Ultrasound Guided External Oblique Intercostal Plane Block Versus Erector Spinae Block for Post Hepatectomy Pain

Official title

Comparative Study Between Ultrasound Guided External Oblique Intercostal Plane Block and Erector Spinae Block for Postoperative Analgesia in Hepatectomy Incision in Cancer Patients

Overview

Management of acute post-operative pain has received keen attention in recent years with considerable concurrent advancement in the field. The importance of effective pain relief has long been realised, and acute pain services (APS) are operational in majority of the hospitals in the developed world for decades. Postoperative pain following abdominal surgery if severe enough may cause several side effects as "splinting, hypoventilation, atelectasis, immobility, hypercoagulability, thromboembolic events, vasoconstriction, tachycardia, increased systemic vascular resistance, dysrhythmias and cardiac ischemia in susceptible patients, insomnia, anxiety, feeling of helplessness". Ultrasound-guided fascial plane blocks have been rapidly incorporated into regional anaesthesia practice in recent years as an alternative to neuraxial techniques and involve injection into a tissue plane to provide analgesia in various anatomic areas. External oblique intercostal plane block (EOIPB) is a novel block, which has been described as an important modification of the fascial plane blocks that can consistently involve the upper lateral abdominal walls. The erector spinae plane (ESP) block is a new regional aesthetic technique that can be used to provide analgesia for a variety of surgical procedures or to manage acute or chronic pain. The technique is relatively easy to perform on patients. The ESPB involves injection of local anaesthetic in the erector spinae fascial plane, superficial to the tip of the transverse process of the vertebra and deep to the erector spinae muscle.

Detailed description

A 20G IV cannula will be inserted. All patients will be premedicated with IV midazolam 0.01-0.02 mg/kg 30 minutes preoperatively. all patients will be monitored continuously using ECG, NIBP, peripheral arterial oxygen saturation and end tidal carbon dioxide throughout the duration of surgery.

Induction of general anaesthesia will be done by propofol 1.5-2 mg/kg, fentanyl 1-2 μg/kg, and atracurium 0.5 mg/kg IV. All patients will receive paracetamol 1 gm by IV drip, ketorolac 30 mg IV drip. Anaesthesia will be maintained by sevoflurane 2%-3% in O2/air mixture with reinjection of atracurium 0.1 mg/kg every 30 minutes. The same procedures will be applied to all patients.

Group 1 - External Oblique Intercostal Block (EOI) Patients positioned in the supine position with their ipsilateral arm abducted. A 12-15 MHz linear transducer (FUJIFILM Sonosite M-Turbo C Ultrasound System) will be used for ultrasonography. With the proceduralist at the patient's ipsilateral shoulder, the chest wall is systematically scanned. Initially the probe is placed in a cephalad to caudad paramedian direction at the anterior axillary line, and the external oblique muscle identified at the level ribs 6 and 7 in line with the xiphoid process. To confirm correct identification of the external oblique muscle, the probe is moved in the caudad direction following the external oblique muscle. At the subcostal level, the ultrasound probe is rotated 90° to see the convergence with the internal oblique and transversus abdominus muscles. The probe is then moved back to the initial identification point for the external oblique muscle. The EOI plane is identified deep to the external oblique muscle and superficial to the sixth and seventh ribs and their associated intercostal muscles. Local anaesthetic is then infiltrated subcutaneously and a 16 G Tuohy needle is inserted cephalad to caudad, and the EOI plane was hydro-dissected with saline,20 ml of local anaesthetic injected (0.25% bupivacaine)(8).

Group 2 - Erector Spinae Block (ESP) The patient in lateral position, then spinous processes were palpated and marked directly on the skin by a dermographic pencil, and the correctness of the final marking was confirmed by sonographic inspection. A 21-gauge, 50 mm needle was inserted with a cephalad-to-caudal direction into the posterior thoracic wall at the T5 level, to reach the respective transverse process.

The proper needle tip positioning was checked by ultrasound guidance with a 12.5 MHz linear probe (FUJIFILM Sonosite M-Turbo C Ultrasound System) the visualization of a linear fluid spread that distended the fascial plane between the erector spinae muscles group and the transverse process while injecting 2 mL of normal saline solution was considered confirmatory.

Subsequently, 20 mL of local anaesthetic injected 0.25% bupivacaine (9).

Intraoperative rescue analgesia of fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels. Ringer acetate will be infused to replace the fluid deficit, maintenance and losses, and the patients will be mechanically ventilated at appropriate settings that keep end-tidal CO2 at 30- 35 mmHg.

The 1st reading of mean arterial pressure (MAP) and heart rate (HR) will be recorded before induction of general anaesthesia to be defined as a baseline reading while another reading will be noted immediately before surgical incision and at 15-minute intervals intraoperatively.

At the end of surgery residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and extubation will be performed after complete recovery of the airway reflexes.

The patients will be transferred to the post-anaesthesia care unit (PACU) where the Visual Analogue Scale score (VAS), MAP and heart rate will be noted immediately on arrival, and the patients will be observed till fulfilling the criteria of discharge then transferred to the ward where multimodal analgesia will be provided as the following: IV paracetamol 1 g /8 hours and IV ketorolac 30mg/8 hours.

Post-operative rescue analgesia will be provided in the form of IV morphine 0.1 mg per kg if the patient VAS Score ≥ 4. The total amount of morphine given in 24 hours will be recorded for both groups. A maximum dose of 0.5 mg/kg/24hours of morphine is allowed. VAS, MAP, and heart rate will be noted at 1, 6, 12, and 24 hours postoperatively. Side effects of morphine include: nausea, vomiting, sedation, and respiratory depression (respiratory rate \<10/minute), and they will be recorded.

