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Clinical Trials/NCT07337330
NCT07337330
Not yet recruiting
Not Applicable

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

National Cancer Institute, Egypt1 site in 1 country52 target enrollmentStarted: January 15, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
National Cancer Institute, Egypt
Enrollment
52
Locations
1
Primary Endpoint
Pain scores using Visual analogue score

Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

External Oblique Intercostal (EOI) Plane Block

Active Comparator

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 level, the ultrasound probe is rotated 90° to see the convergence of the internal oblique & transversus abdominus muscles. The probe is then moved back to the initial identification point. The EOI plane is identified deep to the external oblique and superficial to the 6th & 7th ribs and their associated intercostal muscles. Local anaesthetic is injected subcutaneously & a 16 G Tuohy needle is inserted caudally; the EOI plane is hydrodissected with saline, injecting 20 ml of 0.25% bupivacaine.

Intervention: Ultrasound guided external oblique intercostal (EOI) plane block (Procedure)

Erector Spinae (ESP) Block

Active Comparator

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 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 isconsidered confirmatory. Subsequently, 20 mL of local anaesthetic injected 0.25% bupivacaine

Intervention: Ultrasound guided erector spinae block (Procedure)

Outcomes

Primary Outcomes

Pain scores using Visual analogue score

Time Frame: 24 hours after surgery

Pain scores using Visual analogue score (VAS) (0 mm = no pain to 10mm = worst pain imaginable) at predetermined time intervals (1,6, 12 and 24h) postoperative.

Secondary Outcomes

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

Investigators

Sponsor
National Cancer Institute, Egypt
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Asmaa Elsayed Khalil

Lecturer of Anaesthesia, Surgical ICU and Pain Management

National Cancer Institute, Egypt

Study Sites (1)

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