The Impact of Saline Temperature and Local Anesthetic Adjuvants on Postoperative Shoulder Pain and Inflammatory Marker Levels Following Laparoscopic Cholecystectomy

NCT07450781 | Enrolling By Invitation

• 1 other identifier: Postoperative Shoulder Pain
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic cholecystectomy has become the gold standard for the operative treatment of gallbladder disease due to its minimally invasive nature and improved patient outcomes. However, postoperative pain remains a significant concern following this procedure, affecting patient comfort, recovery, potential for same day discharge and overall satisfaction. However, visceral pain, port-site pain, and referred shoulder pain are occasionally reported in laparoscopic cholecystectomy patients . Postoperative shoulder pain is a common complication following laparoscopic cholecystectomy, often attributed to diaphragmatic irritation.

Conditions

Shoulder Pain , Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Postoperative Shoulder Pain Intensity: VAS scores recorded at 6, 24, 48, and 72 hours postoperatively.

  Postoperative Shoulder Pain Intensity: VAS scores recorded at 6, 24, 48, and 72 hours postoperatively.

  6, 24, 48, and 72 hours postoperatively.

Study Arms (6)

Room-temperature saline without local anesthetic.

EXPERIMENTAL

Other: Room-temperature saline (25-30 ml/kg ) irrigation without local anesthetic.

Room-temperature saline with local anesthetic bupivacaine

EXPERIMENTAL

Other: Room-temperature saline (25-30 ml/kg l) with local anesthetic ( 0.25% bupivacaine according to body weight).

Warm saline irrigation without local anesthetic.

EXPERIMENTAL

Other: Warm saline (37°C, 25-30 ml/kg ) irrigation without local anesthetic.

Warm saline with local anesthetic

EXPERIMENTAL

Other: Warm saline (37°C, 25-30 ml/kg) with local anesthetic (0.25% bupivacaine).

No saline irrigation.

EXPERIMENTAL

Other: No saline irrigation.

No saline irrigation but with local anesthetic

EXPERIMENTAL

Other: No saline irrigation but with local anesthetic (local anesthetic instillation at trocar sites).

Interventions

Room-temperature saline (25-30 ml/kg ) irrigation without local anesthetic. OTHER

Room-temperature saline (25-30 ml/kg ) irrigation without local anesthetic.

Room-temperature saline without local anesthetic.

No saline irrigation. OTHER

No saline irrigation.

No saline irrigation.

Room-temperature saline (25-30 ml/kg l) with local anesthetic ( 0.25% bupivacaine according to body weight). OTHER

Room-temperature saline (25-30 ml/kg l) with local anesthetic ( 0.25% bupivacaine according to body weight).

Room-temperature saline with local anesthetic bupivacaine

Warm saline (37°C, 25-30 ml/kg ) irrigation without local anesthetic. OTHER

Warm saline (37°C, 25-30 ml/kg ) irrigation without local anesthetic.

Warm saline irrigation without local anesthetic.

Warm saline (37°C, 25-30 ml/kg) with local anesthetic (0.25% bupivacaine). OTHER

Warm saline (37°C, 25-30 ml/kg) with local anesthetic (0.25% bupivacaine).

Warm saline with local anesthetic

No saline irrigation but with local anesthetic (local anesthetic instillation at trocar sites). OTHER

No saline irrigation but with local anesthetic (local anesthetic instillation at trocar sites).

No saline irrigation but with local anesthetic

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-65 years.
• Scheduled for elective laparoscopic cholecystectomy
• Informed consent obtained.

You may not qualify if:

• Allergies to anesthetics or saline. 2-Previous shoulder surgery. 3-Significant comorbidities (e.g., chronic pain syndromes, autoimmune diseases). 4-Pregnancy or lactation.
• Current use of anti-inflammatory medications or steroids

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

medical research institute , Alexandrria university

Alexandria, Egypt

Location

Related Publications (1)

• Rosero EB, Joshi GP. Hospital readmission after ambulatory laparoscopic cholecystectomy: incidence and predictors. J Surg Res. 2017 Nov;219:108-115. doi: 10.1016/j.jss.2017.05.071. Epub 2017 Jun 28.

  PMID: 29078868 RESULT

MeSH Terms

Conditions

Shoulder Pain

Interventions

Therapeutic Irrigation; Anesthetics, Local; Bupivacaine

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 17, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months up to one year
• Access Criteria: saline temprature , post operative shoulder pain after lap cholycystectomy

Locations

EG (1)