M-Tapa Block vs External Oblique Intercostal Block for Laparoscopic Sleeve Gastrectomy Surgery

Postoperative Pain Clinical Trial

Official title:

Bilateral Ultrasound-guided M-Tapa Block vs External Oblique Intercostal Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy Surgery: A Prospective Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05939635
• Other study ID #: MTAPAEOIBLSG2023
• Status: Completed
• Phase: N/A
• Start date: July 11, 2023
• Est. completion date: January 29, 2024

Study information

• Verified date: January 2024
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In obese patients, adequate pain relief in the postoperative period is an important parameter that affects patient comfort and hospital stay. Increasing patient comfort and recovery quality can be achieved by avoiding undesirable effects such as nausea, vomiting, and analgesia. This study aimed to investigate the effects of Bilateral External Oblique Intercostal Block (EOIB) and Perichondrial Modified Thoracoabdominal Nerve Block (M-TAPA) on postoperative acute pain scores (0-24 hours) and 24-hour opioid consumption in patients who underwent laparoscopic sleeve gastrectomy.

Description:

Morbid obesity patients often have multisystem physiological changes and multiple comorbidities that can significantly affect perioperative pain control. These patients may have increased side effects from inadequate acute pain management and opioids should be used with caution. Regional techniques can be applied in obese patients because they provide non-opioid analgesia and have fewer perioperative respiratory side effects. Effective pain control is associated with reduced post-operative opioid administration, faster mobilization, faster recovery, and shorter hospital stay. Intraoperative nerve blocks using local anesthetics have been shown to improve postoperative pain in various abdominal surgeries, both open and laparoscopic. Recently, it has been reported that the M-TAPA block is a promising new technique that provides effective analgesia of the anterior and lateral thoracoabdominal walls during laparoscopic surgery, in which local anesthetic is delivered only to the underside of the perichondral surface. TAPA/M-TAPA block has been shown to provide a potent analgesic effect in a large abdomen by numbing both the anterior and lateral cutaneous branches of the thoracoabdominal nerves. Therefore, the TAPA/M-TAPA block has been used in various abdominal surgeries. The EOI block represents an important modification of the fascial plane block techniques that can consistently cover the upper lateral abdominal wall. When we look at the literature, it is seen that there are not enough studies on M-TAPA block and EOIB. The aim of this study is to investigate the effects of Bilateral External Oblique Intercostal Block (EOIB) and Perichondrial Modified Thoracoabdominal Nerve Block (M-TAPA) on postoperative acute pain scores (0-24 hours) and 24-hour opioid consumption in patients who underwent laparoscopic sleeve gastrectomy. Our study, which the investigators think will contribute to the literature, was planned as a prospective, randomized, controlled, parallel-group study. Patients will be divided into two groups: Group M-TAPA : A bilateral M-TAPA (60 ml 0.25% bupivacaine + 1:400.000 adrenaline) will be performed. In addition, IV morphine-PCA will be applied postoperatively for 24 hours. Group EOIB : A bilateral EOIB (60 ml 0.25% bupivacaine + 1:400.000 adrenaline) will be performed. In addition, IV morphine-PCA will be applied postoperatively for 24 hours.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 29, 2024
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age between18-65 years
• American Society of Anesthesiology score II-III
• Body mass index (BMI) > 35 kg/m2
• Patients who will sign the informed consent form

Exclusion Criteria:

• History of opioid use for more than four weeks
• Chronic pain syndromes
• Patients with a history of local anesthetic or opioid allergy, hypersensitivity
• Severe cardiac, hepatic, and renal disease
• Alcohol and drug addiction
• Conditions where regional anesthesia is contraindicated
• Failure in the dermatomal examination performed after the block
• Patients with a STOP-BANG score =5

