivacain
Bupivacain administered with two different ways to the patients, postoperative pain recorded

Locations

Country	Name	City	State
Turkey	Kartal Dr Lutfi Kirdar City Hospital	Istanbul	Kartal

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Lutfi Kirdar Kartal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate patients' postoperative pain	The primary aim of this study is to evaluate and compare the postoperative analgesic effectiveness of bilateral rectus sheath block and wound infiltration in gyneco-oncological patients undergoing laparatomy with midline incision. Numeric rating scale (NRS) of 1-10 used for the assessment of postoperative pain.	postoperative 2,6,12,24 th hours
Secondary	Evaluate patients' total analgesic consumption	The secondary aim of the study was to evaluate the patients in terms of time to total amount of opioid analgesics (mg ) consumed in 24 hours.	postoperative 24 hours