Ropivacaine Use Intraincisionally Versus Intraperitoneally for Post-Laparoscopic Cholecystectomy Pain

NCT03265223 | Completed Phase 4 DMC

• 1 other identifier: JawaharlalNMC
• Study Type: interventional
• Target: 353
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pain still remains a limiting factor in early discharge of patients undergoing laparoscopic cholecystectomy. Almost all earlier studies done to compare the efficacy of local anaesthetics used intraperitoneally as compared to intraincisionally used equal amounts of drugs at the two locations, usually 10-20 ml. Using this large amount of drug in the small space of intraincisional location as compared to similar amount of drug in large intraperitoneal space created an inadvertent bias in favor of patients receiving the drug intraincisionally so such patients naturally experienced less pain. The investigators decided to standardize the drug used at these two locations as 1ml/cm and conduct a new study comparing the effects of drugs in relieving pain when used at these two locations.

Conditions

Ropivacaine; Laparoscopic Cholecystectomy; Pain

Keywords

Ropivacaine; local anesthesia; intraincisional infiltration; intraperitoneal instillation; post-laparoscopic cholecystectomy pain; shoulder pain; rescue analgesia; triple blinding

Outcome Measures

Primary Outcomes (1)

• Effect of ropivacaine use intraincisionally versus intraperitoneally as compared to controls on post-laparoscopic cholecystectomy pain

  To study and assess the effect and impact of using the local anesthetic ropivacaine 0.2%, over controls, on the intensity of postoperative pain in patients undergoing laparoscopic cholecystectomy; and to compare and assess the optimal site i.e. intraincisional versus intraperitoneal of using local anesthetic (ropivacaine) for better post-laparoscopic cholecystectomy pain relief.

  36 months

Secondary Outcomes (3)

• Identify the component of pain which is dominant after undergoing laparoscopic cholecystectomy

  36 months

• Laparoscopic cholecystectomy as day-case using ropivacaine only

  36 months

• Changing trends in epidemiology of cholelithiasis

  36 months

Study Arms (3)

Controls

NO INTERVENTION

Received 1 ml/cm normal saline (23 ml) both at intraperitoneal (=20 ml) as well as intraincisional (=3 ml) location.

Intraperitoneal group

ACTIVE COMPARATOR

Received 20 ml of 0.2% ropivacaine intraperitoneally (1 ml/cm; 16 ml along right hemi-dome, approximately equal to length of right hemi-dome of diaphragm in an average adult and 4 ml in gall bladder fossa) and 3 ml normal saline (1ml/cm of port site incision length)

Drug: 0.2% ropivacaine

Intraincisional group

ACTIVE COMPARATOR

Received 20 ml of normal saline intraperitoneally (1 ml/cm; 16 ml along right hemi-dome, approximately equal to length of right hemi-dome of diaphragm in an average adult and 4 ml in gall bladder fossa) and 3 ml 0.2% ropivacaine (1ml/cm of port site incision length)

Drug: 0.2% ropivacaine

Interventions

0.2% ropivacaine DRUG

Intraperitoneal instillation versus intraincisional infiltration

Also known as: Ropin, Naropin

Intraincisional group; Intraperitoneal group

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients in the age group of 15-80 years
• Patients conferring to Grade I or II of American Society of Anesthesiologists (ASA) physical status classification system only
• Patients undergoing elective Laparoscopic Cholecystectomy
• Patients having symptomatic cholelithiasis only
• Patients operated by a single surgeon were included.

You may not qualify if:

• Patients with known allergic reactions to local anesthetics
• Cases that were converted to open cholecystectomy
• Patients with major intra-operative complications
• Patients suffering from acute cholecystitis, empyema or malignancy of gall bladder, having history of chronic pain or those taking frequent analgesics or opioids pre-operatively
• Patients with peptic ulceration, bleeding disorders, impaired renal and/or hepatic function, and sensitivity to NSAIDs or opioids.
• Patients in whom gall bladder (GB) stones are found incidentally on ultrasonography (USG) (asymptomatic cholelithiasis)
• Patients suffering from severe chronic medical diseases and morbid obesity
• Patients unable to comprehend instructions or having communication problems were excluded from the study.

Sponsors & Collaborators

• Jawaharlal Nehru Medical College: lead

MeSH Terms

Conditions

Pain; Shoulder Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Kaushal D Singh, MS Surgery

  Jawaharlal Nehru Medical College, Aligarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Triple blinding was done i.e. neither the operating surgeon nor the investigator and nor the patient knew to which study group patient belong to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three study groups: Controls received no drug, intraperitoneal group received drug along right hemidiaphragm and in gallbladder fossa while intraincisional group received drug by infiltration at trocar site

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 29, 2017
• Study Start: April 1, 2014
• Primary Completion: March 31, 2017
• Study Completion: August 15, 2017
• Last Updated: August 30, 2017

Record last verified: 2017-08