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Clinical Trials/CTRI/2021/09/036959
CTRI/2021/09/036959Not yet recruitingNot Applicable

Efficacy of ultrasound guided bilateral subcostal transverse abdominis plane block against port site local infiltration in providing post operative analgesia in laparoscopic cholecystectomy patients - A randomised open label trial

Bangalore baptist Hospital1 site in 1 country68 target enrollmentStarted: October 10, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
68
Locations
1
Primary Endpoint
2)Total opioid requirement in first 24 hrs post operatively

Study Overview

Brief Summary

This study aims to compare the analgesic efficacy of ultrasound guided bilateral subcostal transverse abdominis plane block with that of port-site infiltration in providing post operative analgesia in patients undergoing laparoscopic cholecystectomy. The patients undergoing laparoscopic cholecystectomy will be randomly allocated into two groups. One group will receive ultrasound guided bilateral subcostal transverse abdominis plane block where as the other group will receive port-site local infiltration before surgery. Then the two groups will be assessed for post operative pain using numerical rating scale scores, use of any rescue analgesics and total opioid requirement in first 24 hrs post operatively. Any adverse events following the procedure will be noted.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

Ages
18.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients of ASA (American Society of Anesthesiologists) physical status 1,2 and 3 posted for all elective and emergency surgeries.

Exclusion Criteria

  • •Refusal to give consent for the study/procedure 2)Allergic to local anesthetic agents 3)Skin conditions precluding the block 4)Preoperative chronic dependence upon opioid medications 5)Conversion to open technique or performance of any other surgical procedure .

Outcomes

Primary Outcomes

2)Total opioid requirement in first 24 hrs post operatively

Time Frame: 1)Efficacy of postoperative analgesia as evaluated by numerical rating scale in first 24 hrs | 2)Total opioid requirement in first 24 hrs post operatively

1)Efficacy of postoperative analgesia as evaluated by numerical rating scale

Time Frame: 1)Efficacy of postoperative analgesia as evaluated by numerical rating scale in first 24 hrs | 2)Total opioid requirement in first 24 hrs post operatively

Secondary Outcomes

  • Total rescue analgesic used(Within first 24 hrs)
  • Incidence of any side effects(For first 24 hrs.)

Investigators

Sponsor Class
Research institution and hospital

Study Sites (1)

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