Comparison of Intraperitoneal administration (giving drug into the abdominal cavity) of Ropivacaine (local anaesthetic) with Dexmedetomidine (sedative) Versus Ropivacaine with Ketamine (sedative) for Post Operative Pain Relief Following Laparoscopic Cholecystectomy

Not Applicable

Completed

Conditions: Cholelithiasis,

Registration Number: CTRI/2019/11/022129

Lead Sponsor: UCMS and GTB Hospital

Brief Summary: **RATIONALE:**Intraperitoneal local anaesthetic instillation is a well established technique for pain relief in laparoscopic cholecystectomy with Bupivacaine being a commonly used drug in most of the studies. Ropivacaine has been used of late and with addition of adjuncts it provides adequate postoperative pain relief. Dexmedetomidine has been successfully used as an adjunct to ropivacaine for intraperitoneal instillation with prolonged duration of postoperative analgesia. Intraperitoneal Ketamine alone or with Bupivacaine has been found to have prolonged duration of analgesia. However, no study is available in literature which compares the efficacy of these two drugs as adjuncts to Ropivacaine for postoperative pain relief. Therefore, the present randomized double blinded controlled study is designed to compare the efficacy of intraperitoneal instillation of Ropivacaine with Dexmedetomidine versus Ropivacaine with Ketamine for postoperative pain relief following laparoscopic cholecystectomy.

**AIM:** To compare the efficacy of intraperitoneal instillation of Ropivacaine with Dexmedetomidine versus Ropivacaine with Ketamine for postoperative pain relief following laparoscopic cholecystectomy

**OBJECTIVES**

**Primary Objective:** To compare the time to demand of first dose of rescue analgesic between the three groups.

**Secondary Objective:**

To compare-

1.    Time to extubation.

2.    Hemodynamic parameters at the time of extubation

3.    Post-operative pain using Numeric Rating Scale (NRS).

4.    Total dose of rescue analgesia required in 24 hours

5.    Any adverse effects

6.    To assess the quality of post operative pain using Revised American Pain Society Patient Outcome Questionnaire.

**MATERIALS AND METHODS**

**Place of study:**

The study will be conducted in the Department of Anaesthesiology, Critical Care & Pain Medicine at University College of Medical Sciences and G.T.B Hospital, Shahdara, Delhi-95 after getting approval from the Institutional Ethics Committee-Human Research (IEC-HR). Informed written consent will be obtained from each patient willing to participate in the study.

**Study design:** A randomized double blinded controlled study

**Duration of Study:** Nov 2019 to April 2021

**Blinding:** Study drugs will be prepared by an independent anaesthesiologist and medication will be administered as per the group allocated. Both patient and observer will not be aware of the group or medication.

**Participants:** Total 60 patients, 20 in each group

**Inclusion Criteria:**

Patients having following criteria will be included in the study:

Patients of either gender giving consent for the study and aged 20-55 years belonging to ASA grade I or II scheduled for elective laparoscopic cholecystectomy under general anaesthesia.

**Exclusion Criteria:**

1.    Patients with cardiovascular, pulmonary, psychological or neurological diseases

2.    Patients who are known to be epileptic

3.    Patients who have an increase in intracranial tension

4.    Patients with known allergies to the study drugs

5.    Patients with abnormalities like heart block, left bundle branch block

6.    Patients in whom the procedure will be converted to open cholecystectomy

7.    Obese patients (BMI more than or equal to 30)

8. Patients in whom subhepatic drain is inserted after the removal of gall bladder.

  **Allocation:**

Sixty patients fulfilling the above mentioned selection criteria will be divided into the following two groups by a computer generated random number chart.

**Group R (n=20)**[Control group]**:** Each patient will receive 0.2% plain Ropivacaine in a total volume of 40 ml of instilled solution.

**Group RD (n=20):** Each patient will receive 0.7Âµg/kg Dexmedetomidine mixed with 0.2% Ropivacaine in a total volume of 40 ml of instilled solution.

**Group RK (n=20):** Each patient will receive 0.5 mg/kg Ketamine mixed with 0.2% Ropivacaine in a total volume of 40 ml of instilled solution.

Standard general anaesthesia will be given to every patient participating in the study and after surgery, time to demand of first dose of analgesia, total dose of rescue analgesia and hemodynamic parameters will be recorded. Any side effects during the post operative period will also be noted.

**OUTCOME MEASURES:**

**Primary outcome:** Time to demand of first dose of rescue analgesia in the three groups

**Secondary outcome:** To compare in the three groups:

1.    Time to extubation.

2.    Hemodynamic parameters at the time of extubation

3.    Post-operative pain using Numeric Rating Scale (NRS).

4.    Total dose of rescue analgesia required in 24 hours

5.    Any adverse effects

6.    To assess the quality of post operative pain using Revised American Pain Society Patient Outcome Questionnaire.

**STATISTICAL ANALYSIS:**

One time quantitative measurements will be compared by one way ANOVA followed by Tukeyâ€™s test and repeatedly measured by repeated measure ANOVA followed by Dunnettâ€™s test. Qualitative parameters will be compared by Chi-square test. p value of < 0.05 will be considered as significant. This analysis will be carried out in SPSS 20.0.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

Patients of either gender giving consent for the study and aged 20-55 years belonging to ASA grade I or II scheduled for elective laparoscopic cholecystectomy under general anaesthesia.

Exclusion Criteria

1.Patients with cardiovascular, pulmonary, psychological or neurological diseases 2.Patients who are known to be epileptic 3.Patients who have an increase in intracranial tension 4.Patients with known allergies to the study drugs 5.Patients with abnormalities like heart block, left bundle branch block 6.Patients in whom the procedure will be converted to open cholecystectomy 7.Obese patients (BMI more than or equal to 30) 8.Patients in whom subhepatic drain is inserted after the removal of gall bladder.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to demand of first dose of rescue analgesia in the three groups	Once, during first 24 hours, when patient complains of pain and NRS is more than or equal to 4

Secondary Outcome Measures

Name	Time	Method
Time to extubation.
Hemodynamic parameters at the time of extubation	Intraoperative, Immediate postoperative, 5 mins, 10 mins, 15 mins, 30 mins, 1h, 1 h 30 mins, 2h, 3h, 4h, 5h, 6h, 7h, 8h
Post-operative pain using Numeric Rating Scale (NRS)- Static and Dynamic.	30 min, 1 h, 2h, 3h, 4 h, 6h, 8 h, 12 h, 18 h and 24 h postoperatively
Total dose of rescue analgesia required	First 24 hours
Any adverse effects	first 24 hours
To assess the quality of post operative pain using Revised American Pain Society Patient Outcome Questionnaire.	After 24 hours

Trial Locations

Locations (1): UCMS & GTB Hospital
🇮🇳
East, DELHI, India
UCMS & GTB Hospital
🇮🇳East, DELHI, India
Dr Ruchi Kapoor
Principal investigator
9560678023
rudoc@rediffmail.com