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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Bupivacain

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Turkey
  • Kartal
    • Istanbul, Kartal, Turkey
      • Kartal Dr Lutfi Kırdar City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Between June and October 2023, 60 patients aged ASA II-III, 18-65 years old, who will undergo elective gynecooncological surgery with median incision will participate in the study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
'rectus sheath block'; Patients in Group I underwent postoperative USG-guided bilateral rectus sheath block at the T9-10 level with 20 ml of 0.25% bupivacaine (40 ml in total).	Drug: Bupivacain; Bupivacain administered with two different ways to the patients, postoperative pain recorded
'wound infiltration'; Group II (control group), 20 ml of 0.25% bupivacaine was applied subcutaneously to each wound lip (40 ml in total).	Drug: Bupivacain; Bupivacain administered with two different ways to the patients, postoperative pain recorded

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Actual): November 25, 2023
• Study Completion (Actual): November 25, 2023

Study Registration Dates

• First Submitted: October 6, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: postoperative pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: DrLutfiKirdarANESTESIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No