Ketamine for Shoulder Pain Following Laparoscopic Gastric Sleeve Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Pain Management; Laparascopic Sleeve Gastrectomy
• Intervention / Treatment: Drug: Intraoperative ketamine

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Anas Alrusan; Phone Number: +962797015888; Email: amalrusan@just.edu.jo

Study Locations

• Jordan
  • Irbid, Jordan, 22110
    • Recruiting
    • King Abdullah University Hospital
    • Contact: Anas Alrusan; Phone Number: +962 7 9701 5888; Email: amalrusan@just.edu.jo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: no intervention
Experimental: Ketamine group	Drug: Intraoperative ketamine; intra-operative intravenous ketamine infusion in a dose of 0.3mg/kg/hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: King Abdullah University Hospital
• Collaborators: Jordan University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: January 30, 2026
• First Submitted That Met QC Criteria: February 22, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: ketamine; Postoperative; Gastrectomy; Shoulder pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Joint Diseases; Neurobehavioral Manifestations; Arthralgia; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Shoulder Pain; Agnosia
• Other Study ID Numbers: Dec2025/189-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No