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

NCT06095908 | Completed

• 1 other identifier: DrLutfiKirdarANESTESIA
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

postoperative pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluate patients' total analgesic consumption

  postoperative 24 hours

Study Arms (2)

'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

'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

Interventions

Bupivacain DRUG

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

'rectus sheath block'; 'wound infiltration'

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• electively gynecooncological surgery patients with median incision
• ASA II-III,
• between 18-65 years

You may not qualify if:

• ASA IV and above
• over 65 - under 18 years of age
• previous laparotomy
• allergy to local anesthetics

Sponsors & Collaborators

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

Study Sites (1)

Kartal Dr Lutfi Kırdar City Hospital

Istanbul, Kartal, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Dr

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 23, 2023
• Study Start: June 15, 2023
• Primary Completion: November 25, 2023
• Study Completion: November 25, 2023
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

TU (1)