Feasibility Study on Pain Control After Laparoscopic Cholecystectomy

NCT03532906 | Completed

• 1 other identifier: 1901750
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to hopefully understand the most beneficial way to control pain after removing the gallbladder by keyhole surgery (laparoscopic cholecystectomy). The investigators will investigate two groups of patients undergoing laparoscopic cholecystectomy. One group will receive the injection of local anaesthetic into the abdominal wall (TAP block) and into the wounds; the second group will have local anaesthetic into the wounds only. In order to have meaningful results, we anticipate a large number of participants would be required. Therefore we would test first whether it is technically possible to set up the study itself. The investigators will be looking at parameters (willingness of patients to be recruited, willingness of clinicians to recruit participants, number of eligible patients, follow-up rates, adherence/compliance rates, number of participants needed for an adequate sample size) that will allow to understand if such a larger trial is technically possible to set up.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (3)

• Total amount number of patients who give their consent to take part to the study

  Overall ability to recruit participants

  24 months

• Total number of questionnaire responses

  Ability to follow-up participants

  24 months

• Total number of number of patients adhering to follow-up

  Ability to collect adequate data

  24 months

Secondary Outcomes (3)

• Standard deviation (SD) of hospital stay between the two study arms

  24 months

• Standard deviation (SD) of questionnaire scores between the two study arms

  24 months

• Standard deviation (SD) of costs (hospital stay and prescription of painkillers) between the two study arms

  24 months

Study Arms (2)

TAP block

ACTIVE COMPARATOR

Patients receive the injection of local anaesthetic into the right abdominal wall (TAP block) together with the injection of local anaesthetic into the surgical wounds.

Drug: TAP Block

Control

OTHER

Patients receive the injection of local anaesthetic into the surgical wounds only.

Drug: Control

Interventions

TAP Block DRUG

Injection of Bupivacaine 0.5% 20 ml into the thickness of the right abdominal wall and of Bupivacaine 0.5% 10 ml into the surgical wounds.

Also known as: Bupivacaine 0.5%

TAP block

Control DRUG

Injection of Bupivacaine 0.5% 10 ml into the surgical wounds

Also known as: Bupivacaine 0.5%

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients able/willing to give informed consent for participation in the study.
• Male or female aged 18-60 years old.

You may not qualify if:

• Patients having an open cholecystectomy (performed through the standard "rope" incision).
• Patients intended to have laparoscopic cholecystectomy as an inpatient (staying overnight after surgery).
• Patients initially scheduled to have day case surgery but eventually admitted to hospital due to surgical or anaesthetic concerns or social reasons.
• Patients with contraindications in having injection of the local anaesthetic used in the study (i.e. history of side-effects, allergy).
• Patients who cannot have one or more standard oral painkillers prescribed postoperatively.
• Patients with history of chronic pain who are already on long term painkillers.
• Patients unable/unwilling to give informed consent for participation in the study.

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead

Study Sites (1)

Royal Devon and Exeter NHS Foundation Trust

Exeter, EX25DW, United Kingdom

Location

Related Publications (8)

• 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: 11576144 RESULT

• Baeriswyl M, Kirkham KR, Kern C, Albrecht E. The Analgesic Efficacy of Ultrasound-Guided Transversus Abdominis Plane Block in Adult Patients: A Meta-Analysis. Anesth Analg. 2015 Dec;121(6):1640-54. doi: 10.1213/ANE.0000000000000967.

  PMID: 26397443 RESULT

• Charlton S, Cyna AM, Middleton P, Griffiths JD. Perioperative transversus abdominis plane (TAP) blocks for analgesia after abdominal surgery. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD007705. doi: 10.1002/14651858.CD007705.pub2.

  PMID: 21154380 RESULT

• Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. doi: 10.1016/j.jclinane.2010.05.008.

  PMID: 21296242 RESULT

• De Oliveira GS Jr, Castro-Alves LJ, Nader A, Kendall MC, McCarthy RJ. Transversus abdominis plane block to ameliorate postoperative pain outcomes after laparoscopic surgery: a meta-analysis of randomized controlled trials. Anesth Analg. 2014 Feb;118(2):454-463. doi: 10.1213/ANE.0000000000000066.

  PMID: 24445643 RESULT

• Pourseidi B, Khorram-Manesh A. Effect of intercostals neural blockade with Marcaine (bupivacaine) on postoperative pain after laparoscopic cholecystectomy. Surg Endosc. 2007 Sep;21(9):1557-9. doi: 10.1007/s00464-006-9181-9. Epub 2007 Mar 7.

  PMID: 17342558 RESULT

• El-Dawlatly AA, Turkistani A, Kettner SC, Machata AM, Delvi MB, Thallaj A, Kapral S, Marhofer P. Ultrasound-guided transversus abdominis plane block: description of a new technique and comparison with conventional systemic analgesia during laparoscopic cholecystectomy. Br J Anaesth. 2009 Jun;102(6):763-7. doi: 10.1093/bja/aep067. Epub 2009 Apr 17.

  PMID: 19376789 RESULT

• Chazapis M, Walker EM, Rooms MA, Kamming D, Moonesinghe SR. Measuring quality of recovery-15 after day case surgery. Br J Anaesth. 2016 Feb;116(2):241-8. doi: 10.1093/bja/aev413.

  PMID: 26787793 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Antonio Manzelli, MD, PhD

  Royal Devon and Exeter NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 22, 2018
• Study Start: July 1, 2018
• Primary Completion: April 26, 2021
• Study Completion: April 26, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)