Postoperative nausea and vomiting (PONV) will be rated on a four-point verbal scale; (none =no nausea, mild =nausea but no vomiting, moderate=vomiting one attack, severe =vomiting \>one attack). 0.1 mg/kg of IV ondansetron will be given to patients with moderate or severe postoperative nausea and vomiting.

Interventions

• Procedure Ultrasound guided external oblique intercostal (EOI) plane block
  Patient lies supine with their ipsilateral arm abducted. A 12-15 MHz linear transducer will be used. The proceduralist scans the chest wall while at the patient's ipsilateral shoulder. The probe is placed in a cephalad to caudad paramedian direction at the anterior axillary line, and the external oblique muscle (EOM) is identified at the level of ribs 6 \&7 in line with the xiphoid process. To confirm identification of the EOM, the probe is moved caudally following the EOM. At the subcostal leve
• Procedure Ultrasound guided erector spinae block
  The patient lies in lateral position, then spinous processes are palpated and marked directly on the skin by a dermographic pencil, and the correctness of the final marking is confirmed by sonographic inspection. A 21G, 50 mm needle isinserted with a cephalad-to-caudal direction into the posterior thoracic wall at the T5 level, to reach the respective transverse process. The proper needle tip positioning ischecked by ultrasound guidance with a 12.5 MHz linear probe (FUJIFILM Sonosite M-Turbo C U

Primary outcome measures

• Pain scores using Visual analogue score [Time frame: 24 hours after surgery]

Secondary outcome measures (6)

• Time of first rescue postoperative analgesia [Time frame: First 24 hours post-operative]
• Total amount of fentanyl consumed intraoperative [Time frame: Duration of the surgery]
• Total amount of morphine consumed postoperatively [Time frame: First 24 hours post-operative]
• Post-operative morphine side effects in the post-operative period. [Time frame: First 24 hours post-operative]
• Changes and stability in Mean Arterial Blood Pressure (MAP) [Time frame: every 15 minutes during the surgery then at 1, 6, 12 and 24 hours postoperatively]
• Changes and stability in Heart Rate (HR) [Time frame: every 15 minutes during the surgery then at 1, 6, 12 and 24 hours postoperatively]

Eligibility criteria

Inclusion criteria

• Cancer patients undergoing hepatectomy under general anaesthesia
• Aged 18 years or older
• ASA II \& III
• BMI >20kg/m2 and <35kg/m2

Exclusion criteria

• History of psychiatric disorders or history of major depression.
• Major medical conditions (heart failure , chronic kidney disease ,patient on dialysis)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Egypt · 1 center

• National Cancer Institute - Cairo University — Cairo

Publications

• Saad SI, Abd El-Hamid AM, Elbarbary DH, Taher MG. Analgesic Efficacy of Ultrasound-Guided Erector Spinae Plane Block versus Transversus Abdominis Plane Block for Post-Operative Pain Relief in Patients Scheduled for Abdominal Surgeries. Benha medical journal, 2023; 40: 32-48
• Bonvicini D, Boscolo-Berto R, De Cassai A, Negrello M, Macchi V, Tiberio I, Boscolo A, De Caro R, Porzionato A. Anatomical basis of erector spinae plane block: a dissection and histotopographic pilot study. J Anesth. 2021 Feb;35(1):102-111. doi: 10.1007/s00540-020-02881-w. Epub 2020 Dec 19. PMID 33340344
• 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. PMID 35249704
• Chin KJ, El-Boghdadly K. Mechanisms of action of the erector spinae plane (ESP) block: a narrative review. Can J Anaesth. 2021 Mar;68(3):387-408. doi: 10.1007/s12630-020-01875-2. Epub 2021 Jan 6. PMID 33403545
• Elsharkawy H, Kolli S, Soliman LM, Seif J, Drake RL, Mariano ER, El-Boghdadly K. The External Oblique Intercostal Block: Anatomic Evaluation and Case Series. Pain Med. 2021 Nov 26;22(11):2436-2442. doi: 10.1093/pm/pnab296. PMID 34626112
• Clarke HA, Manoo V, Pearsall EA, Goel A, Feinberg A, Weinrib A, Chiu JC, Shah B, Ladak SSJ, Ward S, Srikandarajah S, Brar SS, McLeod RS. Consensus Statement for the Prescription of Pain Medication at Discharge after Elective Adult Surgery. Can J Pain. 2020 Mar 8;4(1):67-85. doi: 10.1080/24740527.2020.1724775. PMID 33987487
• Jindal S, Sidhu GK, Baryha GK, Singh B, Kumari S, Mahajan R. Comparison of efficacy of thoracic paravertebral block with oblique subcostal transversus abdominis plane block in open cholecystectomy. J Anaesthesiol Clin Pharmacol. 2020 Jul-Sep;36(3):371-376. doi: 10.4103/joacp.JOACP_148_19. Epub 2020 Sep 26. PMID 33487905
• Afshan G, Khan RI, Ahmed A, Siddiqui AS, Rehman A, Raza SA, Kerai R, Mustafa K. Post-operative pain management modalities employed in clinical trials for adult patients in LMIC; a systematic review. BMC Anesthesiol. 2021 May 25;21(1):160. doi: 10.1186/s12871-021-01375-w. PMID 34034672

Identifiers

NCT: NCT07337330 · AP2509-501-126-203

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