Ropivacaine Use Intraincisionally Versus Intraperitoneally for Post-Laparoscopic Cholecystectomy Pain
Condition: Ropivacaine; Laparoscopic Cholecystectomy; Pain
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): 0.2% ropivacaine
Intervention type(s): Drug
Intervention description(s): Intraperitoneal instillation versus intraincisional infiltration
Other intervention name(s): Ropin; Naropin
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Ropivacaine; local anesthesia; intraincisional infiltration; intraperitoneal instillation; post-laparoscopic cholecystectomy pain; shoulder pain; rescue analgesia; triple blinding