Comparing Opioids Vs NSAIDs for Postoperative Pain Management in Unilateral Primary Open Inguinal Hernia Repair

NCT ID: NCT06608056

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-06-30

Brief Summary

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To control post-operative pain, multiple drugs are available, and in the western countries opioids are preferred. However, they have their own side effects, and so to reduce their dependence, multiple adjuncts are used. We compared the use of opioids vs just non steroidal anti-inflammatory drugs on post-operative pain control following inguinal hernia surgery

Detailed Description

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Inguinal hernia repair is one of the most common surgeries performed by general surgeons worldwide. The preferred procedure for primary open inguinal hernias is open mesh repair (tension-free)-also called Lichtenstein repair. Opioids remain the mainstay for post-operative analgesia, however, they have a tendency for dependence along with other side effects. Non-steroidal anti-inflammatory drugs (NSIADs) have been used as adjuncts to decrease the use of opioids, however, usually NSAIDs are not used in isolation following surgery. We compared post-operative analgesia following primary open inguinal hernia repair, with patients receiving only opioids vs patients only receiving NSAIDs. 60 patients were randomized in to 2 groups. Group A patients received tramadol injection (opioid) every 8 hours, while patients in Group B received injection ketorolac (NSAID) every 8 hourly. Pain was measured using visual analogue score at 2-, 6-, 12- and 24-hours following surgery.

Conditions

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Inguinal Hernia Unilateral Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Tramadol

Patients received injection tramadol 50 mg intravenously every 8 hourly following surgery

Group Type EXPERIMENTAL

Pain management after surgery

Intervention Type DRUG

Patients in Group A received injection tramadol 50mg intravenously every 8 hours following surgery. Patients in Group B received injection ketorolac 30mg intravenously every 8 hours following surgery.

Ketorolac

Patients received injection tramadol 30 mg intravenously every 8 hourly following surgery

Group Type EXPERIMENTAL

Pain management after surgery

Intervention Type DRUG

Patients in Group A received injection tramadol 50mg intravenously every 8 hours following surgery. Patients in Group B received injection ketorolac 30mg intravenously every 8 hours following surgery.

Interventions

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Pain management after surgery

Patients in Group A received injection tramadol 50mg intravenously every 8 hours following surgery. Patients in Group B received injection ketorolac 30mg intravenously every 8 hours following surgery.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Undergoing elective primary unilateral open inguinal hernia repair under spinal anesthesia - Lichtenstein repair with prolene mesh
* ASA I or II
* Ages 18 - 65

Exclusion Criteria

* Patient on chronic pain meds
* Patient receiving analgesics 24hrs prior to surgery
* Incarcerated or strangulated hernia or recurrent hernia
* BMI \>40
* Allergic to medications being tested in this study
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pakistan Air Force (PAF) Hospital Islamabad

OTHER

Sponsor Role lead

Responsible Party

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Syed Moiz Ahmed

Post-graduate resident, Principle Investigator, Department of General Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pakistan Air Force Hospital

Islamabad, Capital Territory, Pakistan

Site Status

Countries

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Pakistan

References

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Bugada D, Lavand'homme P, Ambrosoli AL, Klersy C, Braschi A, Fanelli G, Saccani Jotti GM, Allegri M; SIMPAR group. Effect of postoperative analgesia on acute and persistent postherniotomy pain: a randomized study. J Clin Anesth. 2015 Dec;27(8):658-64. doi: 10.1016/j.jclinane.2015.06.008. Epub 2015 Aug 30.

Reference Type BACKGROUND
PMID: 26329661 (View on PubMed)

Zende, A.M. and R.R. Bhosale, Comparison of postoperative analgesic efficacy and safety of parecoxib and ketorolac in patients of inguinal hernia. International Journal of Basic and Clinical Pharmacology, 2013. 2(4): p. 414-20.

Reference Type 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.

Reference Type BACKGROUND
PMID: 30211382 (View on PubMed)

De Oliveira GS Jr, Agarwal D, Benzon HT. Perioperative single dose ketorolac to prevent postoperative pain: a meta-analysis of randomized trials. Anesth Analg. 2012 Feb;114(2):424-33. doi: 10.1213/ANE.0b013e3182334d68. Epub 2011 Sep 29.

