NCT07055438

Brief Summary

The current study is designed to investigate the analgesic potentials of two modalities of abdominal blocks where local anesthetics is injected in the fascial planes of the abdominal muscles to anesthetize the nerves supplying the abdomen in patients undergoing upper abdomial surgeries. the two modalities are the rectus sheath block (RSB) and the external oblique intercostal plane block (EOIPB). The investigators are going to use the ultrasound to identify the muscles and inject the local anesthetics. The investigators suggest that the EOIPB might provide better pain control when compared to RSB.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

June 15, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

July 24, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2025

Completed
Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

June 15, 2025

Last Update Submit

November 30, 2025

Conditions

Keywords

Rectus shealth blockExternal oblique intercostal plane block

Outcome Measures

Primary Outcomes (1)

  • Time to first request for rescue analgesia

    Time from end of surgery to first dose of morphine administered

    Time in hours from end of surgery to first dose of morphine administered up to 24 hours postoperatively

Secondary Outcomes (5)

  • Fentanyl consumption

    From the start of the surgery till the end in micogram/Kg

  • Postoperative morphine consumption

    from the time numerical rating scale exceeds 3 and till 24 hours after the end of the surgery

  • Pain score

    from the time of recovery immediately in the postoperative period and then at 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours postoperatively

  • Patient satisfaction of analgesia

    2 hours after recovery from anesthesia

  • Incidence of postoperative nausea and vomiting

    From the recovery of anesthesia and up to 24 hours postoperatively

Study Arms (2)

RSB

ACTIVE COMPARATOR

Bilateral rectus sheath block for patients undergoing upper abdominal surgeries

Procedure: Ultrasound guided Rectus sheath block

EOIPB

EXPERIMENTAL

Bilateral External oblique intercostal plane block for patients undergoing upper abdominal surgeries

Procedure: ultrasound guided external oblique intercostal plane block

Interventions

After receiving general anesthesia, bilateral ultrasound guided rectus sheath block with 20 ml of 0.25% bupivacaine on each side will be administered to 20 patients undergoing upper abdominal surgeries namely whipple operation and total gastrectomy

RSB

After receiving general anesthesia, bilateral ultrasound guided external oblique intercostal plane block with 20 ml of 0.25% bupivacaine on each side will be administered to 20 patients undergoing upper abdominal surgeries namely whipple operation and total gastrectomy

EOIPB

Eligibility Criteria

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

You may qualify if:

  • Age from 18 to 65 Years
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status II, III.
  • Patients who will undergo upper abdominal surgeries (Whipple operation, total gastrectomy).

You may not qualify if:

  • Coagulation disorders.
  • Abdominal surgery history.
  • Infection in the block application area.
  • Chronic opioid use.
  • Local anesthetic (LA) allergy.
  • Pregnancy.
  • BMI ≥35 kg/m2.
  • Severe cardiovascular problems.
  • Diabetic neuropathy.
  • Complicated surgeries with massive blood loss and hemodynamic instability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kasr El Ainy

Cairo, Egypt

Location

National Cancer institute

Cairo, Egypt

Location

Related Publications (5)

  • 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.

  • Ohgoshi Y, Kawagoe I, Ando A, Ikegami M, Hanai S, Ichimura K. Novel external oblique muscle plane block for blockade of the lateral abdominal wall: a pilot study on volunteers. Can J Anaesth. 2022 Oct;69(10):1203-1210. doi: 10.1007/s12630-022-02310-4. Epub 2022 Aug 23.

  • Abdildin Y, Tapinova K, Salamat A, Shaimakhanov R, Aitbayev A, Viderman D. Rectus Sheath Block in Abdominal Surgery: A Systematic Review with Meta-Analysis. Rom J Anaesth Intensive Care. 2023 Apr 20;30(1):43-50. doi: 10.2478/rjaic-2023-0006. eCollection 2023 Apr.

  • Cho S, Kim YJ, Jeong K, Moon HS. Ultrasound-guided bilateral rectus sheath block reduces early postoperative pain after laparoscopic gynecologic surgery: a randomized study. J Anesth. 2018 Apr;32(2):189-197. doi: 10.1007/s00540-018-2457-0. Epub 2018 Feb 8.

  • Howle R, Ng SC, Wong HY, Onwochei D, Desai N. Comparison of analgesic modalities for patients undergoing midline laparotomy: a systematic review and network meta-analysis. Can J Anaesth. 2022 Jan;69(1):140-176. doi: 10.1007/s12630-021-02128-6. Epub 2021 Nov 5.

Study Officials

  • Mohamed Abd El Fattah, Associate professor

    National Cancer Institute, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Anesthesia, intesive care and pain management - Kasr El Aini Hospital

Study Record Dates

First Submitted

June 15, 2025

First Posted

July 8, 2025

Study Start

July 24, 2025

Primary Completion

November 16, 2025

Study Completion

November 16, 2025

Last Updated

December 2, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

The detailed protocol describing the techniques used in the study and the anesthetic conduct and the outcome measures. The statistical plan to analyze the different outcome measures.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
IPD can be available 2 months after completion of the study
Access Criteria
IPD can be accessed from the authors by journals considering the study for publication and upon reasonable request from other investigators

Locations