Pain ManagementEarly Phase 1NCT07429916
Ketamine for Shoulder Pain Following Laparoscopic Gastric Sleeve Surgery
A Early Phase 1 study testing Intraoperative ketamine in people with Pain Management and Laparascopic Sleeve Gastrectomy, run by King Abdullah University Hospital at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain Management, Laparascopic Sleeve Gastrectomy
- What is being tested?
- Intraoperative ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jan 2026to 30 Aug 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients aged 18-60
- American society of anesthesiologist grade 1,2
- BMI > 40
- BMI > 35 with obesity-related comorbidities
Who cannot join
- mentally incapacitated
- patients received any type of analgesia 24hr preoperatively except paracetamol
- history of drug abuse
- patients with low ejection fraction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site, 1 recruiting
- Recruiting
King Abdullah University Hospital
Irbid, 22110
Anas Alrusan, +962 7 9701 5888, amalrusan@just.edu.jo
About this study
Official title: The Role of Intraoperative Ketamine Usage as Part of Anesthetic Management in Decreasing the Incidence of Shoulder Pain Following Laparoscopic Gastric Sleeve Surgery
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.
- Conditions
- Pain Management, Laparascopic Sleeve Gastrectomy
- Being tested
- Intraoperative ketamine
- Keywords
- Shoulder pain, ketamine, Postoperative, Gastrectomy
- Medical subject headings
- Agnosia, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative ketamineDrug
intra-operative intravenous ketamine infusion in a dose of 0.3mg/kg/hour
| Study group | Role | What they receive |
|---|---|---|
| Ketamine group | Experimental | Not described Receives: Drug: Intraoperative ketamine |
| no intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Jan 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Principal investigator, anas munir alrusan, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429916
- Sponsor's protocol ID
- Dec2025/189-19
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Intraoperative Ketamine Usage as Part of Anesthetic Management in Decreasing the Incidence of Shoulder Pain Following Laparoscopic Gastric Sleeve Surgery
- ClinicalTrials.gov ID
- NCT07429916
- Acronym / sponsor ID
- Dec2025/189-19
- Conditions
- Pain Management, Laparascopic Sleeve Gastrectomy
- Keywords
- Shoulder pain, ketamine, Postoperative, Gastrectomy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine group | Experimental | Drug: Intraoperative ketamine |
| no intervention | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients aged 18-60
- American society of anesthesiologist grade 1,2
- BMI > 40
- BMI > 35 with obesity-related comorbidities
Key exclusion criteria (4 listed)
- mentally incapacitated
- patients received any type of analgesia 24hr preoperatively except paracetamol
- history of drug abuse
- patients with low ejection fraction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative ketamineintra-operative intravenous ketamine infusion in a dose of 0.3mg/kg/hour | Drug | Ketamine group |
Primary outcome
Postoperative analgesic effect of ketamine using VAS scale
Time frame: 6 months
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.
Postoperative analgesic effect of ketamine using COMFORT scale
Time frame: 6 MONTHS
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intraoperative ketamine in people with Pain Management and Laparascopic Sleeve Gastrectomy, run by King Abdullah University Hospital at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anas Alrusan (+962797015888, amalrusan@just.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative analgesic effect of ketamine using VAS scale (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.