NCT07429916

Brief Summary

Shoulder pain is a well-recognized complaint following laparoscopic surgery. It is underlying mechanism has various causes, therefore, modalities in management and prevention of this sort of pain are numerous with different success rates. In the light of this, the investigators aim to compare an anesthetic management plan involving using ketamine (which is a known intraoperative anesthetic agent) to another not involving it for participants undergoing gastric sleeve, and compare the incidence and intensity of shoulder pain afterwards.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
4mo left

Started Jan 2026

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress53%
Jan 2026Aug 2026

Study Start

First participant enrolled

January 1, 2026

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

January 30, 2026

Last Update Submit

February 22, 2026

Conditions

Keywords

Shoulder painketaminePostoperativeGastrectomy

Outcome Measures

Primary Outcomes (2)

  • Postoperative analgesic effect of ketamine using VAS scale

    The significance of this research is to assess the role of involving ketamine in the anesthetic plan intraoperatively in reducing postoperative shoulder pain in patients undergoing laparoscopic gastric sleeve. The visual analog scale (VAS) is a pain rating scale. Scores are based on self-reported measures of symptoms that are recorded were 0 there is no pain, and 10 is the worst pain.

    6 months

  • Postoperative analgesic effect of ketamine using COMFORT scale

    The Comfort scale is a behavioural method of measuring distress and pain. This scale has eight indicators: alertness, calmness / agitation, respiratory response, physical movement, blood pressure, heart rate, muscle tone, facial tension. Each indicator is scored between 1 and 5 based. Participants would be observed during the postoperative course. The total score can range between 8 to 40. A score of 17 to 26 generally indicates adequate sedation and pain control.

    6 MONTHS

Study Arms (2)

Ketamine group

EXPERIMENTAL
Drug: Intraoperative ketamine

no intervention

NO INTERVENTION

Interventions

intra-operative intravenous ketamine infusion in a dose of 0.3mg/kg/hour

Ketamine group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients aged 18-60
  • American society of anesthesiologist grade 1,2
  • BMI \> 40
  • BMI \> 35 with obesity-related comorbidities

You may not qualify if:

  • mentally incapacitated
  • patients received any type of analgesia 24hr preoperatively except paracetamol
  • history of drug abuse
  • patients with low ejection fraction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdullah University Hospital

Irbid, 22110, Jordan

RECRUITING

MeSH Terms

Conditions

AgnosiaShoulder Pain

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsArthralgiaJoint DiseasesMusculoskeletal DiseasesPain

Central Study Contacts

Study Design

Study Type
interventional
Phase
early phase 1
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
Assistant Professor of Anesthesia

Study Record Dates

First Submitted

January 30, 2026

First Posted

February 24, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations