Cholecystectomy, Laparoscopic, Pain Management
Conditions
Keywords
laparoscopic cholecystectomy, lignocaine, bupivacaine, visual analogue scale
Brief summary
To control pain after surgery for removal of gallbladder, local anesthetic agent can be sprayed on the liver bed from where the gallbladder is removed. This study was conducted to identify the ideal local anesthetic agent for this purpose.
Detailed description
Laparoscopic cholecystectomy is the gold standard operation for symptomatic cholelithiasis; however, pain remains a major factor increasing morbidity and length of hospital stay. Infiltration of gallbladder bed with local anesthetic has been shown to improve post-operative pain after laparoscopic cholecystectomy, although, it is unclear which local anesthetic provides superior pain relief. Patients undergoing laparoscopic cholecystectomies were randomized into 3 groups of 30 patients each depending on the local anesthetic instilled in the gallbladder bed; lignocaine (Group A), bupivacaine (Group B), or a combination of lignocaine and bupivacaine (Group C). Pain was measured using visual analogue score at 2-, 6-, 12- and 24-hours following surgery
Interventions
PROCEDURELocal Anesthesia
In Group A, patients received 20 ml of 1% lignocaine (Xyloaid-lignocaine HCl injection) infiltrated in the gall bladder bed after removal of the gall bladder, along with 10 ml of 1% lignocaine infiltration at the port sites at the end of the procedure. Subjects in Group B received 20 ml of 0.25% bupivacaine (Bupicain-Bupivacaine HCl injection) infiltration in gall bladder bed, along with 10 ml of 0.25% bupivacaine at port sites. In Group C patients received 10 ml of 1% lignocaine along with 10 ml of 0.25% bupivacaine infiltrated in gall bladder bed, and then 5 ml of 1% lignocaine along with 5 ml of 0.25% bupivacaine at the port sites
Sponsors
Pakistan Air Force (PAF) Hospital Islamabad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* elective/emergency laparoscopic cholecystectomy * ASA grade I/II * Ages 18-75 years
Exclusion criteria
* patients on chronic analgesics * pts receiving analgesics 24 hours prior to surgery * intraoperative bile spillage or drain placement * CBD exploration or T-tube insertion * BMI > 40 kg/m2 * pts allergic to, or otherwise not able to receive medications being tested
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scale - pain score | 2-, 6-, 12-, 24-hours following surgery | Visual analogue score to quantify pain following laparoscopic cholecystectomy. Maximum value is 10 (which means worst pain), and minimum value is 0 (which means no pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Flatus | within 24 hours following surgery | Time to passing flatus |
| nausea/vomiting | within 24 hours following surgery | time when nausea/vomiting was not present in the patient |
| Time to ambulation | within 24 hours following surgery | time after surgery when the patient started ambulating |
| Shoulder tip pain | within 24 hours following surgery | The time following surgery when shoulder tip pain was gone |
| Mean arterial pressure | 2-, 6-, 12-, 24-hours following surgery | systolic and diastolic blood pressures were measured for the patients at intervals, and then mean arterial pressures were calculated |
| Heart rate | 2-, 6-, 12-, 24 hours | Heart rate was measured at intervals in beats per minute |
| oxygen saturation | 2-, 6-, 12-, 24 hours | oxygen saturation was noted at intervals |
| rescue analgesia | within 24 hours following surgery | number of times rescue analgesia was used |
Countries
Pakistan
Outcome results
None listed