NCT05856682

Brief Summary

The goal of this clinical trial is to compare pre-incision vs laparoscopic assisted Transversus abdominis plane and rectus sheath block in patients undergoing laparoscopic cholecystectomy. The main question it aims to answer is: • if the effectiveness of TAP and rectus sheath block varies according to whether it is performed pre-incisional (pre emptive) or intraoperatively under Laparoscopic vision for laparoscopic cholecystectomies. Participants will be assessed for pain at 3,6,12, and 24 hrs after surgery. Researchers will compare pain score between Laparoscopic-assisted TAP block(LATAP) and Rectus Sheath block vs Pre-incision TAP (PITAP ) .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

11 months

First QC Date

April 21, 2023

Last Update Submit

May 3, 2023

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

  • Post-operative pain changes

    post operative chnage of pain score assessment at 3,6,12,24 hrs at resting and coughing. Pain score will be assessed using VAS score

    3,6,12,24 hrs post-operatively

Secondary Outcomes (4)

  • Rescue analgesia need

    Post operatively at 3,6,12,24hrs

  • Visceral Injury

    at the time of surgery

  • Peritoneal injury

    at the time of surgery

  • TAP and rectus sheath block timings

    at the time of surgery

Study Arms (2)

Pre-incision TAP (PITAP) and Rectus Sheath block

ACTIVE COMPARATOR

Pre-incision TAP block and Rectus sheath block will be performed after induction of anesthesia, just after prep and drape by Blind double pop technique by Anesthetist/Anesthesia trainee.Site of rectus block will be Bilaterally 3 cm lateral to Umblicus and 3cm lateral to midpoint between xiphisternum and umbilicus . Site of TAP block will be Immediate right subcostal region , 3 cm medially to mid axillary line The intervention and the control group will receive TAP block and rectus sheath block with Rupivacaine (3mg/kg). 1 ampule is of 10 ml and consists of 50mg /10ml, maximum dose will be 300mg. will use a of minimum volume of solution 50ml which will be made by 3 ampules of Rupivacaine and it will be diluted to a total of 20ml of injectate( distilled water )which is then divided between the four rectus block sites (5ml each) and one TAP block site(30ml ).

Procedure: Laparoscopic-assisted TAP block(LATAP) and Rectus Sheath block

Laparoscopic-assisted TAP block(LATAP) and Rectus Sheath block

ACTIVE COMPARATOR

Laparoscopic -assisted TAP and rectus sheath block will be performed after insertion of optical port By Surgeon /surgery trainee.Site of rectus block will be Bilaterally 3 cm lateral to Umblicus and 3cm lateral to midpoint between xiphisternum and umbilicus . Site of TAP block will be Immediate right subcostal region , 3 cm medially to mid axillary line The intervention and the control group will receive TAP block and rectus sheath block with Rupivacaine (3mg/kg). 1 ampule is of 10 ml and consists of 50mg /10ml, maximum dose will be 300mg. will use a of minimum volume of solution 50ml which will be made by 3 ampules of Rupivacaine and it will be diluted to a total of 20ml of injectate( distilled water )which is then divided between the four rectus block sites (5ml each) and one TAP block site(30ml each).

Procedure: Laparoscopic-assisted TAP block(LATAP) and Rectus Sheath block

Interventions

Laparoscopic-assisted TAP block(LATAP) and Rectus Sheath blockPROCEDURE

Laparoscopic -assisted TAP and rectus sheath block will be performed after insertion of optical port By Surgeon /surgery trainee. • Site of rectus block will be Bilaterally 3 cm lateral to Umblicus and 3cm lateral to midpoint between xiphisternum and umbilicus . Site of TAP block will be anterior to the midaxillary line between the costal margin and iliac crest bilaterally.

Also known as: Pre-incision TAP (PITAP) and Rectus Sheath block
Laparoscopic-assisted TAP block(LATAP) and Rectus Sheath blockPre-incision TAP (PITAP) and Rectus Sheath block

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age above 18 to 75 years, both genders, Elective Laparoscopic Cholecystectomies, American Society of Anesthesiologists (ASA) physical status I \& II, Give consent.

You may not qualify if:

  • o History of allergy , hypersentivity or contraindication to Rupivacaine, nalbuphine ,Paracetamol.
  • Local skin allergy
  • Laparoscopic converted to open
  • Previous open upper abdominal or midline surgeries
  • Diagnosis Of "Chronic Pain Syndrome"
  • Known Alcohol Or Substance Abuse Within The Last 6 Months
  • Anti-psychotic, antidepressants, steroids use
  • Multiple procedures planned under single GA
  • Pregnancy
  • Unable to understand i.e. deaf, language barrier, mentally incapacitated
  • Coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Patel Hospital

Karachi, Sindh, 75300, Pakistan

Location

Related Publications (11)

  • Amreek F, Hussain SZM, Mnagi MH, Rizwan A. Retrospective Analysis of Complications Associated with Laparoscopic Cholecystectomy for Symptomatic Gallstones. Cureus. 2019 Jul 16;11(7):e5152. doi: 10.7759/cureus.5152.

    PMID: 31523579BACKGROUND

  • Csikesz NG, Singla A, Murphy MM, Tseng JF, Shah SA. Surgeon volume metrics in laparoscopic cholecystectomy. Dig Dis Sci. 2010 Aug;55(8):2398-405. doi: 10.1007/s10620-009-1035-6. Epub 2009 Nov 13.

    PMID: 19911275BACKGROUND

  • Ortiz J, Rajagopalan S. A review of local anesthetic techniques for analgesia after laparoscopic surgery. J Minim Invasive Surg Sci. 2014;3:e11310

    BACKGROUND

  • Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31.

    PMID: 29226150BACKGROUND

  • Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.

    PMID: 11576144BACKGROUND

  • Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.

    PMID: 18020088BACKGROUND

  • Elamin G, Waters PS, Hamid H, O'Keeffe HM, Waldron RM, Duggan M, Khan W, Barry MK, Khan IZ. Efficacy of a Laparoscopically Delivered Transversus Abdominis Plane Block Technique during Elective Laparoscopic Cholecystectomy: A Prospective, Double-Blind Randomized Trial. J Am Coll Surg. 2015 Aug;221(2):335-44. doi: 10.1016/j.jamcollsurg.2015.03.030. Epub 2015 Mar 27.

    PMID: 25899736BACKGROUND

  • Chetwood A, Agrawal S, Hrouda D, Doyle P. Laparoscopic assisted transversus abdominis plane block: a novel insertion technique during laparoscopic nephrectomy. Anaesthesia. 2011 Apr;66(4):317-8. doi: 10.1111/j.1365-2044.2011.06664.x. No abstract available.

    PMID: 21401554BACKGROUND

  • Mughal A, Khan A, Rehman J, Naseem H, Waldron R, Duggan M, Khan W, Barry K, Khan IZ. Laparoscopic-assisted transversus abdominis plane block as an effective analgesic in total extraperitoneal inguinal hernia repair: a double-blind, randomized controlled trial. Hernia. 2018 Oct;22(5):821-826. doi: 10.1007/s10029-018-1819-8. Epub 2018 Sep 1.

    PMID: 30173291BACKGROUND

  • Chapter 57 - Rectus Sheath Block, Editor(s): Andrew T. Gray, Atlas of Ultrasound-Guided Regional Anesthesia (Third Edition),Elsevier, 2019,Pages 249-258,ISBN 9780323509510.

    BACKGROUND

  • Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.

    PMID: 30211382BACKGROUND

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double blinded study : participants and person assessing the post operative pain will be blinded to both the control and intervention group, person performing TAP block will not be assessing the outcome
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized, prospective, double blinded
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kanwal Nisa

Study Record Dates

First Submitted

April 21, 2023

First Posted

May 12, 2023

Study Start

July 1, 2022

Primary Completion

June 1, 2023

Study Completion

August 1, 2023

Last Updated

May 12, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)