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RecruitingNCT07429916Updated Feb 24, 2026

Ketamine for Shoulder Pain Following Laparoscopic Gastric Sleeve Surgery

An Early Phase 1 interventional study of Intraoperative ketamine in Pain Management and Laparascopic Sleeve Gastrectomy, sponsored by King Abdullah University Hospital. Recruiting at 1 site in Jordan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-02-24.

Sponsored by King Abdullah University Hospital · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Jan 2026; still recruiting 10 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

Obesity is a worldwide problem impairing health and quality of life, therefore , gastric sleeve surgery is considered an efficacious way in managing high body mass index with an excellent outcomes. Patients typically suffer pain following surgery along the incision port sites and in the abdominal cavity, but a significant subset of patients experience shoulder pain, typically in the left shoulder, which is often under-recognized and poorly managed and can be more worrisome to the patient. Shoulder pain following laparoscopy was first noticed by gynecologist in 1976. it is very common as it has an incidence in the range of 34.1%-82.4% . with varying rates among different types of surgery as:57.1%-65.5% after laparoscopic appendectomy, 66% following laparoscopic gastrectomy and 80% after gynecological laparoscopy. The nature of pain is mainly mild to moderate that appears as dull pain lasting 2-3 days but can remain a long time as 5 weeks postoperatively.

The mechanism of post laparoscopic shoulder pain(PLSP) is not fully understood but the most accepted explanation is referred pain via the phrenic nerve, which shares nerve roots with the C3-C5 cervical nerves that innervate the shoulder area The pneumoperitoneum created during laparoscopy causes diaphragmatic irritation, leading to phrenic nerve stimulation and referred pain. Moreover, there were other factors implemented such as malposition intraoperatively, inappropriate shoulder abduction, and early postoperative activity. In addition, the effect of Co2 by itself.

Several management strategies were introduced to combat this phenomena such as: evacuating residual gas(Co2) as active gas aspiration, inserting a drain and pouring saline interperitoneally at end o surgery showed decrement in shoulder pain intensity and frequency. Pulmonary recruitment maneuvers by transiently applying higher positive pressure to the airways and alveoli. Lastly, low pressure pneumoperitoneum which implies 7-10mmgh pressure application reduced the severity and incidence of PLSP.

The hypothesis is that intraoperative ketamine infusion (as part of well-known anesthetic management) will lead to a reduction in the incidence and severity of PLSP. It is known that ketamine is a well-established anesthetic drug for over half a century in clinical practice. In certain doses which is called sub anesthetic doses, ketamine acts as a pain medication. It has the ability to alleviate both acute and chronic pain by just one injection in analgesic dose. A consensus guidelines done in 2018, in managing acute pain by intravenous ketamine resulted that subanesthetic dose have to be considered adjunct in operations which postoperative expected to be withering. The primary aim of the study is to examine the effect of including ketamine in the anesthetic management intraoperatively on the incidence and severity of PLSP compared to standard anesthesia and surgery techniques without it, in addition, outcomes such as duration of recovery, overall hospital stay, post-op analgesic requirements, side effects of ketamine and postoperative nausea and vomiting incidence.

02

Conditions studied

  • Pain Management
  • Laparascopic Sleeve Gastrectomy

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Keywords

  • Shoulder pain
  • ketamine
  • Postoperative
  • Gastrectomy
03

In context

Shoulder Pain

735 studies on the registry are indexed under Shoulder Pain; 167 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 587 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

King Abdullah University Hospital is the lead sponsor of 55 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients aged 18-60
  • grade 1,2
  • > 40
  • BMI > 35 with obesity-related comorbidities

Exclusion criteria

Exclusion Criteria:

  • mentally incapacitated
  • patients received any type of analgesia 24hr preoperatively except paracetamol
  • history of drug abuse
  • patients with low
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Ketamine group

    Drug: Intraoperative ketamine

  • No intervention
    no intervention

Interventions

  • DrugIntraoperative ketamine

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 6 MONTHS

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2026 (actual). Primary completion is estimated for Jun 2026, 5 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 30, 2026
First posted
Feb 24, 2026
StartActual
Jan 1, 2026
Primary completionEst.
Jun 30, 2026
CompletionEst.
Aug 30, 2026
Last update
Feb 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07429916
Lead sponsor
King Abdullah University Hospital
Collaborators
Jordan University of Science and Technology
Responsible party
anas munir alrusan (Assistant Professor of Anesthesia, Jordan University of Science and Technology) — Principal investigator
First posted
Feb 24, 2026
Start date
Jan 1, 2026
Primary completion
Jun 30, 2026 (estimated)
Completion
Aug 30, 2026 (estimated)
Last update
Feb 24, 2026

Study contacts

Anas Alrusan
Contact
amalrusan@just.edu.jo
+962797015888

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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