Comparison of the Application of Lidocaine With Intraperitoneal Bupivacaine in Cesarian Operations Wound Infiltration

NCT04856735 | Unknown

• 1 other identifier: B.30.2.ATA.0.01.00/384
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain control is important to reduce morbidity and mortality, and this becomes even more important after cesarean delivery. Severe postpartum pain is associated with chronic pain, and the mother faces a 2.5-fold increased risk of chronic pain and a 3-fold increased risk of postpartum depression compared to mild ones Postoperative pain management is more difficult in the postpartum period. Because the main analgesics used are opioids that are excreted from milk and the newborn may be exposed to the side effects of these drugs . Therefore, multimodal approach is recommended in pain management. Surgical wound infiltration (LWI) of local anesthetics is an important component of multimodal analgesia . Some of the pain from surgery is caused by an inflammatory response to the surgical incision; therefore, reducing this inflammation can provide a better analgesia and also minimize side effects . Ease of use and safety of intraperitoneal local anesthetics (IPLA) has been demonstrated in studies and has become a useful alternative to opioid-based analgesic regimens for the treatment of acute postoperative pain. Investigators aim is to compare the effectiveness of LWI and IPLA applications on postoperative analgesia in women undergoing elective cesarean delivery under spinal anesthesia (SA). Investigators hypothesis, H0, was that there was no statistically significant difference between the three groups in the mean postoperative pain scores at the 24th hour during movement. H1 was a statistically significant difference between the mean postoperative pain scores at the 24th hour during the movement between the three groups. The primary aim of the study was pain scores during the postoperative 24th hour mobilization. Secondary outcome was total fentanyl consumption (µg) in the first postoperative 24 hours

Conditions

Postoperative Pain; Cesarean Section

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  The primary outcome in this study is visual analog scores (VAS scores 0 to 10) during mobilization postoperative 24th hour. Higher scores mean a worse outcome.

  24th hours

Secondary Outcomes (1)

• patient satisfaction

  24th hours

Study Arms (3)

IPLA:intraperitoneal local anesthetic

ACTIVE COMPARATOR

intraperitoneal local anesthetic:after the birth of the newborn and placenta, the uterus is closed and the blood accumulated in the pelvis is carefully wiped with surgical towels, after hemostasis is fully achieved, a total of 20 ml solution containing 10 cc of 0.5% bupivacaine +10 cc 2% lidocaine and 2 injectors containing 20ml saline and the 20ml solution were given to the surgeon. The 20 ml solution containing bupivacaine and lidocaine was injected into the uterine peritoneal region by spraying 5 mL to each quadrant of the uterus before closing the parietal peritoneum or fascia. The parietal peritoneal layer was sutured or left open at the surgeon's preference. At the end of the operation, 20 ml of saline solution was applied subcutaneously in the form of LWI instead of the incision before the skin was closed.

Other: Intraperİtoneal local anaesthesİc İn cesarean sectİon

LWI:Surgical wound infiltration

ACTIVE COMPARATOR

Surgical wound infiltration:a solution containing 20 ml of saline was added to all four quadrants of the uterus in 5 ml volume and 20 ml solution containing lidocaine and bupivacaine were subcutaneously in the form of LWI before the skin was closed.

Other: Local wound infiltrasyon

C: CONTROL GROUP

ACTIVE COMPARATOR

one of the two sterile injectors containing 20 ml of saline was applied to the uterine peritoneal region and the other was applied to the incision area as a local subcutaneous wound infiltration.

Other: Control group

Interventions

Intraperİtoneal local anaesthesİc İn cesarean sectİon OTHER

After the birth of the newborn and placenta, the uterus is closed and the blood accumulated in the pelvis is carefully wiped with surgical towels, after hemostasis is fully achieved, a total of 20 ml solution containing 10 cc of 0.5% bupivacaine +10 cc 2% lidocaine and 2 injectors containing 20ml saline and the 20ml solution were given to the surgeon area.

Also known as: IPLA

IPLA:intraperitoneal local anesthetic

Local wound infiltrasyon OTHER

A solution containing 20 ml of saline was added to all four quadrants of the uterus in 5 ml volume and 20 ml solution containing lidocaine and bupivacaine were subcutaneously in the form of LWI before the skin was closed

Also known as: LWI

LWI:Surgical wound infiltration

Control group OTHER

One of the two sterile injectors containing 20 ml of saline was applied to the uterine peritoneal region and the other was applied to the incision area as a local subcutaneous wound infiltration.

Also known as: C

C: CONTROL GROUP

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: pregnant woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women
• years
• ASA I-II,
• ≥34th gestational week

You may not qualify if:

• Patients with neuraxial anesthesia contraindications
• Patients allergic to drugs to be used in the study
• BMI\> 35 kg / m2
• Diabetes, preeclampsia, cardiovascular disease, chronic pain and neuropathic pain
• Patients who have been given opioids in operation due to intraoperative pain
• Patients with unsuccessful spinal anesthesia who underwent general anesthesia
• Patients with excessive bleeding during the operation, uterine atony, placement of the drain in the area to be infiltrated
• Patients who do not want spinal anesthesia,
• Cannot understand VAS
• History of drug addiction and psychiatric illness

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, 25100, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• Betran AP, Merialdi M, Lauer JA, Bing-Shun W, Thomas J, Van Look P, Wagner M. Rates of caesarean section: analysis of global, regional and national estimates. Paediatr Perinat Epidemiol. 2007 Mar;21(2):98-113. doi: 10.1111/j.1365-3016.2007.00786.x.

  PMID: 17302638 BACKGROUND

• Klaus MH, Kennell JH, Plumb N, Zuehlke S. Human maternal behavior at the first contact with her young. Pediatrics. 1970 Aug;46(2):187-92. No abstract available.

  PMID: 5432150 BACKGROUND

• Nikolajsen L, Sorensen HC, Jensen TS, Kehlet H. Chronic pain following Caesarean section. Acta Anaesthesiol Scand. 2004 Jan;48(1):111-6. doi: 10.1111/j.1399-6576.2004.00271.x.

  PMID: 14674981 BACKGROUND

• Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.

  PMID: 18818022 BACKGROUND

• Dahl JB, Jeppesen IS, Jorgensen H, Wetterslev J, Moiniche S. Intraoperative and postoperative analgesic efficacy and adverse effects of intrathecal opioids in patients undergoing cesarean section with spinal anesthesia: a qualitative and quantitative systematic review of randomized controlled trials. Anesthesiology. 1999 Dec;91(6):1919-27. doi: 10.1097/00000542-199912000-00045. No abstract available.

  PMID: 10598635 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Cesarean Section; Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• AYŞENUR DOSTBİL, MD

  Ataturk University

  STUDY DIRECTOR

Central Study Contacts

GÖZDENUR DAĞAŞAN, MD

CONTACT

+905053218845; gozdenurdagasan25@gmail.com

AYŞENUR DOSTBİL, MD

CONTACT

+905333676696; adostbil@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 23, 2021
• Study Start: October 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: April 23, 2021

Record last verified: 2021-04

Locations

TU (1)