Related Conditions & MeSH terms

• Anesthesia
• Pain, Postoperative
• Postoperative Pain
• Regional Anesthesia

Intervention

Procedure:
• Bilateral ultrasound guided external oblique intercostal block (EOIB)
Bilateral ultrasound-guided EOIB (total of 60 ml, %0.25 bupivacaine) will be performed + IV morphine PCA Multimodal analgesia : Patients are administered iv tenoxicam 20mg and tramadol 100 mg after induction of general anesthesia, and iv paracetamol 1 gr and 0.05 mg/kg, ideal body weight (IBW), iv morphine will be administered. End of the surgery, hyoscine-N-butyl bromide will be administered. Postoperative analgesia: iv paracetamol 1gr every 8 hours and IV PCA of 0,5 mg/ml morphine (the bolus dose is 20 µg/kg, the lock-in time of 6-10 minutes, the 4-hour limit is adjusted to be 80% of the calculated total amount). In cases where rescue analgesia is required (NRS score =4), 50 mg of meperidine is administered to patients. Patients are routinely administered ondansetron 8 mg IV 20 minutes before extubation for postoperative nausea and vomiting prophylaxis.
• Bilateral ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block
Bilateral ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block (total of 60 ml, %0.25 bupivacaine) will be performed + IV morphine PCA Multimodal analgesia : Patients are administered iv tenoxicam 20mg and tramadol 100 mg after induction of general anesthesia, and iv paracetamol 1 gr and 0.05 mg/kg, ideal body weight (IBW), iv morphine will be administered. End of the surgery, hyoscine-N-butyl bromide will be administered. Postoperative analgesia: iv paracetamol 1gr every 8 hours and IV PCA of 0,5 mg/ml morphine (the bolus dose is 20 µg/kg, the lock-in time of 6-10 minutes, the 4-hour limit is adjusted to be 80% of the calculated total amount). In cases where rescue analgesia is required (NRS score =4), 50 mg of meperidine is administered to patients. Patients are routinely administered ondansetron 8 mg IV 20 minutes before extubation for postoperative nausea and vomiting prophylaxis.

Drug:
• IV morphine patient-controlled analgesia (PCA)
Morphine will be administered via PCA device for the first 24 hours after surgery

Locations

Country	Name	City	State
Turkey	Ondokuz Mayis University	Samsun	Atakum

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Erskine RN, White L. "A review of the external oblique intercostal plane block - a novel approach to analgesia for upper abdominal surgery". J Clin Anesth. 2022 Nov;82:110953. doi: 10.1016/j.jclinane.2022.110953. Epub 2022 Aug 19. No abstract available. — View Citation

Gungor H, Ciftci B, Alver S, Golboyu BE, Ozdenkaya Y, Tulgar S. Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) vs local infiltration for pain management after laparoscopic cholecystectomy surgery: a randomized study. J Anesth. 2023 Apr;37(2):254-260. doi: 10.1007/s00540-022-03158-0. Epub 2022 Dec 28. — View Citation

Ibrahim M, Elnabtity AM, Hegab A, Alnujaidi OA, El Sanea O. Combined opioid free and loco-regional anaesthesia enhances the quality of recovery in sleeve gastrectomy done under ERAS protocol: a randomized controlled trial. BMC Anesthesiol. 2022 Jan 21;22(1):29. doi: 10.1186/s12871-021-01561-w. — View Citation

White L, Ji A. External oblique intercostal plane block for upper abdominal surgery: use in obese patients. Br J Anaesth. 2022 May;128(5):e295-e297. doi: 10.1016/j.bja.2022.02.011. Epub 2022 Mar 3. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption in the first 24 hours after surgery	Morphine consumption in the first 24 hours after surgery will be measured. Patients can request opioids via a PCA device when their NRS score is= 4.	Postoperative day 1
Secondary	Postoperative pain scores	Pain status at rest and while activity will be assessed by NRS score at 0, 3, 6, 12, 18, and 24 hours after surgery. The NRS is an 11-point numeric scale that ranges from 0 to 10.	Postoperative day 1
Secondary	Patients' satisfaction and quality of pain management	Patients' pain management satisfaction and quality will be evaluated using the QoR-15 score. The QoR-15 consists of 5 test areas: pain (2 questions), physical comfort (5 questions), physical state (2 questions), psychological state (2 questions), and emotional state (4 questions). Each question is rated on a 10-point scale ranging from 0 = "never" to 10 = "always" (scoring is reversed for negative questions).; QoR-15 Turkish Version will be used for assessment.	Postoperative day 1
Secondary	The incidences of postoperative nausea and vomiting (PONV)	The severity of postoperative nausea and vomiting (PONV) will be assessed using a descriptive verbal rating scale at 0, 3, 6, 12, 18, and 24 hours after extubation. If a score of 3 or more, ondansetron 4 mg IV will be administered and will repeat after 8 hours if required. The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once.	Postoperative day 1
Secondary	Time of first analgesic request	Time at which the first analgesic is requested	Postoperative day 1
Secondary	Intraoperative remifentanil consumption	The total amount of remifentanil consumed will be recorded.	The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 150 minutes.
Secondary	The number of patients with complications	The number of patients has any complications -directly related to the block or the drug used in the block- will be recorded	Postoperative 7 days on an average
Secondary	The number of patients who required rescue analgesia.	he number of patients requiring rescue analgesics will be recorded over 24 hours.	Postoperative day 1