External Oblique Intercostal Plane Block for Laparoscopic Sleeve Gastrectomy

• Sponsor: Istinye University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05663658
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4.2
• Patients Per Site Per Month: 14.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Analgesia; Postoperative Pain	Other: Intravenous morphine patient control device; Other: External oblique intercostal plane block	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: External Oblique Intercostal Plane Block for Postoperative Analgesia in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy
• Actual Study Start Date: Dec 23, 2022
• Anticipated Primary Completion Date: Mar 31, 2023
• Anticipated Study Completion Date: Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control group The patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia	Other: Intravenous morphine patient control device; 24-hour morphine consumption will be recorded
Active Comparator: External oblique intercostal plane block group The patients in external oblique intercostal plane block group will be received EOI plane block and patient controlled analgesia with morphine for postoperative analgesia	Other: Intravenous morphine patient control device; 24-hour morphine consumption will be recorded; Other: External oblique intercostal plane block; External oblique intercostal plane block will be administered before the surgery.

Outcome Measures

Primary Outcome Measures

1. Morphine consumption [Postoperative 24 hours]

   The amount of morphine required by the patient and given by the device will be recorded for the first 24 hours.

Secondary Outcome Measures

1. Postoperative visual analog scale scores [Postoperative 24 hours]

   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.

2. Time to first rescue analgesic [postoperative 24 hours]

   The time for administration of first rescue analgesic will be recorded.

3. Rescue analgesic drug consumption [postoperative 24 hours]

   The amount of rescue analgesic in mg required by the patient will be recorded for the first 24 hours.

4. Incidence of postoperative nausea and vomiting [postoperative 24 hours]

   Number of patients developing postoperative nausea and vomiting will be recorded for the first 24 hours

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istinye University Hospital	Istanbul		Turkey

Sponsors and Collaborators

• Istinye University

Investigators

• Principal Investigator: Ali Sait Kavakli, M.D., Istinye University
• Principal Investigator: Taylan Sahin, M.D., Istinye University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Istinye University
• ClinicalTrials.gov Identifier: NCT05663658
• Other Study ID Numbers: anestezi1
• First Posted: Dec 23, 2022
• Last Update Posted: Jan 10, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative; Morphine

Study Results

No Results Posted as of Jan 10, 2023