Reference Type BACKGROUND
PMID: 21965355 (View on PubMed)

Pavy TJ, Paech MJ, Evans SF. The effect of intravenous ketorolac on opioid requirement and pain after cesarean delivery. Anesth Analg. 2001 Apr;92(4):1010-4. doi: 10.1097/00000539-200104000-00038.

Reference Type BACKGROUND
PMID: 11273941 (View on PubMed)

Chen JY, Wu GJ, Mok MS, Chou YH, Sun WZ, Chen PL, Chan WS, Yien HW, Wen YR. Effect of adding ketorolac to intravenous morphine patient-controlled analgesia on bowel function in colorectal surgery patients--a prospective, randomized, double-blind study. Acta Anaesthesiol Scand. 2005 Apr;49(4):546-51. doi: 10.1111/j.1399-6576.2005.00674.x.

Reference Type BACKGROUND
PMID: 15777304 (View on PubMed)

National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse; Phillips JK, Ford MA, Bonnie RJ, editors. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington (DC): National Academies Press (US); 2017 Jul 13. Available from http://www.ncbi.nlm.nih.gov/books/NBK458660/

Reference Type BACKGROUND
PMID: 29023083 (View on PubMed)

Goettsch WG, Sukel MP, van der Peet DL, van Riemsdijk MM, Herings RM. In-hospital use of opioids increases rate of coded postoperative paralytic ileus. Pharmacoepidemiol Drug Saf. 2007 Jun;16(6):668-74. doi: 10.1002/pds.1338.

Reference Type BACKGROUND
PMID: 17072916 (View on PubMed)

Barletta JF, Asgeirsson T, Senagore AJ. Influence of intravenous opioid dose on postoperative ileus. Ann Pharmacother. 2011 Jul;45(7-8):916-23. doi: 10.1345/aph.1Q041. Epub 2011 Jul 5.

Reference Type BACKGROUND
PMID: 21730280 (View on PubMed)

Garimella V, Cellini C. Postoperative pain control. Clin Colon Rectal Surg. 2013 Sep;26(3):191-6. doi: 10.1055/s-0033-1351138.

Reference Type BACKGROUND
PMID: 24436674 (View on PubMed)

Kehlet H, Holte K. Effect of postoperative analgesia on surgical outcome. Br J Anaesth. 2001 Jul;87(1):62-72. doi: 10.1093/bja/87.1.62. No abstract available.

Reference Type BACKGROUND
PMID: 11460814 (View on PubMed)

Carr DB, Goudas LC. Acute pain. Lancet. 1999 Jun 12;353(9169):2051-8. doi: 10.1016/S0140-6736(99)03313-9.

Reference Type BACKGROUND
PMID: 10376632 (View on PubMed)

Mulita F, Parchas N, Solou K, Tchabashvili L, Gatomati F, Iliopoulos F, Maroulis I. Postoperative Pain Scores After Open Inguinal Hernia Repair: Comparison of Three Postoperative Analgesic Regimens. Med Arch. 2020 Oct;74(5):355-358. doi: 10.5455/medarh.2020.74.355-358.

Reference Type BACKGROUND
PMID: 33424089 (View on PubMed)

Burton, V. and P. A.J., Comparison of open and laparoscopic inguinal hernia repair. Mini-invasive Surgery, 2021. 5(26).

Reference Type BACKGROUND

Fitzgibbons RJ Jr, Ramanan B, Arya S, Turner SA, Li X, Gibbs JO, Reda DJ; Investigators of the Original Trial. Long-term results of a randomized controlled trial of a nonoperative strategy (watchful waiting) for men with minimally symptomatic inguinal hernias. Ann Surg. 2013 Sep;258(3):508-15. doi: 10.1097/SLA.0b013e3182a19725.

Reference Type BACKGROUND
PMID: 24022443 (View on PubMed)

Hammoud, M. and J. Gerken, Inguinal Hernia, in StatPearls. 2022: Treasure Island (FL).

Reference Type BACKGROUND

Other Identifiers

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SGR-2021-137-2499-2

Identifier Type: OTHER

Identifier Source: secondary_id

SGR-2021-137-2499-2

Identifier Type: -

Identifier Source: org_study_id

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