NCT07337330

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Jan 2026Sep 2026

First Submitted

Initial submission to the registry

January 1, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 1, 2026

Last Update Submit

January 29, 2026

Conditions

Keywords

hepatectomyerector spinae blockexternal oblique intercostal plane blockliver cancerultrasound guided

Outcome Measures

Primary Outcomes (1)

  • Pain scores using Visual analogue score

    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.

    24 hours after surgery

Secondary Outcomes (6)

  • Time of first rescue postoperative analgesia

    First 24 hours post-operative

  • Total amount of fentanyl consumed intraoperative

    Duration of the surgery

  • Total amount of morphine consumed postoperatively

    First 24 hours post-operative

  • Post-operative morphine side effects in the post-operative period.

    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

  • +1 more secondary outcomes

Study Arms (2)

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.

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

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

Procedure: Ultrasound guided erector spinae block

Interventions

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.

External Oblique Intercostal (EOI) Plane 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 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

Erector Spinae (ESP) Block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute - Cairo University

Cairo, 11796, Egypt

Location

Related Publications (10)

  • 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

    BACKGROUND
  • 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: 33340344BACKGROUND
  • 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: 35249704BACKGROUND
  • 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: 33403545BACKGROUND
  • 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: 34626112BACKGROUND
  • 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: 33987487BACKGROUND
  • 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: 33487905BACKGROUND
  • 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: 34034672BACKGROUND
  • Dengler KL, Brooks DI, Gruber DD. Multimodal approach to postoperative pain is clinically important. Am J Obstet Gynecol. 2022 Aug;227(2):369. doi: 10.1016/j.ajog.2022.05.004. Epub 2022 May 11. No abstract available.

    PMID: 35562050BACKGROUND
  • Linzbach A, Nitschke D, Rothaug J, Komann M, Weinmann C, Schleussner E, Meissner W, Jimenez Cruz J, Schneider U. Peripartal pain perception and pain therapy: introduction and validation of a questionnaire as a quality instrument. Arch Gynecol Obstet. 2022 Jun;305(6):1409-1419. doi: 10.1007/s00404-021-06246-w. Epub 2021 Sep 20.

    PMID: 34542680BACKGROUND

MeSH Terms

Conditions

Cancer PainLiver Neoplasms

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Officials

  • Mohamed Mohamed, MD

    National Cancer Institute Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Mohamed, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anaesthesia, Surgical ICU and Pain Management

Study Record Dates

First Submitted

January 1, 2026

First Posted

January 13, 2026

Study Start

January 15, 2026

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

September 15, 2026

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations