Comparing Efficacy of Different Drugs Combinations for Serratus Anterior Block for Thoracotomy

NCT05565235 | Unknown Phase 4

• 1 other identifier: N-50-2022
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

We aim to compare efficacy and efficiency of serratus anterior block with bupivacaine alone to bupivacaine/magnesium and bupivacaine /nalbuphine in postoperative analgesia for thoracotomy surgery. Objectives: To compare bupivacaine alone, bupivacaine/magnesium and bupivacaine /nalbuphine in serratus anterior plane block for intraoperative and postoperative analgesia for thoracotomy surgery.

• The time for 1st rescue analgesia.
• Calculation of the opioid requirements; (the total intra-operative post-operative morphine consumption in first 24h postoperative).
• Assessment of pain score (VAS)- rest, VAS-movement, VAS-cough during post-operative 24hrs period. Hypothesis: We hypothesize that magnesium sulfate and nalbuphine can reduce acute postoperative pain and result in efficacious postoperative analgesia due to block of the lateral cutaneous branches of the intercostal nerves (T2 - T6) by diffusion across the inter-fascial planes.

Conditions

Post Operative Pain, Acute

Keywords

thoracotomy; serratus anterior plane block

Outcome Measures

Primary Outcomes (1)

• The time of 1st rescue analgesia post operative

  if VAS or VAS-movement \>3.

  one year

Secondary Outcomes (4)

• Pain assessment score; (VAS score) VAS-movement and VAS-cough

  one year

• Total amount of morphine (mg) used in 24h post operatively

  one year

• Hemodynamic changes (SBP, DB, MAP)

  one year

• Incidence of local anesthetic toxicity.

  one year

Study Arms (3)

Group B

ACTIVE COMPARATOR

bupivacaine

Drug: patients will receive intraoperative serratus block with bupivacaine

Group BMG

ACTIVE COMPARATOR

bupivacaine/ magnesium.

Drug: serratus block with bupivacaine /magnesium

Group BN

ACTIVE COMPARATOR

bupivacaine /nalbuphine.

Drug: serratus block with bupivacaine with nalbuphine

Interventions

patients will receive intraoperative serratus block with bupivacaine DRUG

no additives

Group B

serratus block with bupivacaine /magnesium DRUG

magnesium added

Group BMG

serratus block with bupivacaine with nalbuphine DRUG

nalbuphine added

Group BN

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective thoracotomy or unplanned thoracotomy after failed thoracoscopic surgery
• Patient with American Society of Anesthesiology ASA I, II or III.

You may not qualify if:

• Patient refusal
• Contraindication for regional anesthesia
• Allergy from local anesthetics
• Bleeding diathesis (Bleeding tendency with prothrombin concentration PC less than 75 % or platelet count less than 50,000/µL.
• Use of anticoagulants, infection at the puncture site.
• Presence of severe Chronic renal impairment or acute renal failure, decompensated liver disease, cardiac or psychiatric disorders, GIT ulcers, communication barriers, hearing deficit or high grades of visual deficit that interfere with consenting, VAS assessments, and delirium, or another cognitive dysfunction.
• Patient intubated preoperatively.
• Patient will not be extubated immediately postoperatively
• Opioid tolerant patients.
• Any contraindications of Magnesium infusion as hypovolemia or severe impaired ventricular systolic function.
• Contraindication of acetaminophen and Diclofenac sodium administration.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy

Cairo, 11562, Egypt

RECRUITING

Related Publications (7)

• Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.

  PMID: 18456219 BACKGROUND

• Kavanagh BP, Katz J, Sandler AN. Pain control after thoracic surgery. A review of current techniques. Anesthesiology. 1994 Sep;81(3):737-59. doi: 10.1097/00000542-199409000-00028. No abstract available.

  PMID: 8092520 BACKGROUND

• Katz J, Jackson M, Kavanagh BP, Sandler AN. Acute pain after thoracic surgery predicts long-term post-thoracotomy pain. Clin J Pain. 1996 Mar;12(1):50-5. doi: 10.1097/00002508-199603000-00009.

  PMID: 8722735 BACKGROUND

• Kaushal B, Chauhan S, Saini K, Bhoi D, Bisoi AK, Sangdup T, Khan MA. Comparison of the Efficacy of Ultrasound-Guided Serratus Anterior Plane Block, Pectoral Nerves II Block, and Intercostal Nerve Block for the Management of Postoperative Thoracotomy Pain After Pediatric Cardiac Surgery. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):418-425. doi: 10.1053/j.jvca.2018.08.209. Epub 2018 Aug 31.

  PMID: 30293833 BACKGROUND

• Semyonov M, Fedorina E, Grinshpun J, Dubilet M, Refaely Y, Ruderman L, Koyfman L, Friger M, Zlotnik A, Klein M, Brotfain E. Ultrasound-guided serratus anterior plane block for analgesia after thoracic surgery. J Pain Res. 2019 Mar 11;12:953-960. doi: 10.2147/JPR.S191263. eCollection 2019.

  PMID: 30881105 BACKGROUND

• De Oliveira GS Jr, Castro-Alves LJ, Khan JH, McCarthy RJ. Perioperative systemic magnesium to minimize postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2013 Jul;119(1):178-90. doi: 10.1097/ALN.0b013e318297630d.

  PMID: 23669270 BACKGROUND

• Chawda PM, Pareek MK, Mehta KD. Effect of nalbuphine on haemodynamic response to orotracheal intubation. J Anaesthesiol Clin Pharmacol. 2010 Oct;26(4):458-60.

  PMID: 21547169 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Magnesium; Nalbuphine

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; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Tamer M. Atteya, M.D

  Lecturer of anesthesia,surgical ICU and pain managment

  STUDY CHAIR

Central Study Contacts

Ahmed H. Sayed, M.D

CONTACT

+201068112464; drahmedhusseinanesth87@gmail.com

Tamer M. Atteya, M.D

CONTACT

+201223444664; tameratteya_1980@live.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: patient doesn't know which type of drugs given to him in the block , and the investigator who collect postoperative data also doesn't know which type of drugs used in the block
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia , surgical ICU and pin managment

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 4, 2022
• Study Start: December 9, 2022
• Primary Completion: September 10, 2023
• Study Completion: November 10, 2023
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)