Pain Clinical Trial
Official title:
Randomized Controlled Study of Intraincisional Infiltration Versus Intraperitoneal Instillation of Standardized Dose of Ropivacaine 0.2% in Post-laparoscopic Cholecystectomy Pain
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
Completed |
NCT04748367 -
Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care
|
N/A | |
Terminated |
NCT04356352 -
Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain
|
Phase 2/Phase 3 | |
Completed |
NCT05057988 -
Virtual Empowered Relief for Chronic Pain
|
N/A | |
Completed |
NCT04466111 -
Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
|
||
Recruiting |
NCT06206252 -
Can Medical Cannabis Affect Opioid Use?
|
||
Completed |
NCT05868122 -
A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
|
Phase 3 | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Completed |
NCT03273114 -
Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain
|
N/A | |
Enrolling by invitation |
NCT06087432 -
Is PNF Application Effective on Temporomandibular Dysfunction
|
N/A | |
Completed |
NCT05508594 -
Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001
|
Phase 2/Phase 3 | |
Recruiting |
NCT03646955 -
Partial Breast Versus no Irradiation for Women With Early Breast Cancer
|
N/A | |
Active, not recruiting |
NCT03472300 -
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
|
||
Completed |
NCT03678168 -
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
|
N/A | |
Completed |
NCT03286543 -
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
|
N/A | |
Completed |
NCT03931772 -
Online Automated Self-Hypnosis Program
|
N/A | |
Completed |
NCT02913027 -
Can We Improve the Comfort of Pelvic Exams?
|
N/A | |
Terminated |
NCT02181387 -
Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?
|
Phase 4 | |
Recruiting |
NCT06032559 -
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
|
Phase 3 | |
Active, not recruiting |
NCT03613155 -
Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care
|