Ketamine for Shoulder Pain Following Laparoscopic Gastric Sleeve Surgery

ConditionsPain Management Laparascopic Sleeve Gastrectomy

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18-60

SponsorKing Abdullah University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients aged 18-60

American society of anesthesiologist grade 1,2

BMI > 40

BMI > 35 with obesity-related comorbidities

Disqualifiers

mentally incapacitated

patients received any type of analgesia 24hr preoperatively except paracetamol

history of drug abuse

patients with low ejection fraction

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Ketamine groupExperimental treatment 1 intervention

Group B: no interventionNo intervention 0 interventions

Trial outcomes

Primary outcomes

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

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

Sponsors and contacts

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King Abdullah University Hospital

Lead sponsor

Jordan University of Science and Technology

Sponsor institution

Jordan University of Science and Technology

Collaborator

Source ClinicalTrials.gov

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