NCT07370181

Brief Summary

Patients will be assigned randomly to two groups (30 subjects each) to be anesthetized. The study drug will be delivered in opaque bags labeled "study drug" and 60 patients will be allocated in two groups (of 30 patients each) to receive the irrigation at the end of surgery after dissection; irrigation analgesia by 5 ml bupivacaine 0.50% plus 20 ml normal saline (Group N) or 5 ml bupivacaine 0.50% plus 1 mg/kg ketamine (Group K). The volume of irrigation in group K is completed by normal saline to reach a total of 25 ml.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3 pain

Timeline
2mo left

Started Jan 2026

Shorter than P25 for phase_3 pain

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 Progress61%
Jan 2026Jul 2026

First Submitted

Initial submission to the registry

January 19, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2026

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

January 19, 2026

Last Update Submit

January 19, 2026

Conditions

Pain

Keywords

ketaminePostoperative painLaparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • The total consumption of rescue analgesics

    The total consumption of postoperative rescue analgesics was recorded from the time to first request rescue analgesia to patient discharge after 24 h.

    24 hours

Secondary Outcomes (2)

  • The VAS pain score

    24 hours

  • the time to first request for rescue analgesics

    24 hours

Study Arms (2)

Group N

PLACEBO COMPARATOR

Patients will receive the irrigation at the end of surgery after dissection; irrigation analgesia by 5 ml bupivacaine 0.50% plus 20 ml normal saline (Group N)

Drug: Normal saline

Group K

EXPERIMENTAL

Patients will receive 5 ml bupivacaine 0.50% plus 1 mg/kg ketamine (Group K). The volume of irrigation in group K is completed by normal saline to reach a total of 25 ml.

Drug: Ketamine

Interventions

Normal salineDRUG

Patients will receive the irrigation at the end of surgery after dissection; irrigation analgesia by 5 ml bupivacaine 0.50% plus 20 ml normal saline (Group N)

Group N
KetamineDRUG

Patients will receive 5 ml bupivacaine 0.50% plus 1 mg/kg ketamine (Group K). The volume of irrigation in group K is completed by normal saline to reach a total of 25 ml.

Also known as: Katlar
Group K

Eligibility Criteria

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

You may qualify if:

  • Patients with age ≥18 years of ASA I-II who will be scheduled for elective laparoscopic cholecystectomy under general anesthesia.

You may not qualify if:

  • History of congenital heart disease
  • Hypertension
  • Developmental delay, or
  • Allergy to study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Saadati K, Razavi MR, Nazemi Salman D, Izadi S. Postoperative pain relief after laparoscopic cholecystectomy: intraperitoneal sodium bicarbonate versus normal saline. Gastroenterol Hepatol Bed Bench. 2016 Summer;9(3):189-96. PMID: 27458511; PMCID: PMC4947133.

    RESULT

MeSH Terms

Conditions

PainPain, Postoperative

Interventions

Saline SolutionKetamine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Omar Makram Soliman, MD

    Assiut University, Faculty of Medicine, Anesthesia, surgical ICU and pain management Department

    STUDY DIRECTOR

Central Study Contacts

Omar Makram Soliman, MD

CONTACT

00201065491191omar@aun.edu.eg

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 19, 2026

First Posted

January 27, 2026

Study Start

January 30, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 10, 2026

Last Updated

January 27, 2026

Record last verified: 2026-01