NCT06007378

Brief Summary

Erector spinae plane block (ESPB) is a novel regional block technique that was proven to have superior outcomes in relieving postoperative pain in colorectal surgeries.Ketamine enhances the impact of local anaesthetics by reducing the duration and extent of motor block while shortening the onset of sensory and motor block.Transdermal Fentanyl Patch (TFP) was better than transdermal buprenorphine in postoperative analgesia following abdominal surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

September 5, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2025

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

August 17, 2023

Last Update Submit

February 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • The time to first rescue analgesia after surgery (hour)

    The time to first rescue analgesia after surgery (hour)

    The first 48 hours after surgery

Study Arms (3)

Bupivacaine and ketamine

OTHER
Other: Bupivacaine and ketamine

Bupivacaine and transdermal fentanyl patch

OTHER
Other: Bupivacaine and transdermal fentanyl patch

Bupivacaine

OTHER
Other: Bupivacain

Interventions

Bilateral erector spinae plane block (bupivacaine and ketamine)

Bupivacaine and ketamine

Bilateral erector spinae plane block (bupivacaine) and transdermal fentanyl patch

Bupivacaine and transdermal fentanyl patch

Bilateral erector spinae plane block (bupivacaine)

Bupivacaine

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing laparoscopic colorectal surgery.
  • American Society of Anesthesiologists (ASA) physical status I or II.

You may not qualify if:

  • Known allergy to one of the study medications.
  • Skin infections at the site of the needle puncture.
  • Hepatic, renal or cardiac dysfunction.
  • Patients diagnosed with obstructive sleep apnoea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain-Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

BupivacaineKetamine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesia and Intensive Care, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 23, 2023

Study Start

September 5, 2023

Primary Completion

July 22, 2025

Study Completion

July 22, 2025

Last Updated

February 18, 2026

Record last verified: 2026-02

Locations