Ropivacaine Use Intraincisionally Versus Intraperitoneally for Post-Laparoscopic Cholecystectomy Pain

NCT ID: NCT03265223

Last Updated: 2017-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 353 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-01
• Study Completion Date: 2017-08-15

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.

Detailed Description

Aims & Objectives: To conduct a randomized, triple-blind, placebo-controlled study by standardizing dose of local anesthetic, to compare the effectiveness of intraperitoneal against intraincisional use of ropivacaine 0.2% for post-laparoscopic cholecystectomy pain relief.

Materials & Methods: American Society of Anesthesiologists (ASA) physical status I or II patients underwent elective 4 port laparoscopic cholecystectomy by a single surgeon. Anesthetic and surgical techniques were standardized. Patients were randomized using envelope method into 3 groups according to location of drug use. Triple blinding was ensured and envelopes were opened only at the completion of study. All patients received ~23 ml of solution, of which 20 ml was given 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 intraincisionally (1 ml/cm of length of incision). Controls (n=86) received ~23 ml normal saline (20 ml intraperitoneally and 1 ml/cm intraincisionally) while the intraperitoneal group (n=100) received 20 ml of intraperitoneal instillation of injection ropivacaine 0.2% and 1 ml/cm of normal saline intraincisionally at the end of procedure. Intraincisional group (n=108) received 20 ml normal saline intraperitoneally and 1 ml/cm of injection ropivacaine 0.2% infiltration at incisional site at the end of procedure. All patients received injection diclofenac sodium 75mg/1ml (aqueous) intravenously 12 hourly postoperatively. 5 different pain scales were used for assessment of overall pain. Pain scores were assessed at 5 points of time, that is, at 0.5, 4, 8, 12 and 24 hours postoperatively. Shoulder pain and extra dose of analgesic required (rescue analgesia) were also recorded.

Conditions

Ropivacaine; Laparoscopic Cholecystectomy; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intraincisional group

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)

Group Type: ACTIVE_COMPARATOR

0.2% ropivacaine

Intervention Type: DRUG

Intraperitoneal instillation versus intraincisional infiltration

Controls

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intraperitoneal group

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)

Group Type: ACTIVE_COMPARATOR

0.2% ropivacaine

Intervention Type: DRUG

Intraperitoneal instillation versus intraincisional infiltration

Interventions

0.2% ropivacaine

Intraperitoneal instillation versus intraincisional infiltration

Intervention Type: DRUG

Other Intervention Names

Ropin; Naropin

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jawaharlal Nehru Medical College

OTHER

Sponsor Role: lead

Responsible Party

Kaushal Deep Singh

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kaushal D Singh, MS Surgery

Role: PRINCIPAL_INVESTIGATOR

Jawaharlal Nehru Medical College, Aligarh

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

JawaharlalNMC

Identifier Type: -

Identifier Source: org_study_id