External Oblique Intercostal Plane Block for Laparoscopic Sleeve Gastrectomy

Obesity Clinical Trial

Official title:

External Oblique Intercostal Plane Block for Postoperative Analgesia in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05663658
• Other study ID #: anestezi1
• Status: Completed
• Phase: N/A
• Start date: December 23, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: January 2023
• Source: Istinye University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The external oblique intercostal (EOI) plane block is a novel approach upper abdominal wall analgesia. The EOI plane block can provide dermatomal sensory blockade of T6-T10 at the anterior axillary line and T6-T9 at the midline. It may be used for postoperative analgesia in obese patients because it is superficial and rapidly identifiable and performed in the supine position. the aim of this study is to investigate the postoperative analgesic efficacy of external oblique intercostal plane block in obese patients undergoing laparoscopic sleeve gastrectomy. Researchers will compare the external oblique intercostal plane block group with control group to see if the EOI plane block is effective for postoperative analgesia in patients undergoing sleeve gastrectomy.

Description:

Patients scheduled for elective laparoscopic sleeve gastrectomy will be separated into 2 groups: Control Group and External Oblique Intercostal Plane Block Group. Patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia. Patients in External Oblique Intercostal Plane Block Group will be performed bilateral External Oblique Intercostal Plane Block before the surgery and received patient controlled analgesia with morphine for postoperative analgesia. Morphine consumption for first postoperative 24 hours, visual analog scale scores, time to need for first rescue analgesia, amount of rescue analgesic drug, incidence of postoperative nausea and vomiting will be recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 15, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 80 years
• Patients with American Society of Anesthesiology (ASA) physical status II-III
• Patients scheduled for a laparoscopic sleeve gastrectomy

Exclusion Criteria:

• Allergy to local anesthetics
• Coagulopathy
• Skin infection at the EOI Plane Block area
• Advanced hepatic or renal failure
• Chronic pain syndromes
• Alcohol or drug abuse
• Severe pulmonary and/or cardiovascular disease
• Psychiatric disorders

Related Conditions & MeSH terms

• Analgesia
• Obesity
• Pain, Postoperative
• Postoperative Pain

Intervention

Other:
• Intravenous morphine patient control device
24-hour morphine consumption will be recorded
• External oblique intercostal plane block
External oblique intercostal plane block will be administered before the surgery.

Locations

Country	Name	City	State
Turkey	Istinye University Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istinye University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption	The amount of morphine required by the patient and given by the device will be recorded for the first 24 hours.	Postoperative 24 hours
Secondary	Postoperative visual analog scale scores	Postoperative pain will be assessed using a visual analog scale (VAS) (from 0 = no pain to 10 = maximum possible pain) for the first 24 hours.	Postoperative 24 hours
Secondary	Time to first rescue analgesic	The time for administration of first rescue analgesic will be recorded.	postoperative 24 hours
Secondary	Rescue analgesic drug consumption	The amount of rescue analgesic in mg required by the patient will be recorded for the first 24 hours.	postoperative 24 hours
Secondary	Incidence of postoperative nausea and vomiting	Number of patients developing postoperative nausea and vomiting will be recorded for the first 24 hours	postoperative 24 hours