Comparison of effects of wound infiltration with Dexamethasone versus Dexmedetomidine with Ropivacaine on post operative pain in Laparoscopic Cholecystectomy

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2022/05/042384

Lead Sponsor: sharda hospital

Brief Summary: Laparoscopiccholecystectomy is the mainstay treatment of gall bladder diseases due to itsadvantages such as less postoperative pain, short hospital stay, bettercosmetic results, and less cost over open cholecystectomy.

40%of the patients manifest pain of moderate to severe intensity in the first 24hours after laparoscopic cholecystectomy, with a predominance of incisionalpain in incidence and intensity, compared with visceral pain and referred painto the shoulder.

Postoperativepain management not only minimizes patient suffering but also can reducecardio-respiratory morbidity and facilitate rapid recovery. Multimodalanalgesia is one of the techniques used to treat postoperative pain which, whencombining medications with additive or synergistic effects and differentmechanisms of action, not only improves the efficiency of individual drug butalso reduces their secondary effects.

Althoughregional anaesthetictechniques, such as epidural analgesia or perineural catheters, have proven toprovide excellent analgesia, many of these analgesic modalities are time consuming,expensive, and has side effects such as dislocation of catheters or catheterinfection.

Asa significant proportion of surgical pain originates from the surgical wound,incisional infiltration with local anaestheticswould seem logical to manage perioperative pain. Local wound infiltration is anefficacious strategy with minimal side effects.

Nowadays,there is a trend toward preferring ropivacaine over other local anaestheticagents due to longer duration of action and better safety profile.

Localanaestheticinfiltration, however, has a limitation in pain relief as it is effective tillthe effects of local anaestheticaction lasts, which can further extended by using adjuvants to local anaestheticagents like dexamethasone, dexmedetomidine etc. Glucocorticoids are indicatedfor the relief of incisional pain in several surgical procedures as theinflammation caused by tissue injury plays an important role in pain.

Dexamethasonecan be used alone or as an adjuvant treatment. However, the usual route ofadministration to increase the duration of the analgesia and to reduce theintensity of the pain is intravenous. Other routes of use such as localinfiltration provides maximum concentration of drug at the wound site and withlower systemic toxicity.

RecentlyDexmedetomidine, a highly selective alpha 2-adrenergic receptor agonist hasbeen used by various routes including local infiltration as adjuvant to local anaesthesticagents for postoperative analgesia. It has the broad spectrum properties(sedative, analgesic and anaestheticsparing), making it a useful and safe adjunct in many clinical applications.

Bothdrugs Dexamethasone and Dexmedetomidine have been used as adjuvants to local anaestheticsin wound infiltration for post operative pain relief.

Extensivesearch of literature did not reveal any study to compare the effects of thesetwo drugs as adjuvant to Ropivacaine in port site infiltration in the patientsof laparoscopic cholecystectomy. So, in the present study, both drugs will beused as adjuvant to ropivacaine to compare their effect on post operative painfollowing their infiltration at the port sites in laparoscopic cholecystectomy.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Patients scheduled for elective laparoscopic cholecystectomy through four ports under general anaesthesia.
ASA class I and II 3.
Age 18-60 years 4.
Both genders.

Exclusion Criteria

Patients receiving steroids, analgesics, antiemetic and sedatives.
Patients with past history of chronic pain.
Patients having history of endocrine, cardiovascular, renal or CNS disease.
Patients allergic to study drugs.
BMI > 30 kg m-2.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the post operative pain score following port site infiltration with dexamethasone versus dexmedetomidine as adjuvant to ropivacaine (0.5%) in the patients of laparoscopic cholecystectomy.	upto 24 hours

Secondary Outcome Measures

Name	Time	Method
1.To compare the duration of post operative analgesia in three groups	2. To compare the hemodynamic parameters (HR, SBP, DBP, MAP) post operatively

Trial Locations

Locations (1): sharda hospital, school of medical sciences and research
🇮🇳
Nagar, UTTAR PRADESH, India
sharda hospital, school of medical sciences and research
🇮🇳Nagar, UTTAR PRADESH, India
Dr Nupur Aggarwal
Principal investigator
9654145106
nupur.aggarwal@sharda.ac.in